更新于：2024-09-30
Baricitinib
巴瑞替尼
更新于：2024-09-30
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、紧急使用授权 (美国)、孤儿药 (美国)、特殊审批 (中国) |
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结构
分子式C16H17N7O2S |
InChIKeyXUZMWHLSFXCVMG-UHFFFAOYSA-N |
CAS号1187594-09-7 |
关联
239
项与 巴瑞替尼 相关的临床试验PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial"
PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.
开始日期2026-04-01 |
REVERSE-Long COVID: A Multicenter Randomized, Placebo-Controlled Clinical Trial of Immunomodulation (With Baricitinib) for Long COVID Related Cognitive Impairment and ADRD (Alzheimer's Disease and Related Dementias)
REVERSE-LC is a phase 3 trial of baricitinib versus placebo in adults with neurocognitive impairment (a form of Alzheimer's Disease and Related Dementias or ADRD) or cardiopulmonary symptoms due to Long COVID.
开始日期2024-10-31 |
申办/合作机构 |
A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas
Hepatocellular adenomas (HCA) are tumors rare benign hepatic infections that develop on a liver normal and in young women taking a estrogen-based contraception. The main molecular subgroup of AHCs is the AHC subgroup inflammatory, which are associated with a risk of bleeding from the tumor and malignant transformation. Therefore, most of women with large inflammatory AHC (>5 cm) require liver resection which can be associated with morbidity and aesthetic problems, and rarely to mortality. On the basis of the knowledge of the molecular classification of AHCs humans and preclinical data testing the JAK1/2 inhibitors, we hypothesize that a short duration of treatment with the inhibitor of JAK1/2 (baricitinib) may be effective in patients with large inflammatory AHC size.
开始日期2024-09-02 |
100 项与 巴瑞替尼 相关的临床结果
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100 项与 巴瑞替尼 相关的转化医学
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100 项与 巴瑞替尼 相关的专利（医药）
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1,501
项与 巴瑞替尼 相关的文献（医药）2024-12-31·JOURNAL OF MEDICAL ECONOMICS
Re: Johansson E, Giovannitti M, Mezzetti M, et al. Cost-effectiveness analysis of baricitinib versus dupilumab for moderate to severe atopic dermatitis: an Italian healthcare system perspective. J Med Econ. 2023;26(1):1155–1166
Letter
作者: Noonan, Kerry ; Pedone, Maria Paola ; Tavi, Jules ; Dobreva, Miryana ; Bastian, Mike
2024-12-31·The Journal of dermatological treatment
Complete response of extensive alopecia areata refractory to baricitinib after five months of treatment with upadacitinib
Article
作者: Velasco-Amador, Juan Pablo ; Prados-Carmona, Álvaro ; De la Torre-Gomar, Francisco Javier ; Ruiz-Villaverde, Ricardo
A case study of 45-yr-old woman presented with a 9-yr history of alopecia areata and atopic dermatitis for evaluation of a new relapse.The authors assessed the response after the patient experienced a relapse of his pathol. while being treated with baricitinib, which supports the importance of selective JAK1 inhibition to improve alopecia areata and suggests the possible efficacy of upadacitinib after loss of response to baricitinib.
2024-12-31·The Journal of dermatological treatment
Alopecia areata treatment with baricitinib: different relapse phenotypes
Article
作者: Nasca, Maria Rita ; Lacarrubba, Francesco ; Dall'Oglio, Federica ; Vitale, Pasquale ; Micali, Giuseppe
A 28-yr-old woman with a history of AA universalis since 5 years of age with transient response to different AA treatments, including intralesional corticosteroids, contact immunotherapy with squaric acid dibutylester (SAdBe), cyclosporine, and methotrexate.Laboratory investigations were unremarkable, showing only mild anemia.Trichoscopy, showing black dots and exclamation mark hairs, and histopathol. confirmed the diagnosis of active AA.A 43-yr-old woman with severe AA (SALt = 70) occurred 2 years earlier.A 52-yr-old woman with severe AA (SALt = 90) occurred 2 years earlier unresponsive to previous treatments with systemic corticosteroids and methotrexate.Our observations confirm that AA relapses may occur during baricitinib treatment.Interestingly, hair loss developed either within the regrowth area as seen in Cases 1 and 3 or in a healthy area previously unaffected as in Case 2, confirming two different presentation phenotypes.
469
项与 巴瑞替尼 相关的新闻（医药）2024-09-27
In the Phase 3b/4 PSORIATYK SCALP trial
Sotyktu
was superior to placebo across all primary and secondary endpoints at Week 16, with patients reporting significantly greater improvement in symptoms
Safety pro PSORIATYK SCALP was consistent with the established safety pro
Sotyktu
In the real-world RePhlect registry of patients, six months of
Sotyktu
treatment was consistent with the efficacy outcomes observed in the POETYK clinical studies for psoriasis
PRINCETON, N.J.--(BUSINESS WIRE)--
$BMY
#PSORIATYK
--
Bristol Myers Squibb
(NYSE:BMY) today announced positive results from the Phase 3b/4 PSORIATYK SCALP trial evaluating
Sotyktu
(deucravacitinib) for the treatment of patients with moderate-to-severe scalp psoriasis, including those with less extensive overall psoriasis. The primary endpoint was met, with a statistically significant improvement in the scalp-specific Physician’s Global Assessment (ss-PGA) response of 0 or 1 (clear/almost clear) at 16 weeks, with more than three times as many patients achieving ss-PGA 0/1 with
Sotyktu
treatment compared to those on placebo (48.5% versus 13.7%, respectively; p<0.0001).
The new PSORIATYK SCALP efficacy and safety results (oral presentation FC04.07, abstract #5627), patient-reported outcomes (oral presentation FC06.06, abstract #5390) and 23 additional abstracts are being presented at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, Netherlands taking place September 25-28, 2024.
“Approximately 80% of people living with plaque psoriasis have scalp involvement and typically experience itching, flaking, pain and bleeding, which greatly diminish their quality of life,” said Mark Lebwohl, MD, dean of Clinical Therapeutics at the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai and an investigator and paid consultant for Bristol Myers Squibb. “These new results reinforce that oral
Sotyktu
is a safe and effective once-daily treatment for people living with moderate-to-severe psoriasis, with involvement of high impact areas such as the scalp.”
The trial also met key secondary endpoints at Week 16, with a significantly higher percentage of patients achieving at least a 90% improvement in Psoriasis Scalp Severity Index (PSSI) response and a change from baseline (CFB) in scalp-specific itch with
Sotyktu
treatment compared with placebo (PSSI 90: 38.8% versus 2.0%, respectively, p<0.0001; mean CFB in scalp-specific itch -3.2 versus -0.7, respectively, p<0.0001). In patients with Static Physician’s Global Assessment (sPGA) ≥3, a greater proportion achieved sPGA 0/1 with
Sotyktu
treatment versus placebo (51.0% versus 4.3%; p<0.0001).
Greater improvements were also reported by patients receiving
Sotyktu
versus placebo, respectively, in achieving the minimum clinically important difference (MCID) for scalp-specific itch (41.7% versus 9.8%; p<0.0001), pain (26.2% versus 11.8%; p=0.0372) and flaking (53.4% versus 19.6%; p<0.0001), as well as whole-body itch (39.8% versus 13.7%; p=0.0009) numeric rating scale (NRS) scores.
The safety pro
Sotyktu
in PSORIATYK SCALP was consistent with findings in previously conducted clinical trials of
Sotyktu
in psoriasis. The most common adverse events associated with
Sotyktu
treatment in the PSORIATYK SCALP trial were nasopharyngitis (14.6%), upper respiratory tract infection (11.7%), acne (9.7%), headache (7.8%), COVID-19 (5.8%) and pustular acne (5.8%).
Real-world analysis demonstrates consistent effectiveness with
Sotyktu
An interim analysis (poster #P3311, abstract #5500) of the Registry of Psoriasis Health Outcomes: A Longitudinal Real-World Collaboration Study (RePhlect) evaluated 118 patients, 108 of whom had moderate-to-severe plaque psoriasis. This analysis found that the effectiveness after six months of continuous
Sotyktu
treatment in real-world registry patients was consistent with efficacy outcomes observed in the POETYK PSO clinical studies in patients living with moderate-to-severe plaque psoriasis.
Findings showed that patients in the overall group achieved statistically significant mean decreases in measures of disease severity (67.9% achieved Psoriasis Area and Severity Index (PASI) scores ≤3; PASI mean baseline score 6.3, change from baseline -4.1, p<0.001), percentage of affected Body Surface Area (BSA) scores (64.1% of patients achieved a BSA ≤3%; BSA mean baseline score 9.3, change from baseline -5.8, p<0.001) and Investigator’s Global Assessment (IGA) scores (46.8% achieved IGA scores of 0/1; IGA mean baseline score 2.7, change from baseline -1.2, p<0.001) from baseline to follow-up. Similar results were observed in the subset of patients with moderate-to-severe plaque psoriasis.
“These data further demonstrate the safety and efficacy of
Sotyktu
for the treatment of psoriasis in high-impact areas, such as the scalp, and include the first analysis from our RePhlect registry providing evidence highlighting the real-world benefit of
Sotyktu
for the treatment of moderate-to-severe plaque psoriasis,” said Daniel Quirk, MD, MPH, MBA, senior vice president, worldwide Immunology and Neuroscience medical affairs, Bristol Myers Squibb. “We believe
Sotyktu
has the potential to be the systemic therapy that healthcare providers turn to when treating adult patients with moderate-to-severe psoriasis, especially those with scalp involvement. Overall, these promising results reinforce once-daily
Sotyktu
as a potential oral standard of care as we continue to lead in TYK2 innovation.”
Sotyktu
is also being studied in clinical trials across multiple immune-mediated diseases.
Bristol Myers Squibb thanks the patients and investigators involved in the ongoing PSORIATYK SCALP trial and RePhlect study.
About the PSORIATYK SCALP Trial
PSORIATYK SCALP (NCT05478499) is an ongoing, 52-week, Phase 3b/4 multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of
Sotyktu
in patients with moderate-to-severe scalp psoriasis, as defined by scalp-specific Physician’s Global Assessment (ss-PGA) ≥3, Psoriasis Scalp Severity Index (PSSI) ≥12 and Scalp Surface Area (SSA) ≥20%, who also had body surface area involvement ≥3%.
The Week 16 efficacy and safety analysis included 154 patients (
Sotyktu
, n=103; placebo, n=51).
The primary endpoint was the percentage of patients who achieved a ss-PGA score of 0 or 1 (clear/almost clear) at Week 16. Key secondary endpoints were the percentage of patients who achieved a PSSI response 90, defined as at least a 90% improvement in PSSI, change from baseline in scalp-specific itch and static Physician’s Global Assessment (sPGA) 0/1 at Week 16. Endpoints were evaluated for the overall population and the subpopulation with global sPGA score ≥3.
About the Registry of Psoriasis Health Outcomes: A Longitudinal Real-World Collaboration Study (RePhlect)
RePhlect (NCT05744466) is a prospective, observational, real-world study of adult patients with dermatologist-diagnosed psoriasis, with a targeted sample size of 2,500
Sotyktu
patients in six countries (United States, Canada, United Kingdom, Germany, Japan and France). The enrollment of the study began in September 2023.
RePhlect North American cohort (United States and Canada) data are collected through the CorEvitas Psoriasis Registry, currently enrolling patients across 263 private and academic clinical sites from 596 physicians in 40 states in the United States and seven Canadian provinces.
The design and conduct of the RePhlect North American cohort study was a collaborative effort between CorEvitas and Bristol Myers Squibb, with financial support for the research provided by Bristol Myers Squibb. The CorEvitas Psoriasis Registry was developed in collaboration with the National Psoriasis Foundation.
About Psoriasis
Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and approximately 7.5 million people in the United States. Nearly one-quarter of people with psoriasis have cases that are considered moderate-to-severe. Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales. Despite the availability of effective systemic therapy, many patients with moderate-to-severe plaque psoriasis remain undertreated or even untreated and are dissatisfied with current treatments.
People with psoriasis report an impact on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life. Psoriasis is associated with multiple comorbidities that may impact patients’ well-being, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease and depression.
Scalp psoriasis, which occurs in approximately 80% of patients with plaque psoriasis, is associated with itching, flaking, pain and bleeding and disproportionately reduces health-related quality of life. Scalp psoriasis can be challenging to treat with topical agents and there are limited available published data about the efficacy of systemic agents in the treatment of moderate-to-severe scalp disease.
About
Sotyktu
(deucravacitinib)
Sotyktu
(deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed
Sotyktu
to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases.
Sotyktu
achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions.
Sotyktu
selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses,
Sotyktu
does not inhibit JAK1, JAK2 or JAK3.
Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and pulmonology. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life.
SOTYKTU U.S. INDICATION
SOTYKTU
®
(deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use:
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity:
Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections:
SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB):
In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas:
Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK:
Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo.
Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities:
Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations:
Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition:
It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS
Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy:
Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation:
There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment:
SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see
U.S. Full Prescribing Information
, including
Medication Guide
, for SOTYKTU.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at
BMS.com
or follow us on
LinkedIn
,
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and
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that results of future post-marketing studies will be consistent with the results of these studies, that
Sotyktu
(deucravacitinib) for the indication described in this release may not be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of
Sotyktu
for such indication may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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临床结果
2024-09-26
New data demonstrate improved hair satisfaction in more than 95% of patients taking deuruxolitinib and clinically meaningful improvements in depression and anxiety from baseline to Week 24
Studies also confirm dose optimization, with results demonstrating greater response with 8 mg tablets twice-daily as compared to higher once-daily dosing
MUMBAI, India and PRINCETON, N.J., Sept. 26, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") today announced that it will present abstracts across its dermatology portfolio at the 33rd European Academy of Dermatology and Venereology (EADV) Congress being held in Amsterdam, Netherlands from September 25-28, 2024.
Three abstracts, accepted for podium and poster presentation, will highlight clinical efficacy and safety data of LEQSELVI™ (deuruxolitinib) 8 mg tablets, an oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2 approved by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata (AA). Notably, data presented in the podium presentation (FC04.04) found a greater proportion (95%) of patients taking deuruxolitinib 8 mg twice a day showed improvement in their hair satisfaction scores, compared to baseline over the 24-week period. Satisfaction with hair regrowth is imperative, as a significant number of patients with AA experience depression and anxiety due to the visible nature of the disease.1 The company will also share results in two additional posters for deuruxolitinib, which showed clinically meaningful improvement in anxiety and depression among patients taking deuruxolitinib to treat their severe AA (P2022) as well as dose optimization for deuruxolitinib at 8 mg (P2081).
"Deuruxolitinib targets the immune mechanisms behind alopecia areata, providing patients with an effective treatment option," said Arash Mostaghimi, MD, MPA, MPH, FAAD, Vice Chair, Clinical Trials and Innovation and Director, Inpatient Dermatology, Brigham and Women's Hospital. "As a dermatologist, I find these data particularly encouraging because it addresses the physical effects of hair loss, which can, in turn, address the significant emotional and mental health challenges that patients often face."
Additionally, 12 poster presentations will underscore the clinical efficacy and safety of ILUMYA® (tildrakizumab) in moderate-to-severe plaque psoriasis. These data also include research from interim data analysis from real-world settings.
The following abstracts representing the dermatology portfolio will be presented at the 33rd EADV Congress:
Deuruxolitinib
Podium Presentation [FC04.04]: Change in patient-reported hair satisfaction during deuruxolitinib treatment of severe alopecia areata: Pooled data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 trials (Presentation Time: September 26 at 16:30-16:40)
Poster Presentation [P2022]: Improvement in anxiety and depression in adult patients with severe alopecia areata treated with deuruxolitinib: Pooled data from the THRIVE-AA1 and THRIVE-AA2 Phase 3 trials
Poster Presentation [P2081]: Optimization of deuruxolitinib dosing in adult patients with alopecia areata: Results from a randomized, parallel-group, multicenter, Phase 2 trial
Tildrakizumab
Poster Presentation [P3221]: Comparative Efficacy and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis: Systematic Literature Review (SLR) and Network Meta-Analysis (NMA)
Poster Presentation
[P3177]: Efficacy and safety of tildrakizumab through Week 28 in patients with early vs late-onset moderate-to-severe plaque psoriasis: A post hoc analysis of reSURFACE 1 and reSURFACE 2
Poster Presentation
[P3274]: Improving the well-being of patients with moderate to severe plaque psoriasis and involvement of impactful areas with Tildrakizumab*
Poster Presentation
[P3348]: Effectiveness and Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) of tildrakizumab patients with nail psoriasis: 52-week results from the phase IV POSITIVE Austrian subset*
Poster Presentation
[P3343]: Effectiveness of tildrakizumab in patients with moderate-to-severe psoriasis located in special areas: 52-week results from the POSITIVE study*
Poster Presentation
[P3341]: High effectiveness of tildrakizumab in bio-naïve and bio-experienced patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study*
Poster Presentation
[P3340]: High effectiveness of tildrakizumab regardless of baseline characteristics in patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study*
Poster Presentation
[P3188]: Patient-reported well-being using tildrakizumab for psoriasis in a real-world setting: 52-week interim data of the phase IV POSITIVE study*
Poster Presentation [P3339]: Safety of tildrakizumab in patients with moderate-to-severe psoriasis: 52-week data from the phase IV POSITIVE study*
Poster Presentation
[P3346]: Effectiveness of tildrakizumab for itch, pain, and fatigue in patients with moderate-to-severe psoriasis: 52-week results from the real-world POSITIVE study*
Poster Presentation
[P3347]: Quality of life, work productivity and treatment satisfaction with tildrakizumab in moderate-to-severe psoriasis patients: 52-week interim data of the real-world POSITIVE study*
Poster Presentation
[P3344]: (ENCORE) Impact of patient psoriasis on partner well-being in a real-world setting: 52- week interim data of the phase IV POSITIVE study*
* Indicates data sponsored by Almirall; Sun Pharma and Almirall operate under a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe
About LEQSELVI™ and alopecia areata
LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adult patients with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime.2,3,4 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata.
About THRIVE-AA1 and THRIVE-AA2 trial design
THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650) were randomized, double-blind, placebo-controlled clinical trials in 1223 adult patients ages 18-65 with severe alopecia areata at sites in the U.S., Canada and Europe evaluating the regrowth of scalp hair after 24 weeks of dosing using the Severity of Alopecia Tool (SALT) score. Patients were randomized to receive either 8 mg twice daily or 12 mg twice daily of deuruxolitinib or placebo for 24 weeks. The primary endpoint was the percentage of patients achieving a SALT score of 20 or less at 24 weeks. Patients enrolled in THRIVE-AA1 and THRIVE-AA2 were required to have at least 50 percent scalp hair loss due to alopecia areata, as measured by SALT. A SALT score of 100 represents total scalp hair loss, whereas a score of 0 represents no scalp hair loss. The average baseline SALT score across all patients in THRIVE-AA1 and THRIVE-AA2 was approximately 85.9 and 87.9 respectively.
LEQSELVI Important Safety Information
Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide.
Indications and Usage
LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata.
Limitations of Use
LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Contraindications
LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors.
Warnings
Serious Infections
Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
Mortality
Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients.
Malignancy
Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients.
Major Adverse Cardiovascular Events
Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients.
Thrombosis
Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers.
Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors
Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI.
Gastrointestinal Perforations
GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms.
Lipid elevations, anemia, neutropenia, and lymphopenia
Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes.
Immunizations
Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations.
Dosage
The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food.
Before treatment with LEQSELVI, perform the following evaluations:
CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors;
Active and latent tuberculosis evaluation;
Viral hepatitis screening;
Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl).
Adverse Reactions
Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes.
Use in Specific Populations
Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose.
LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment.
ILUMYA Important Safety Information
Please click here for Full Prescribing Information and Medication Guide.
INDICATION
ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
CONTRAINDICATIONS
ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS:
Hypersensitivity: Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.
Infections: ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves.
Pretreatment Evaluation for Tuberculosis: Evaluate patients for tuberculosis (TB ) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment.
Immunizations: Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines.
Adverse Reactions: The most common (≥1 % ) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea.
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or
.
Disclaimer
Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof.
References
Cleveland Clinic. Alopecia Areata. .
Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States, Clinical, Cosmetic and Investigational Dermatology 2020.
Lee HH et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis, J Am Acad Dermatol. 2020 Mar; 82(3): 675-682.
Fricke et al. Epidemiology and burden of alopecia areata: a systematic review, Clin Cosmet Investig Dermatol. 2015 Jul 24;8: 397-403.
About Sun Pharmaceutical Industries Limited. (CIN - L24230GJ1993PLC019050)
Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter).
Contacts: Sun Pharma
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临床结果临床3期上市批准临床2期引进/卖出
2024-09-25
New post-hoc analysis demonstrated efficacy of RINVOQ® (upadacitinib) in moderate-to-severe atopic dermatitis patients with varying degrees of severity in head and neck involvement, with results in skin clearance, itch resolution and impact on quality of life at 16 weeks1
Atopic dermatitis in the head and neck regions can have a significant impact on the quality of life for patients and is highly prevalent based on real-world observational studies2-4
New data showcasing depth and strength across AbbVie's dermatology portfolio will be presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam
NORTH CHICAGO, Ill., Sept. 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from a new post-hoc analysis from the Measure Up 1 and Measure Up 2 Phase 3 studies. The analysis evaluated the efficacy of upadacitinib (15 mg or 30 mg) in patients with moderate-to-severe atopic dermatitis (AD) stratified by the severity of disease in the head and neck region at baseline compared to placebo across 16 weeks.1
In this analysis, several optimal and stringent treatment targets – including the achievement of near complete skin clearance in the head and neck region (EASI Head & Neck score <1), near complete skin clearance (EASI 90), no to little itch (WP-NRS 0/1) and minimal or no impact on quality of life (DLQI 0/1) – were assessed with the treatment of upadacitinib across patient subgroups. Patients were stratified by no-to-mild, moderate, or severe head and neck involvement.1
Living with uncontrolled AD can have a substantial physical, emotional and social impact on patients' lives and is often associated with significant long-term disease burden from debilitating symptoms.5 Research shows that AD in specific sites such as the head, neck, face and hands can have a significant impact on symptom frequency and quality of life for patients.2,6 In the real-world observational setting, 70% of AD patients in the UP-TAINED study and at least 74.5% of AD patients in the AD-VISE study had head and neck region involvement at baseline.3,4 The high prevalence reinforces the need for effective therapies in this high impact, challenging to treat area.
"These data stratify the severity of atopic dermatitis in the head and neck region, which is a part of the body that has significant impact on patients and is challenging to treat," said Kilian Eyerich, MD, PhD, chair and professor at the Department of Dermatology and Venerology of the University of Freiburg, Germany. "At 16 weeks, RINVOQ showed efficacy in patients with moderate-to-severe atopic dermatitis with various degrees of head and neck involvement, achieving optimal treatment targets with combined measures of EASI 90 and WP-NRS 0/1, along with improvement on the patients' quality of life measured by DLQI 0/1 in a substantial number of patients."
New post-hoc analysis of the Measure Up 1 and Measure Up 2 studies showed that a higher proportion of patients with moderate-to-severe AD with varying degrees of head and neck involvement treated with upadacitinib (15 mg or 30 mg) achieved the following optimal treatment targets compared to placebo at week 16: near complete skin clearance in the head and neck region (EASI Head & Neck Score <1), minimal or no impact on quality of life (DLQI 0/1), and minimal disease activity, which is the simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1)1:
Primary efficacy and safety results from these ongoing pivotal studies have been previously reported: .
"Despite taking steps to manage their condition, many patients with atopic dermatitis continue to live with debilitating symptoms, especially in highly visible areas such as head and neck that can intensify one's physical and emotional burden," said Andrew Anisfeld, PhD, vice president, global medical affairs, immunology, AbbVie. "These data contribute to our ongoing commitment to elevate the standard of care in atopic dermatitis so patients can strive for the best possible outcomes."
Additional abstracts to be presented at EADV 2024 supporting the efficacy and safety profile of RINVOQ (upadacitinib) for moderate-to-severe AD include:
Efficacy and safety of upadacitinib vs dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (LEVEL UP): This study evaluated the efficacy and safety of RINVOQ (15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (per its labeled dose) in adults and adolescents (≥12 years of age) with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when use of those therapies was inadvisable. The primary endpoint was achievement of both EASI 90 and WP-NRS 0/1 at Week 16.7
FC08.04 Oral Presentation on Friday, 27 September 2024, 16:30-16:40
Effectiveness of upadacitinib in adults and adolescents with atopic dermatitis: 6-month interim analysis of the real-world multicountry AD-VISE study: An interim analysis of the AD-VISE study evaluating the effectiveness and durability of response to upadacitinib for skin clearance (EASI) and itch resolution (WP-NRS) in real-world settings. Results include 578 adult and adolescent patients with moderate-to-severe AD treated with upadacitinib (15 mg or 30 mg).3
P0683 E-Poster
Baseline criteria from a real world non-interventional study with Upadacitinib for the treatment of systemic atopic dermatitis: an analysis based on guideline criteria (UP-TAINED): An interim analysis of the UP-TAINED study including baseline visit data from 351 patients with moderate-to-severe AD treated with upadacitinib in real-world settings in Germany. Results show that patients treated with upadacitinib met German checklist criteria for systemic therapy.4
P0535 E-Poster
About Atopic Dermatitis
Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching leading to cracked, scaly, oozing skin.8,9 It affects up to an estimated 10% of adults and 24.6% of adolescents.9-11 Between 20% and 46% of adults with atopic dermatitis have moderate-to-severe disease.12 The range of symptoms poses significant physical, psychological and economic burden on individuals impacted by the disease.9,13
About Measure Up 1 and Measure Up 2
Measure Up 1 and Measure Up 2 are Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled studies designed to evaluate the safety and efficacy of RINVOQ in adult and adolescent (12 years or older) patients with moderate to severe atopic dermatitis who are candidates for systemic treatment. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo. The co-primary endpoints were the percentage of patients achieving EASI 75 and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 after 16 weeks of treatment. Patients receiving placebo were switched to either RINVOQ 15 mg or RINVOQ 30 mg at week 16.14,15
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.16
Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.17-22
EU Indications and Important Safety Information about RINVOQ® (upadacitinib)23
Indications
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.
Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Crohn's disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Important Safety Information
Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.
Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:
65 years of age and older;
patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);
patients with malignancy risk factors (e.g. current malignancy or history of malignancy)
Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another JAK inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.
Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.
Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.
Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.
Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.
Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.
Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active‑controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.
Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.
Gastrointestinal Perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.
Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.
Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.
Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.
Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose‑dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.
Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.
Hypoglycemia in patients treated for diabetes
There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs.
Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.
The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg in adolescents was similar to that in adults. The safety and efficacy of the 30 mg dose in adolescents are still being investigated.
The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.
The most common serious adverse reactions were serious infections.
The safety profile of RINVOQ with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications.
This is not a complete summary of all safety information.
See RINVOQ full Summary of Product Characteristics (SmPC) at
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
References:
Eyerich K, Mendes-Bastos P, Holzer G, et al. Efficacy of upadacitinib in treating atopic dermatitis in the head and neck regions. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. ePoster P0734.
Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-C347. doi:10.1016/j.anai.2018.07.006
Gooderham MJ, Pereyra-Rodriguez JJ, Sinclair R, et al. Effectiveness of upadacitinib in adults and adolescents with atopic dermatitis: 6-month interim analysis of the real-world multicountry AD-VISE study. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. ePoster P0683.
Weidinger S, Pinter A, Weyergraf T, et al. Baseline criteria from a real world non-interventional study with upadacitinib for the treatment of systemic atopic dermatitis: an analysis based on guideline criteria. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. ePoster P0535.
Wollenberg A, Gooderham M, Katoh N, et al. Patient-reported burden in adults with atopic dermatitis: an international qualitative study. Arch Dermatol Res. 2024;316(7):380. doi:10.1007/s00403-024-03130-w
Hang L, Aroman MS, Taieb C, et al. The impact of eczema involving visible areas of the skin on patients' quality of life. JEADV Clin Pract. 2022;1:105-110. doi:10.1002/jvc2.20
Silverberg JI, Bunick C, Hong HC, et al. Efficacy and safety of upadacitinib vs dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (Level Up). Paper presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. FC08.04.
Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(suppl 1):8-16. doi:10.1159/000370220
Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine A. Atopic dermatitis. Nat Rev Dis Primers. 2018;4(1):1. doi:10.1038/s41572-018-0001-z
Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44-56. doi:10.1001/jamadermatol.2019.3336
Blauvelt A, Guttman-Yassky E, Paller AS, et al. Long-term efficacy and safety of dupilumab in adolescents with moderate-to-severe atopic dermatitis: results through week 52 from a phase III open-label extension trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022;23(3):365-383. doi:10.1007/s40257-022-00683-2
Shrestha S, Miao R, Wang L, Chao J, Yuce H, Wei W. Burden of atopic dermatitis in the United States: analysis of healthcare claims data in the commercial, Medicare, and Medi-Cal databases. Adv Ther. 2017;34(8):1989-2006. doi:10.1007/s12325-017-0582-z
European Federation of Allergy and Airways Diseases Patients' Associations. Atopic eczema: itching for life report—quality of life and costs for people with severe atopic eczema in Europe. Published July 2018. Accessed August 28, 2023.
Evaluation of upadacitinib in adolescent and adult patients with moderate to severe atopic dermatitis (eczema) (Measure Up 1). ClinicalTrials.gov identifier: NCT03569293. Updated March 5, 2024. Accessed April 9, 2024.
A study to evaluate upadacitinib in adolescents and adults with moderate to severe atopic dermatitis (Measure Up 2). ClinicalTrials.gov identifier: NCT03607422. Updated March 5, 2024. Accessed April 9, 2024.
RINVOQ. Summary of product characteristics. AbbVie. Accessed September 19, 2024.
A study to evaluate the safety and effectiveness of upadacitinib tablets in adult and adolescent participants with severe alopecia areata (Up-AA). ClinicalTrials.gov identifier: NCT06012240. Updated September 19, 2024. Accessed September 19, 2024.
A study to evaluate the safety and efficacy of upadacitinib in participants with giant cell arteritis (SELECT-GCA). ClinicalTrials.gov identifier: NCT03725202. Updated February 23, 2024. Accessed September 19, 2024.
A study to assess change in disease activity and adverse events of oral upadacitinib in adult and adolescent participants with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy (Step-Up HS). ClinicalTrials.gov identifier: NCT05889182. Updated August 29, 2024. Accessed April 9, 2024.
A study to evaluate the efficacy and safety of upadacitinib in participants with Takayasu arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov identifier: NCT04161898. Updated March 22, 2024. Accessed April 9, 2024.
Program to assess adverse events and change in disease activity of oral upadacitinib in adult participants with moderate to severe systemic lupus erythematosus (SELECT-SLE). ClinicalTrials.gov identifier: NCT05843643. Updated September 19, 2024. Accessed April 9, 2024.
A study to assess adverse events and effectiveness of upadacitinib oral tablets in adult and adolescent participants with vitiligo (Viti-Up). ClinicalTrials.gov identifier: NCT06118411. Updated March 28, 2024. Accessed April 9, 2024.
RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2024.
SOURCE AbbVie
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 附着点炎相关关节炎 | 欧盟 | 2023-09-21 | |
| 附着点炎相关关节炎 | 冰岛 | 2023-09-21 | |
| 附着点炎相关关节炎 | 列支敦士登 | 2023-09-21 | |
| 附着点炎相关关节炎 | 挪威 | 2023-09-21 | |
| 幼年特发性关节炎 | 欧盟 | 2023-09-21 | |
| 幼年特发性关节炎 | 冰岛 | 2023-09-21 | |
| 幼年特发性关节炎 | 列支敦士登 | 2023-09-21 | |
| 幼年特发性关节炎 | 挪威 | 2023-09-21 | |
| 少关节关节炎 | 欧盟 | 2023-09-21 | |
| 少关节关节炎 | 冰岛 | 2023-09-21 | |
| 少关节关节炎 | 列支敦士登 | 2023-09-21 | |
| 少关节关节炎 | 挪威 | 2023-09-21 | |
| 多关节型幼年特发性关节炎 | 欧盟 | 2023-09-21 | |
| 多关节型幼年特发性关节炎 | 冰岛 | 2023-09-21 | |
| 多关节型幼年特发性关节炎 | 列支敦士登 | 2023-09-21 | |
| 多关节型幼年特发性关节炎 | 挪威 | 2023-09-21 | |
| 新型冠状病毒感染 | 瑞士 | 2017-06-19 | |
| 斑秃 | 欧盟 | 2017-02-13 | |
| 斑秃 | 冰岛 | 2017-02-13 | |
| 斑秃 | 列支敦士登 | 2017-02-13 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| Aicardi-Goutieres综合征 | 临床3期 | 日本 | 2020-10-27 | |
| 慢性非典型中性粒细胞性皮肤病伴脂肪营养不良和体温升高 | 临床3期 | 日本 | 2020-10-27 | |
| 肢骨纹状肥大 | 临床3期 | 日本 | 2020-10-27 | |
| Nakajo综合征 | 临床3期 | 日本 | 2020-10-27 | |
| 婴儿期发病的STING相关血管病变 | 临床3期 | 日本 | 2020-10-27 | |
| 全身型幼年特发性关节炎 | 临床3期 | 日本 | 2020-02-12 | |
| 全身型幼年特发性关节炎 | 临床3期 | 阿根廷 | 2020-02-12 | |
| 全身型幼年特发性关节炎 | 临床3期 | 奥地利 | 2020-02-12 | |
| 全身型幼年特发性关节炎 | 临床3期 | 比利时 | 2020-02-12 | |
| 全身型幼年特发性关节炎 | 临床3期 | 巴西 | 2020-02-12 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | 30 | (Baricitinib) | 衊壓製鏇夢獵襯顧繭窪(廠築衊遞衊艱觸壓壓選) = 鏇蓋顧壓範範積築簾餘 網壓醖顧選鬱製鹹顧範 (鹹簾構鑰鏇選繭淵廠顧, 遞觸餘廠壓鏇鑰顧襯繭 ~ 窪鹹製積糧齋築鏇願齋) 更多 | - | 2024-08-13 | ||
(Adalimumab) | 餘觸餘壓衊遞鬱觸壓構(鹹觸齋範鏇簾製醖淵憲) = 網艱鬱製積網襯築觸齋 膚壓醖製憲醖壓觸築艱 (襯製構淵觸製襯鑰鬱獵, 願觸壓鏇觸網蓋鬱艱築 ~ 繭蓋繭襯顧鏇簾構壓夢) 更多 | ||||||
临床3期 | 131 | 繭製鏇窪蓋築淵餘餘蓋(選蓋願顧襯壓糧鏇憲構) = progressive improvements 範繭壓範壓鹽網夢選遞 (構積觸繭鹹鏇醖構觸構 ) 更多 | 积极 | 2024-06-21 | |||
临床2期 | 12 | (Cutaneous LP) | 鹽獵鬱淵繭簾淵顧顧遞(簾淵齋齋構繭廠蓋餘衊) = 鏇糧選衊醖糧壓簾醖觸 選鹽獵醖餘餘獵糧獵範 (窪觸糧窪憲繭網選憲製, 積顧選壓餘餘選獵鬱積 ~ 築鹽觸範構範壓壓蓋餘) 更多 | - | 2024-06-11 | ||
(Dose Escalation Extension Group) | 廠窪築簾簾繭鹹壓廠窪(壓餘淵淵鏇壓網夢選壓) = 選繭餘糧壓窪齋齋選膚 鬱鬱餘餘簾網衊願蓋襯 (夢觸願壓鏇觸簾鹹艱艱, 壓餘選齋艱顧鏇築鏇製 ~ 繭構夢醖鹽選窪壓鹹構) 更多 | ||||||
EULAR2024 人工标引  | N/A | 60 | 鹽獵顧膚壓淵遞壓夢廠(壓鑰艱襯簾壓願蓋觸糧) = 糧夢觸鹹襯鏇餘餘壓製 範衊遞齋製糧鏇構醖積 (繭窪觸蓋鑰網鏇願顧餘 ) 更多 | 积极 | 2024-06-05 | ||
N/A | 673 | 壓觸觸膚製鹽選壓獵淵(選壓淵鑰網簾糧艱築選) = 範廠築築廠衊壓襯齋窪 糧選積繭膚顧廠製膚壓 (積網醖鏇鑰製製廠糧範 ) 更多 | 积极 | 2024-06-05 | |||
Tumor Necrosis Factor Inhibitor | 壓觸觸膚製鹽選壓獵淵(選壓淵鑰網簾糧艱築選) = 鏇糧繭繭憲積簾壓獵壓 糧選積繭膚顧廠製膚壓 (積網醖鏇鑰製製廠糧範 ) 更多 | ||||||
N/A | 18 | 獵獵鏇顧淵艱夢壓衊夢(壓壓淵衊鑰窪鏇築衊壓) = 襯製艱淵構鹽膚醖蓋襯 築獵壓淵築餘鹽鏇窪範 (艱糧範鑰選窪醖觸淵網 ) | 积极 | 2024-06-05 | |||
(Healthy controls) | 獵獵鏇顧淵艱夢壓衊夢(壓壓淵衊鑰窪鏇築衊壓) = 鏇憲顧鏇窪範築觸艱範 築獵壓淵築餘鹽鏇窪範 (艱糧範鑰選窪醖觸淵網 ) | ||||||
N/A | 219 | 醖願範夢簾夢範襯鬱網(鑰壓衊顧觸獵範齋鹹鹹) = No new safety issues were detected during this period of observation 鬱顧鏇齋獵願鑰遞網獵 (鑰蓋餘積選築窪淵簾夢 ) 更多 | 积极 | 2024-06-05 | |||
Baricitinib and methotrexate combination therapy | |||||||
N/A | 类风湿关节炎 CGRP | 43 | 廠製製範範鑰夢膚艱選(膚獵淵獵觸廠鬱夢淵遞) = 遞艱積築鑰艱鹹憲獵製 顧簾構製繭襯獵夢簾顧 (醖蓋夢遞蓋窪築觸糧積 ) | 积极 | 2024-06-05 | ||
(Responder patients) | 廠製製範範鑰夢膚艱選(膚獵淵獵觸廠鬱夢淵遞) = 醖壓醖積鏇鹽鑰餘夢鹽 顧簾構製繭襯獵夢簾顧 (醖蓋夢遞蓋窪築觸糧積 ) | ||||||
临床3期 | 546 | Placebo (Placebo) | 獵齋夢觸窪鹹網淵簾選(餘艱鑰簾衊夢夢簾餘願) = 窪築窪遞繭淵繭構鑰憲 鹹衊齋繭遞淵範鏇簾淵 (襯鹹遞衊憲選築艱艱蓋, 積窪網選艱憲齋憲艱夢 ~ 醖遞願糧選夢廠簾齋築) 更多 | - | 2024-05-14 | ||
Placebo+Baricitinib (2 mg Baricitinib) | 獵齋夢觸窪鹹網淵簾選(餘艱鑰簾衊夢夢簾餘願) = 獵襯衊淵餘廠憲積鏇餘 鹹衊齋繭遞淵範鏇簾淵 (襯鹹遞衊憲選築艱艱蓋, 構選願鹹齋顧獵蓋壓製 ~ 壓築壓遞範淵觸鏇窪範) 更多 | ||||||
临床2期 | 扁平苔藓 IFN-γ | CD8+ | CXCL13+ | - | 鹽鏇艱鑰遞夢壓齋齋艱(廠獵鏇觸蓋選製構積願) = 範繭襯鹽鬱鏇襯遞鹹夢 窪願淵廠選願窪網壓範 (鬱鹹窪製選憲鏇壓淵窪 ) | 积极 | 2024-01-11 |
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