Upadacitinib hemihydrate

Immunology In two replicate Phase 3 studies, upadacitinib (RINVOQ®) achieved the co-primary endpoints of 50% reduction in Total Vitiligo Area Scoring Index (T-VASI 50) from baseline and 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 481 Both studies met key ranked secondary endpoints1 NORTH CHICAGO, Ill., Oct. 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from two replicate Phase 3 studies evaluating the safety and efficacy of upadacitinib (RINVOQ®;15 mg, once daily in adult and adolescent patients living with non-segmental vitiligo (NSV).1 NSV, the most common form of vitiligo (occurring in over 90% of patients), is characterized by symmetrical and bilateral white patches on both sides of the body.2-4 "Vitiligo is more than a skin condition – it's a chronic autoimmune disease that can deeply affect a person's confidence, identity and daily life," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "There are no approved systemic medical therapies for achieving re-pigmentation in vitiligo. These Phase 3 results represent a significant milestone in AbbVie's commitment to supporting patients and expanding our immunology portfolio to deliver innovative solutions." The Total Vitiligo Area Scoring Index (T-VASI) is a tool that measures the extent of de-pigmentation over the entire body while F-VASI measures de-pigmentation of the face, an area among the most visible and psychosocially impactful for people living with NSV. Across both studies approximately 70% of subjects had T-VASI > 10 at baseline. In both studies, upadacitinib achieved the co-primary endpoints of T-VASI 50 (≥50% reduction from baseline in T-VASI score) and F-VASI 75 (≥75% reduction from baseline in F-VASI score) at week 48 versus placebo. Across both studies, statistically significant differences were observed with upadacitinib versus placebo in key ranked secondary endpoints, including F-VASI 50 at week 48.1 Key efficacy results are summarized below: Phase 3 Efficacy Results1 Study 1 Study 2 Upadacitinib 15 mg (N=206), % Placebo (N=102), % Upadacitinib 15 mg (N=205), % Placebo (N=101), % Co-Primary Endpoints T-VASI 50 at week 48 19.4 5.9 21.5 5.9 F-VASI 75 at week 48 25.2 5.9 23.4 6.9 Secondary Endpoints F-VASI 50 at week 48 48.1 12.7 43.4 12.9 "For many people living with vitiligo, the journey is marked by uncertainty, frustration and a lack of medicines that can treat the disease systemically," said Thierry Passeron, M.D., Ph.D., professor and chair, Department of Dermatology, Université Côte d'Azur. "These positive results indicate that targeting the underlying inflammation may offer a systemic treatment option which could help patients achieve visible results." The safety profile of upadacitinib in both studies was generally consistent with that observed in approved indications. No new safety signals were observed. Across both studies, the most frequent treatment-emergent adverse events (TEAEs) in the 48 weeks upadacitinib treatment groups were upper respiratory tract infection, acne and nasopharyngitis. In study 1, treatment-emergent serious adverse events (TESAEs) occurred in 3.9% and 4% of patients in the upadacitinib 15 mg and placebo groups, respectively. In study 2, TESAEs occurred in 2% and 1% of patients in the upadacitinib 15 mg and placebo groups, respectively. There were no adjudicated cases of any major cardiovascular event (MACE) or venous thromboembolism (VTE) in the studies. Three malignancy events were reported: one was reported in both placebo groups (1% each) of studies 1 and 2, and one was reported in the upadacitinib 15 mg group (0.5%) in study 1 (genital neoplasm). There were no deaths reported in the upadacitinib treated groups across both studies. There was one death reported in the placebo group in study 2.1 Use of upadacitinib in NSV is not approved and its safety and efficacy have not been evaluated by regulatory authorities. About Vitiligo Vitiligo is a chronic autoimmune disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches of skin that can appear anywhere on the body and at any time. It is the most common depigmenting disorder worldwide, affecting approximately 0.5% to 2.3% of the global population. Non-segmental vitiligo (NSV) is the predominant form of the disease, accounting for roughly 84% of cases. NSV typically presents as symmetrical, bilateral patches on both sides of the body. While location varies, many patients report patches on critical areas such as the face, feet, hands and groin. The daily challenges of living with vitiligo can lead to mental health conditions, with a high prevalence of depression and anxiety. About Viti-Up Clinical Trials Upadacitinib M19-044 was conducted under a single protocol encompassing two replicate Phase 3 studies (Study 1 and Study 2) with independent randomization, investigative sites, data collection, analysis and reporting for each study. The trials were designed to evaluate the efficacy, safety and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) living with non-segmental vitiligo (NSV) who were eligible for systemic therapy. In Period A of both studies, participants were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo for 48 weeks. Participants who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all patients received upadacitinib 15 mg once daily. In total, Study 1 and Study 2 Periods A and B span 160 weeks. The two trials randomized 614 participants with NSV across 90 sites worldwide. More information on these trials can be found at www.clinicaltrials.gov (NCT06118411). The co-primary endpoints were based on the achievement of Total Vitiligo Area Scoring Index (T-VASI) 50, defined as at least 50% reduction in T-VASI from baseline, at week 48, and the achievement of Facial Vitiligo Area Scoring Index (F-VASI) 75, defined as at least 75% reduction in F-VASI from baseline, at week 48 with the treatment of upadacitinib 15 mg compared with placebo in adults and adolescents with NSV. The secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, and the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24. These endpoints were designed to assess the degree and timing of re-pigmentation on the face, an area among the most visible and psychosocially impactful for people living with NSV. Study 1 also included an analysis using 3D digital imaging to assess facial repigmentation, measured in a subset of the study population. About RINVOQ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo. RINVOQ (upadacitinib) U.S. Uses and Important Safety Information5 RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated. Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated. Adults with giant cell arteritis (GCA). Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers. Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers. It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis. It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis. RINVOQ/RINVOQ LQ is a prescription medicine used to treat: Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Children 2 to less than 18 years of age with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis. IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib) What is the most important information I should know about RINVOQ*? RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster). Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker. Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor. Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away. Tears in the stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting. Changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results. Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. What should I tell my HCP BEFORE starting RINVOQ? Tell your HCP if you: Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection, such as: ̶ Fever, sweating, or chills ̶ Shortness of breath ̶ Warm, red, or painful skin or sores on your body ̶ Muscle aches ̶ Feeling tired ̶ Blood in phlegm ̶ Diarrhea or stomach pain ̶ Cough ̶ Weight loss ̶ Burning when urinating or urinating more often than normal Have TB or have been in close contact with someone with TB. Are a current or past smoker. Have had a heart attack, other heart problems, or stroke. Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines. Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP. Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose. There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110. Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects. Especially tell your HCP if you take: Medicines for fungal or bacterial infections Rifampicin or phenytoin Medicines that affect your immune system If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist. What should I avoid while taking RINVOQ? Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects. What should I do or tell my HCP AFTER starting RINVOQ? Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw Pain or discomfort in your arms, back, neck, jaw, or stomach Shortness of breath with or without chest discomfort Breaking out in a cold sweat Nausea or vomiting Feeling lightheaded Weaknesses in one part or on one side of your body Slurred speech Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including: Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw Pain or discomfort in your arms, back, neck, jaw, or stomach Shortness of breath with or without chest discomfort Breaking out in a cold sweat Nausea or vomiting Feeling lightheaded Weaknesses in one part or on one side of your body Slurred speech ̶ Swelling ̶ Pain or tenderness in one or both legs ̶ Sudden unexplained chest or upper back pain ̶ Shortness of breath or difficulty breathing Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits. What are other possible side effects of RINVOQ? Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, swelling of the feet and hands (peripheral edema), increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis). A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ. Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your HCP. These are not all the possible side effects of RINVOQ. How should I take RINVOQ/RINVOQ LQ? RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP. *Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ. This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide. 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 including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. 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, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. 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 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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: Contacts: Media: Investors: Sourojit (Jit) Bhowmick, Ph.D. Liz Shea jit.bhowmick@abbvie.com liz.shea@abbvie.com SOURCE AbbVie

特应性皮炎外用治疗与管理专家共识（2025版） 《特应性皮炎外用治疗与管理专家共识（2025版）》编写专家组 通信作者：张建中，Email：rmzjz@126.com 【引用本文】  《特应性皮炎外用治疗与管理专家共识（版）》编写专家组.  特应性皮炎外用治疗与管理专家共识（2025版）[J]. 中华皮肤科杂志, 2025,58(10):903-909. doi:10.35541/cjd.20250247 【摘要】    外用药物是特应性皮炎（AD） 治疗的核心基础，规范应用对于优化疗效、降低不良反应发生至关重要。本共识由多学科专家团队基于AD循证医学证据、国内外指南及专家临床经验，紧密结合中国AD患者疾病特征编写。内容系统梳理经典和新兴外用药物的应用原则，强调阶梯治疗与主动维持治疗的策略，针对特殊部位、特殊人群制定具体用药方案。该共识旨在为临床医师提供系统化、科学化、规范化的用药指导，提升AD整体管理水平。 【关键词】    皮炎，特应性；治疗；外用药物；维持治疗；特殊部位；共识   DOI：10.35541/cjd.20250247 Expert consensus on the topical treatment and management of atopic dermatitis （2025 edition） The Expert Panel for the “Expert Consensus on the Topical Treatment and Management of Atopic Dermatitis（2025 edition）” Corresponding author: Zhang Jianzhong, Email: rmzjz@126.com 【Abstract】   Topical medications form the cornerstone of atopic dermatitis （AD） treatment, and their standardized application is crucial for optimizing therapeutic efficacy and reducing the incidence of adverse reactions. Developed by a multidisciplinary expert team, this consensus is meticulously crafted based on evidence-based medicine for AD, Chinese and international guidelines, and expert clinical experience, and is closely tailored to the disease characteristics of Chinese AD patients. The consensus systematically outlines the application principles of classic and emerging topical agents, emphasizes strategies of stepwise therapy and proactive maintenance treatment, and establishes specific medication protocols for special anatomical sites and vulnerable populations. Aiming to provide clinicians with systematic, scientific, and standardized medication guidance, this consensus seeks to enhance the overall management of AD. 【Key words】   Dermatitis, atopic; Therapy; Topical treatment; Maintenance treatment; Special sites; Consensus DOI: 10.35541/cjd.20250247 特应性皮炎（atopic dermatitis，AD），也称特应性湿疹（atopic eczema），是一种慢性复发性、炎症性、瘙痒性皮肤病[1]。AD发病与多种因素相关，包括遗传易感性、皮肤屏障功能障碍、免疫失调、皮肤微生物菌群失调等[2]。AD可累及各个年龄段人群[3]。儿童AD的发病率和患病率比成人高[4]，在发达国家，成人和儿童的AD患病率分别为7%~14%和20%[5]。我国成人AD患病率3% ~ 8%，儿童10% ~ 15%，AD的疾病负担在非致命性皮肤病中排首位[3，6]。外用药物是AD的重要治疗手段，正确规范的外用治疗对于提高疗效、减少不良反应十分重要。 本共识由皮肤科、变态反应科、儿科、药学等32位多学科领域专家组成编写专家组，进行证据检索、共识框架搭建和内容撰写。系统检索PubMed、Embase、中国知网、万方数据库等文献数据库，同时检索权威指南发布平台，包括美国皮肤病学会、英国国家临床优化研究所、欧洲皮肤病论坛等。检索时间为建库至共识编写完成前（2025年4月）。限定语种为英文或中文。英文检索词包括“AD、topical treatment、proactive maintenance treatment、TCS、TCI、PDE-4 inhibitors、AHR modulators、JAK inhibitors”等；中文检索词包括“特应性皮炎、外用药、主动维持治疗、外用糖皮质激素、钙调磷酸酶抑制剂、磷酸二酯酶4抑制剂、芳香烃受体调节剂、Janus激酶抑制剂”等。通过筛选，最终纳入符合本共识编写要求的相关文献65篇，为AD外用治疗与管理的规范化建议提供证据支撑。编写组基于检索资料，草拟本共识框架并基于该框架完成初稿撰写。编写组邀请共识专家组经过1轮线上研讨会、2轮线上问卷投票，对共识内容进行了4轮修改形成最终正文。根据预先设定的标准，达到70%以上的专家意见一致被定义为达成共识。本共识重点关注中国人群的研究数据，旨在为临床提供更贴合国人疾病特征的用药指导，使AD治疗更科学、更规范。 一、 常用外用药及其应用 1. 糖皮质激素：一线抗炎治疗药物。外用糖皮质激素（TCS）制剂的亲脂性和低分子量使其能够很好地渗透到皮肤并与细胞质中的类固醇受体结合。皮质类固醇受体复合物作为转录因子具有双重活性，降低促炎性细胞因子的合成，增加抗炎介质的合成。 TCS适用于所有AD患者。因不同的体表部位外用药物吸收差异较大[7]，如薄嫩部位药物吸收多，不建议使用强效或超强效糖皮质激素（见本文“特殊部位用药”）。TCS可以按照指尖单位法则使用：从管口内径5 mm的药管中挤出长度从食指指尖至远端指间关节横线，约0.5 g，可用于2个手掌大小面积。 根据Niedner分类[1]，TCS可根据药效强度分为4级，见表1。 AD外用治疗的早期（诱导治疗阶段）可短期使用强效或超强效TCS，以控制皮损，有利于延长缓解时间和降低复发风险[8-10]。一般情况下，超强效和强效TCS连续用药不超过2周。儿童推荐使用中弱效TCS，建议连续用药不超过4 ~ 6周，皮疹控制后进入治疗维持期，可逐渐由强效TCS过渡到中弱效TCS，再过渡到钙调磷酸酶抑制剂（TCI）。在外用维持治疗阶段可选择主动维持治疗，具体用法请参见本文“外用药物的应用原则”。 TCS常见的局部不良反应包括皮肤萎缩、毛细血管扩张、膨胀纹和多毛症等，大多数不良反应可在停药或对症治疗后缓解，但膨胀纹难以恢复[11-13]。在皮肤薄嫩部位，若长期使用强效或超强效TCS，可增加局部不良反应发生风险。若需长期大面积使用 TCS 或用于薄嫩部位，有条件时可进行肾上腺功能抑制监测[11]。 2. TCI：通过抑制钙调磷酸酶的活性，抑制T淋巴细胞的活化，从而抑制AD的免疫反应，达到治疗作用。大型临床试验[14-15]已证实外用吡美莫司和他克莫司的短期和长期疗效。1%吡美莫司乳膏、0.1%和0.03%他克莫司软膏已在我国获批用于AD的治疗。与TCS相比，TCI经表皮渗透性较低，无TCS的不良反应。 0.1%他克莫司软膏适用于16岁及以上的患者，0.03%他克莫司软膏适用于2岁以上儿童患者。吡美莫司乳膏适用于3个月及以上婴幼儿及儿童，是国内首个批准用于婴幼儿AD的非糖皮质激素类外用药物，2022年欧洲AD治疗指南[10]也推荐用于3月龄及以上婴幼儿AD的治疗。TCI没有皮肤萎缩、毛细血管扩张等不良反应，可作为一线药物用于AD的治疗，适合用于长期主动维持治疗。 在治疗初期，可先使用TCS快速控制症状，病情控制之后再转为TCI，面部等皮肤薄嫩部位可直接使用TCI，每日2次，直至皮损完全消退。进入维持期治疗后，可进行TCI的主动维持治疗，具体用法请参见本文“外用药物的应用原则”[16]。 TCI常见不良反应多为轻度局部症状，包括灼热感、瘙痒感、刺痛等，常在外用后5 min内出现，连续使用数天后可自行缓解，将药膏冷藏后使用可减少此类反应[17-19]。有研究表明，相比他克莫司，吡美莫司局部刺激反应发生率较低[20]。TCI长期使用不会引起皮肤萎缩[21]。 多项4年以上的临床研究显示，外用TCI与恶性肿瘤无相关性[22-23]。一项系统综述分析了110项研究的340万例患者显示，婴儿、儿童和成人使用TCI并不增加肿瘤风险[24]。2022年欧洲AD治疗指南[10]、2023年美国AD指南[25]均指出长期使用TCI与恶性肿瘤发生无相关性。 3. 磷酸二酯酶4（PDE-4）抑制剂：一类用于治疗炎症性疾病的非糖皮质激素药物，包括克立硼罗[26]、roflumilast[27]和difamilast[28]。PDE-4抑制剂可通过提高细胞内环磷酸腺苷水平，降低细胞因子的释放而发挥抗炎作用。目前，我国已批准克立硼罗软膏用于AD的治疗，而其他2种药物尚处于临床试验阶段。 克立硼罗软膏于2020年在中国上市，用于3月龄及以上轻中度AD患者。用法为每日2次，皮损消退后可停药，也可用于长期主动维持治疗。常见的不良反应为应用部位灼热或刺痛感，通常为轻中度[26，29]。一项系统综述显示，部分使用克立硼罗的患者有用药部位灼烧感[30]。 4. 芳香烃受体调节剂：芳香烃受体（aryl hydrocarbons receptor，AhR）是介导环境因素与免疫系统细胞成分相互作用的一种细胞信号传导体。皮肤细胞表达AhR受体， AhR通路参与维持皮肤稳态和皮肤炎症[31]。 在芳香烃受体调节剂中，本维莫德（benvitimod/tapinarof）在我国已获批用于治疗2岁及以上儿童和成人轻中度AD。本维莫德乳膏可通过抑制2型炎症细胞因子和修复皮肤屏障发挥治疗作用[32]。研究表明，本维莫德可抑制白细胞介素（IL）-4/IL-13诱导的紧密连接损伤，修复表皮屏障[33]。临床试验[34-36]显示，本维莫德可减轻和消除皮损，缓解瘙痒。本维莫德乳膏的不良反应大多数为轻中度，包括用药部位瘙痒、红斑和毛囊炎等。 5. Janus激酶（JAK）抑制剂：JAK家族是一类细胞质酪氨酸激酶，JAK和信号转导和转录激活因子（STAT）构成JAK-STAT通路，参与细胞因子的信号转导，包括IL-4、IL-13、IL-31等2型炎症细胞因子，在AD的发生和发展中发挥重要作用[37]。 目前已在美国、日本和欧盟上市的外用JAK抑制剂有芦可替尼（ruxolitinib）乳膏、迪高替尼（delgocitinib）软膏/乳膏[38-39]。尽管口服JAK抑制剂有黑框警告，但目前临床试验显示，外用JAK抑制剂安全性较好[40]。研究表明，外用芦可替尼乳膏治疗AD，第2周即可观察到皮损的改善和瘙痒减轻，并持续至第8周，患者的生活质量也得到明显改善，且用药部位不良反应较少见[41]。一项0.5%迪高替尼软膏的Ⅲ期临床研究[42]显示，治疗成人手部中重度AD时，迪高替尼组4周内手部湿疹严重程度指数（mEASI）评分改善显著优于对照组，疗效持续至28周，且不良事件多为轻度。目前，这两种药物在中国治疗AD的Ⅲ期临床试验尚在进行中。 6. 抗微生物制剂：当AD皮疹发生继发细菌感染，尤其是金黄色葡萄球菌感染，如出现脓疱、脓痂时，可联合外用抗生素或其他抗菌制剂以控制感染，选用2%莫匹罗星软膏、2%夫西地酸乳膏和复方多黏菌素B软膏等，疗程7 ~ 14 d，不建议长期使用。对于无明显皮肤感染者不建议预防性外用抗微生物制剂[25]。对于糖皮质激素治疗效果不佳的患者，可尝试外用抗菌药物联合TCS治疗[43]。渗出明显时，也可联合湿敷，如生理氯化钠溶液、2% ~ 4%硼酸溶液、0.1%乳酸依沙吖啶溶液等。 发生于头面、颈部、胸背部等脂溢区的AD皮损，有时可合并马拉色菌感染，可联合外用抗真菌制剂，如2%酮康唑洗剂。AD患者若发生单纯疱疹病毒感染，可口服和外用抗病毒药物1 ~ 2周，同时联合外用抗病毒药，如1%喷昔洛韦乳膏、3%阿昔洛韦乳膏。 7. 保湿润肤剂：保湿剂是AD的基础治疗，有利于修复皮肤屏障，缓解瘙痒，减少AD复发。建议有皮肤干燥的AD患者特别是低龄儿童和老年患者使用保湿剂，以维持正常的皮肤屏障功能。一般建议保湿剂与抗炎药分别使用，二者间隔1 h以上，不建议同时混用。 二、 外用药物的应用原则 AD治疗应根据疾病严重程度，遵循“阶梯治疗原则”。临床上轻度AD约占AD患者的2/3[44]，外用药物是AD的主要治疗手段。治疗中要合理应用外用药物，综合考虑疗效、安全性、患者年龄、皮损部位、皮损分期、皮损性质以及制剂类型等因素[10]。 应根据AD皮损特点选择适当的剂型，如皮肤干燥可使用保湿剂；急性非渗出性皮炎可使用乳膏或凝胶；急性皮损有渗出时，可选择湿敷；慢性角化性肥厚性皮损，可选择软膏联合封包或外贴硬膏。儿童与老年患者、薄嫩部位皮疹宜使用中弱效TCS或TCI。 AD外用治疗中常常会进行药物转换，一般治疗早期通常选择TCS，随着皮损改善，可逐步降低TCS的强度和频率，维持治疗可采用每周2 ~ 3次中弱效TCS或替换为非糖皮质激素类药物；皮肤薄嫩部位也可在治疗初始阶段使用TCI。研究证实，每周2 ~ 3次TCI可减少AD发作并能降低TCS使用频率[16]。以吡美莫司为例，皮损完全消退后，可在医生的指导下逐步降低给药频率，从每日2次减为每日1次、每2日1次，直至每周2 ~ 3次的最低维持剂量；或采用周末2日每日1次的方案，依从性更佳[16]。主动维持治疗方案的持续时间建议为12个月或更长，且每12个月需进行1次疗效和安全性评估，以决定是否继续治疗。TCI主动维持治疗的安全窗可延伸至5年以上，在实际应用中应结合患者个体情况、病情严重程度及既往治疗反应，制定个性化维持方案，并加强患者教育和随访管理[18]。 对于中重度AD，建议进行系统治疗的同时，结合外用药物[45-48]，如TCS、TCI等。病情改善或消退后可酌情减药。在系统药物减药过程中，AD可能复发。若复发较严重，往往需要加大系统药物剂量；若只是局部或轻度复发，建议先加强局部外用治疗。 三、 特殊部位用药 1. 薄嫩部位：面部是AD常见的皮肤薄嫩部位，面部AD皮疹的治疗需慎重[49]，不建议长期使用强效或超强效TCS，以避免形成激素依赖性皮炎。颈部、皮肤褶皱部位（如腹股沟、腋窝、腘窝、肘窝等）和会阴、肛周、乳房等薄嫩部位若使用强效激素也易发生不良反应[10，12，50]。建议选择药物强度适中、剂型温和的外用药物，尽量不用或慎用超强效和强效TCS，中效TCS也不宜大面积长期使用，弱效TCS可短时较大面积使用，不宜长期使用，以免引起皮肤萎缩、毛细血管扩张、膨胀纹等不良反应[14]。TCI不引起皮肤萎缩[21]，在皮肤薄嫩部位有治疗优势，可长期用药[51]。一项中国真实世界研究显示，1%吡美莫司乳膏对轻中度AD有效，尤其适用于皮肤薄嫩部位[52]。 2. 手足部位：皮肤较厚，药物吸收较差，同时手足部位因频繁活动，影响药物局部停留。手足部位皮疹首选TCS[10，13，53]，对于肥厚性皮损，外用药后可使用塑料薄膜进行封包，持续1 ~ 8 h不等，能促进药物吸收，增强疗效，促进皲裂愈合，减轻皮肤肥厚[12]。皮疹改善或消退后可用中弱效TCS、TCI或PDE-4抑制剂维持治疗。 3. 毛发部位：毛发覆盖部位可选择酊剂、洗剂或凝胶制剂。头皮部除经皮吸收外还有经毛囊吸收，因此含强效TCS不宜长期使用。若有糠秕马拉色菌感染，可联合局部抗真菌药物[54]，如吡硫锌、1%环吡酮、2%酮康唑。急性炎症红斑明显较多时，可选用中弱效TCS洗剂，也可选用含有糖皮质激素和抗真菌药物的复方制剂。 四、 特殊人群用药 1. 婴幼儿及儿童：婴幼儿和儿童的皮肤具有与成人不同的生理特点[55]，如皮肤薄嫩，含水量较高，pH值偏中性，屏障功能发育不完善，皮肤吸收面积大。因此，在为婴幼儿和儿童AD选择外用药物时，通常选用中弱效TCS或TCI，使用TCS时应避免大面积长期使用，一般不建议用强效及超强效TCS[56]。 儿童AD皮疹面积较大时可采用湿包（wet wrap therapy，WWT）疗法，尤其是急性渗出性皮疹。WWT可促进药物吸收、减轻瘙痒，并形成物理屏障防止搔抓，还可增加皮肤水合作用，减少经皮水分丢失[57-58]。WWT不良反应包括全身寒冷、毛囊炎、继发皮肤感染等，通常轻微和短暂[59-61]。 2. 老年人群：老年人皮肤有退行性变化，皮肤代谢变慢，皮脂腺汗腺功能下降，易发生皮肤干燥，屏障功能减退，对环境刺激和物理损伤的修复能力显著降低等，因此在治疗上应选择刺激性小、有修复皮肤屏障功能的药物[62]。皮疹无肥厚时可用中弱效TCS、TCI和PDE-4抑制剂，皮疹肥厚或干燥皲裂性皮疹可用强效或超强效TCS，必要时可用封包疗法；重度患者可在系统药物治疗基础上联合外用治疗。 3. 孕期、哺乳期人群：约20%的妊娠期患者可能在妊娠期加重[63]。妊娠期AD治疗包括润肤，外用中弱效TCS，面部、褶皱部位、腹部、大腿等部位可选用TCI。哺乳期患者易发生乳房AD，建议在哺乳后立即外用TCS或TCI以预防乳房或乳头AD，在下一次哺乳前清洁乳头，以避免婴儿接触外用药物。 五、 患者/家属教育 患者教育对于AD的长期管理十分重要。患者教育内容包括AD的病因、发病机制、临床特点，诱发和加重因素、日常注意事项、皮肤护理、正确用药、医患配合等多方面。应详尽指导患者正确使用外用药，如用药量、用药方法、疗程、可预期疗效和可能的不良反应及对策。叮嘱患者定期复诊，在随访过程中注意询问患者的反馈，观察病情变化和不良反应，及时调整治疗方案，通过科学管理，达到病情长期缓解和减少复发[50]。 六、 结语及展望 外用药物治疗是AD治疗的主要手段，合理规范应用外用药可显著提高疗效，减少不良反应，预防疾病复发。在使用外用药物过程中医生应给患者尽可能多的指导，以便患者能正确用药、提高疗效，预防不良反应。 本共识的制定方法存在一定局限性，未提供证据质量和推荐强度等级。未来新的外用药（如JAK抑制剂）将会陆续上市，皮肤科医师需要不断学习，不断实践，不断提高。随着中国临床研究数据的不断补充、更新，临床经验的不断积累，本共识未来将定期予以修订、更新。 七、 免责声明 本共识内容仅代表参与制订共识的专家意见，供临床医师参考。尽管参考了大量文献，且进行了广泛讨论，但可能存在不全面之处。本共识所提供的建议并非强制性意见，与本共识不一致的做法并不意味着错误或不当。AD治疗药物发展迅速，新型制剂与临床经验不断更新。因医学认知动态发展，本共识仅体现当前观点，后续将结合新证据定期修订，保障与临床及学科发展相符。 参与本共识制订的专家 （按姓氏拼音排序）： 陈爱军（重庆医科大学附属第一医院皮肤科）、陈柳青（武汉市第一医院皮肤科）、程雷[南京医科大学第一附属医院  江苏省人民医院变态反应（过敏）科/过敏诊疗中心]、邓丹琪（昆明医科大学第二附属医院皮肤科）、丁杨峰（上海市皮肤病医院皮肤科）、高兴华（中国医科大学附属第一医院皮肤科，国家卫生健康委和教育部免疫皮肤病学重点实验室）、耿松梅（西安交通大学第二附属医院皮肤科）、顾恒（中国医学科学院皮肤病医院）、郭一峰（上海交通大学医学院附属新华医院皮肤科）、纪超（福建医科大学附属第一医院皮肤科）、蒋献（四川大学华西医院皮肤科）、康晓静（新疆维吾尔自治区人民医院皮肤科）、赖维（中山大学附属第三医院皮肤科）、李捷（中南大学湘雅医院皮肤科）、李巍（复旦大学附属华山医院皮肤科）、刘光辉[香港中文大学（深圳）医院过敏反应科]、刘红（山东第一医科大学附属皮肤病医院）、刘强（河北医科大学第二医院皮肤科）、马琳（首都医科大学附属北京儿童医院皮肤科）、潘萌（上海交通大学医学院附属瑞金医院皮肤科）、宋志强（陆军军医大学西南医院皮肤科）、王华（重庆医科大学附属儿童医院皮肤科）、王晓玲（首都医科大学附属北京儿童医院药学部）、王晓艳（首都医科大学附属北京世纪坛医院皮肤科）、魏爱华（首都医科大学附属北京同仁医院皮肤科）、杨斌（南方医科大学皮肤病医院皮肤科）、姚煦（中国医学科学院皮肤病医院过敏与风湿免疫科）、于聪（北京大学人民医院皮肤科）、张建中（北京大学人民医院皮肤科）、周薇（北京大学第三医院儿科）、祝戎飞（华中科技大学同济医学院附属同济医院过敏反应科）、禚风麟（首都医科大学附属北京友谊医院皮肤科） 执笔者： 于聪 利益冲突： 所有作者均声明不存在利益冲突 参    考    文    献 [1] 中华医学会, 中华医学会杂志社, 中华医学会皮肤性病学分会, 等. 特应性皮炎基层诊疗指南(2022年)[J]. 中华全科医师杂志, 2022,21(7):609-619. doi: 10.3760/cma.j.cn114798-20220215-00102.  [2] Sroka-Tomaszewska J, Trzeciak M. 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