Data Highlight Positive Outcomes in Uncontrolled Gout With KRYSTEXXA
®
and Progress in Addressing
Sjögren's
Disease
THOUSAND OAKS, Calif., June 12, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of data across its diverse portfolio and pipeline at the European Alliance of Associations for Rheumatology's (EULAR) 2024 Congress, June 12-15 in Vienna. The 27 abstracts from Amgen-sponsored and partner-led studies demonstrate Amgen's commitment to improving the lives of patients living with inflammatory and rheumatic disease through the development of novel medicines.
Key presentations include the first findings showing dazodalibep improved major biomarkers in Sjögren's disease, as well as data on treatment outcomes for uncontrolled gout based on a post-hoc analysis of the MIRROR trial for KRYSTEXXA® (pegloticase) with methotrexate.
"We are deeply committed to advancing patient care through continuous innovation and rigorous science. The data presented at EULAR 2024 further demonstrate our efforts to address complex diseases," said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen. "By advancing scientific research, we are not only enhancing our understanding of these conditions, but also paving the way for more effective treatments that have the potential to significantly improve patient outcomes."
Additional presentations include new long-term data from the FOREMOST study of Otezla® (apremilast) in early oligoarticular psoriatic arthritis, as well as a post-hoc analysis of TAVNEOS® (avacopan) versus prednisone taper in patients with severe active MPA/GPA and active ear, nose or throat manifestations.
For more information on the Amgen abstracts, see below.
Abstracts and Presentation Times:
Amgen-Sponsored Abstracts
Dazodalibep
CD40L blockade with dazodalibep significantly improves disease activity, swollen and tender joint counts, while reducing multiple T- and B-cell biomarkers in the MIDORA phase 2 study of patients with moderate-to-severe active rheumatoid arthritis
Abstract #AB0746, Rheumatoid Arthritis (Publication only)
Dazodalibep (anti-CD40L) effectively reduces multiple proteins associated with B-, T, and dendritic cell biomarkers in Sjögren's disease: Corroboration of immunophenotyping findings from the ALISS phase 2 study
Abstract #OP0058, Clinical Abstract Sessions: New Targets and New Treatments in Sjön's Disease (Oral Abstract Presentations), Wednesday, June 12 from 5:00 to 5:10 p.m. CDT
Sjögren's Disease
Global burden of Sj
ö
gren's
disease (SjD): Findings from a systematic literature review (SLR) of humanistic and clinical outcomes
Abstract #AB0815, Sjögren`s syndrome (Publication Only)
KRYSTEXXA®
(pegloticase)
Achievement of "gout remission" during intensive urate-lowering over 52 weeks of pegloticase therapy
Abstract #POS0239, Clinical Poster Tours: Gout treatment in 2024 (Poster Tours), Friday, June 14 at 9:30 a.m. CDT
Influence of acute gout flare and serum urate lowering on biomarkers of systemic inflammation
Abstract #AB0114, Crystal related disorders (Publication Only)
Patient-reported quality of life in uncontrolled gout and changes with intensive urate-lowering: Comparison of tophaceous and non-tophaceous patients
Abstract #AB0112, Crystal related disorders (Publication Only)
Pre-infusion glucocorticoid reduction/elimination in patients with uncontrolled gout treated with pegloticase and methotrexate: Experience of one community rheumatology practice
Abstract #POS0936, Crystal related disorders (Poster View), Friday, June 14 at 9:30 a.m. CDT
Uncontrolled Gout
Cardiovascular disease, chronic kidney disease, pain, and psychological issues in patients with controlled vs. uncontrolled gout: A retrospective claims-based cohort analysis
Abstract #POS0569, Crystal related disorders (Poster View), Wednesday, June 12 at 3:30 p.m. CDT
The concept of gout remission as viewed by rheumatologists, nephrologists, and primary care physicians
Abstract #POS0269, Clinical Poster Tours: Gout treatment in 2024 (Poster Tours), Friday, June 14 at 9:30 a.m. CDT
Treatment patterns and quality of life in patients with controlled and uncontrolled gout
Abstract #POS0940, Crystal related disorders (Poster View), Friday, June 14 at 9:30 a.m. CDT
Otezla®
(apremilast)
Apremilast reduces axial inflammation in patients with psoriatic arthritis as assessed by CANDEN MRI scoring: Results from the phase 4 MOSAIC study
Abstract #POS0982, Psoriatic arthritis (Poster View), Friday, June 14 at 9:30 a.m. CDT
Apremilast reduces inflammation as measured by MRI, clinical outcomes, and patient-reported outcomes in patients with psoriatic arthritis: Results from the phase 4 MOSAIC study
Abstract #POS0968, Psoriatic arthritis (Poster View), Friday, June 14 at 9:30 a.m. CDT
Apremilast treatment in early oligoarticular psoriatic arthritis (PsA) improves clinical and patient-reported outcomes for up to 48 weeks – Data from the FOREMOST study
Abstract #POS0976, Psoriatic arthritis (Poster View), Friday, June 14 at 9:30 a.m. CDT
Apremilast for psoriatic arthritis in the Netherlands: Real-world data from the REWARD study
Abstract #AB0453, Psoriatic arthritis (Publication Only)
The use of disease activity thresholds for the Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire to assess patient perceptions of disease burden in patients with early oligoarticular psoriatic arthritis treated with apremilast in the FOREMOST study
Abstract #AB0473, Psoriatic arthritis (Publication Only)
Prolia® (denosumab)
Comparative effectiveness of denosumab versus bisphosphonates among treatment-experienced postmenopausal women with osteoporosis in the U.S. Medicare program
Abstract #POS0089, Clinical Poster Tours: Treatment Options in Metabolic bone diseases and Osteoporosis (Poster Tours), Thursday, June 13 at 9:54 a.m. CDT
Comparative effectiveness of denosumab versus zoledronic acid among postmenopausal women with osteoporosis in the U.S. Medicare program
Abstract #POS0583, Other diseases (Poster View), Thursday, June 13 at 9:30 a.m. CDT
Risk of fragility fracture after long-term discontinuation of osteoporosis treatment in po
st-menopausal osteoporosis women in France: A population-based study conducted on the nationwide claim database (SNDS)
Abstract #OP0035, Clinical Abstract Sessions: Risk factors and treatment in osteoporosis (Oral Abstract Presentations), Wednesday, June 12 at 4:50 p.m. CDT
TAVNEOS®
(avacopan)
Avacopan versus prednisone taper in patients with ANCA-associated vasculitis and ear,
nose, or throat involvement
Abstract #OP0174, Clinical Abstract Sessions: Vasculitis across different vessel sizes (Oral Abstract Presentations), Thursday, June 13 at 11:20 a.m. CDT
Data from the ADVOCATE trial on 28 patients with ANCA-associated vasculitis who received avacopan without concomitant glucocorticoid use in the first 29 days
Abstract #POS0246, Clinical Poster Tours: Miscellaneous in Vasculitis (Poster Tours), Friday, June 14 at 9:36 a.m. CDT
UPLIZNA
®
(
inebilizumab-cdon
)
Burden of glucocorticoid use and associated toxicities in commercially insured adults with IgG4-related disease
Abstract #POS0357, Clinical Poster Tours: IgG4 Related Disease (Poster Tours), Friday, June 14 at 2:45 p.m. CDT
Insights into the design and study population of MITIGATE: The first multinational randomized controlled clinical trial in IgG4-related disease (IgG4-RD), evaluating the efficacy and safety of inebilizumab
Abstract #POS0347, Clinical Poster Tours: IgG4 Related Disease (Poster Tours), Friday, June 14 at 2:45 p.m. CDT
Partner-Led Abstracts
Sjögren's Disease
The use of natural language processing to characterize disease burden: Sexual distress in
Sjögren's disease
Abstract #AB0793, Sjön`s syndrome (Publication Only)
Using social media listening to characterize the flare lexicon in patients with
Sjögren's disease
Abstract #AB0794, Sjön`s syndrome (Publication Only)
TAVNEOS®
(avacopan)
Safety and effectiveness of avacopan beyond 52 weeks: Experience to date in the Early Access Program (EAP)
Abstract #POS0865, Vasculitis, small and medium size vessels (Poster View), Thursday, June 13 at 2:45 p.m. CDT
Design of AVACOSTAR: A real-world study of avacopan in ANCA-associated vasculitis (AAV)
Abstract #AB1241, Vasculitis, small and medium size vessels (Publication Only)
Uncontrolled Gout
Osteoporosis in patients with gout in the United States
Abstract #POS0563, Crystal related disorders (Poster View), Wednesday, June 12 at 3:30 p.m. CDT
About KRYSTEXXA® (pegloticase)
KRYSTEXXA
® (pegloticase) is the first and only biologic approved by the FDA to treat adults living with uncontrolled gout, a painful and debilitating inflammatory condition with which people continue to have abnormally high levels of uric acid and symptoms despite the use of conventional therapies.
In 2022, the FDA approved expanding labeling to include co-administration with the immunomodulator methotrexate, based on results from the MIRROR randomized controlled trial, which showed significant improvements in efficacy and safety, including a reduction in infusion reactions.
About Uncontrolled Gout
Gout is a chronic, progressive inflammatory form of arthritis that is caused by high urate levels in the body. Tiny needle-like crystals can form and build up almost anywhere in the body. Patients with uncontrolled gout continue to have high levels of uric acid and ongoing symptoms of gout despite the use of oral urate-lowering therapies. Uncontrolled gout is a chronic, systemic disease, and if not addressed can have significant clinical consequences.
KRYSTEXXA U.S. Indication
KRYSTEXXA (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
KRYSTEXXA U.S. Important Safety Information
WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA
Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
Anaphylaxis may occur with any infusion, including a first infusion and generally manifests within 2 hours of the infusion. Delayed hypersensitivity reactions have also been reported.
KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
Patients should be premedicated with antihistamines and corticosteroids and closely monitored for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
Serum uric acid levels should be monitored prior to each infusion and treatment discontinued if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
Patients at risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency should be screened prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency.
CONTRAINDICATIONS
In patients with G6PD deficiency.
In patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.
WARNINGS AND PRECAUTIONS
Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.
Congestive Heart Failure: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in the pre-marketing placebo-controlled clinical trials experienced exacerbation. Caution should be exercised in patients who have congestive heart failure and patients should be closely monitored following infusion.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5%) are:
KRYSTEXXA co-administration with methotrexate trial: gout flares, arthralgia, COVID-19, nausea and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reactions, pain in extremity, hypertension and vomiting.
KRYSTEXXA pre-marketing placebo-controlled trials: gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.
Please see Full Prescribing Information, including Boxed Warning.
About Otezla®
(apremilast)
Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.
Since its initial FDA approval in 2014, Otezla has been prescribed to more than 840,000 patients worldwide.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic, inflammatory form of arthritis, which can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. It is estimated that nearly 38 million people worldwide have psoriatic arthritis. Around a third of people living with psoriasis may go on to develop psoriatic arthritis. If left untreated, psoriatic arthritis can cause disability.
Otezla U.S. Indications
Otezla (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.
Otezla U.S. Important Safety Information
Contraindications
Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation
Warnings and Precautions
Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy
Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
Behçet's Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
Behçet's Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended
Adverse Reactions
Plaque Psoriasis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in patients with mild to moderate plaque psoriasis was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis
Psoriatic Arthritis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache
Behçet's Disease: The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection.
Use in Specific Populations
Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss.
Please click here for Otezla® Full Prescribing Information.
About TAVNEOS® (avacopan)
TAVNEOS® (avacopan), approved by the FDA as an adjunctive treatment of severe active ANCA-associated vasculitis (GPA/MPA), is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action. TAVNEOS blocks the complement 5a receptor (C5aR) from binding C5a, the pro-inflammatory complement system fragment. This is presumed to block C5a-mediated neutrophil activation and migration. The precise mechanism of TAVNEOS in ANCA-associated vasculitis (GPA/MPA) has not been definitively established.
About ANCA-Associated Vasculitis
ANCA-associated vasculitis is an umbrella term for a group of multi-system autoimmune diseases with small vessel inflammation. Inflamed vessels may rupture or become occluded giving rise to a broad array of clinical symptoms and signs related to a systemic inflammatory response which may result in profound impairment in the kidneys, lungs and other organs. Prior to the approval of TAVNEOS in severe active ANCA-associated vasculitis (GPA/MPA), the combination of immunosuppressants most often used for the treatment of ANCA-associated vasculitis (GPA/MPA) include cyclophosphamide or rituximab, combined with daily glucocorticoids (steroids) for prolonged periods, which can be associated with significant clinical consequences.
TAVNEOS U.S. Indication
TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
TAVNEOS U.S. Important Safety Information
Contraindications
Serious hypersensitivity to avacopan or to any of the excipients.
Warning and Precautions
Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease.
Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established.
Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.
Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common.
Adverse Reactions
The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.
Drug Interactions
Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.
Please see Full Prescribing Information and
Medication Guide.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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