JAK in the [Black] Box: A Dermatology Perspective on Systemic JAK Inhibitor Safety

Article Allergy

Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results

Jonathan Silverberg et al.

Summary: The study demonstrated that upadacitinib + TCS had long-term maintenance of efficacy and a favorable safety profile in patients with moderate-to-severe atopic dermatitis.

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY (2022)

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Article Dermatology

Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: Results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial

Andrew Blauvelt et al.

Summary: The study demonstrated that most patients who continued abrocitinib treatment did not experience a flare during maintenance, and rescue treatment with abrocitinib plus topical therapy effectively restored response.

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY (2022)

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Meeting Abstract Rheumatology

RISK OF VENOUS THROMBOEMBOLIC EVENTS IN PATIENTS WITH RHEUMATOID ARTHRITIS AGED ≥50 YEARS WITH ≥1 CARDIOVASCULAR RISK FACTOR: RESULTS FROM A PHASE 3B/4 RANDOMISED STUDY OF TOFACITINIB VS TUMOUR NECROSIS FACTOR INHIBITORS

C. Charles-Schoeman et al.

ANNALS OF THE RHEUMATIC DISEASES (2022)

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Article Gastroenterology & Hepatology

Safety of Tofacitinib in a Real-World Cohort of Patients With Ulcerative Colitis

Parakkal Deepak et al.

Summary: In a real-world study of UC patients given tofacitinib, adverse events occurred in 15.7% of patients, most of which were infections. Serious adverse events occurred at a rate of 10.0%, with HZ infection and VTE primarily occurring in patients receiving 10 mg tofacitinib twice per day.

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY (2021)

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Article Dermatology

Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials

T. Bieber et al.

Summary: This study reports pooled safety data for baricitinib in patients with moderate-to-severe AD, confirming the established safety profile of baricitinib in this population.

JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY (2021)

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Article Dermatology

Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials

Brett King et al.

Summary: This study evaluated the safety of baricitinib 2 mg in treating moderate-to-severe AD, and found that treatment-emergent adverse events were higher with the drug compared to placebo, but serious adverse events were low and similar between the two groups. The integrated analysis confirmed the established safety profile of baricitinib 2 mg in patients with AD, but longer exposure to treatment is needed to assess the risks of malignancies and major adverse cardiovascular events.

AMERICAN JOURNAL OF CLINICAL DERMATOLOGY (2021)

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Article Medicine, General & Internal

Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis

Thomas Bieber et al.

Summary: The study demonstrated that both 200 mg and 100 mg doses of abrocitinib showed significant efficacy in treating moderate-to-severe atopic dermatitis compared to placebo, with the 200 mg dose being superior to dupilumab in improving itch response. Neither dose of abrocitinib showed significant differences from dupilumab in most other key secondary endpoints at week 16.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Article Rheumatology

Venous Thromboembolism Risk With JAK Inhibitors: A Meta-Analysis

Mark Yates et al.

Summary: A meta-analysis of RCT data on JAK inhibitors in IMID patients found a low risk of VTE, not supporting current warnings. These findings will help in the continued development of clinical guidelines for the use of JAK inhibitors in IMIDs.

ARTHRITIS & RHEUMATOLOGY (2021)

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Article Dermatology

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program

Eric L. Simpson et al.

Summary: Abrocitinib has been shown to be an effective treatment for atopic dermatitis with a manageable tolerability and safety profile for long-term use, especially when proper patient and dose selection are utilized. The study results suggest that abrocitinib can be used as a long-term therapy for moderate-to-severe atopic dermatitis.

AMERICAN JOURNAL OF CLINICAL DERMATOLOGY (2021)

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Article Medicine, General & Internal

Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial

Kristian Reich et al.

Summary: This study evaluated the efficacy and safety of upadacitinib in combination with topical corticosteroids for moderate-to-severe atopic dermatitis, showing that upadacitinib was more effective and well tolerated compared to placebo.

LANCET (2021)

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Article Medicine, General & Internal

Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double- blind, randomised controlled phase 3 trials

Emma Guttman-Yassky et al.

Summary: The clinical trials demonstrated that Upadacitinib may be an effective treatment option for moderate-to-severe atopic dermatitis, with a significant improvement in symptoms for most patients within 16 weeks, and both dosages were well tolerated.

LANCET (2021)

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Article Dermatology

Incidence of Venous Thromboembolism in Patients With Dermatologist-Diagnosed Chronic Inflammatory Skin Diseases

Maria C. Schneeweiss et al.

Summary: In this large-scale cohort study, chronic inflammatory skin diseases (CISDs) were not found to be associated with an increased incidence of venous thromboembolism (VTE) after controlling for relevant VTE risk factors in a representative dermatology patient population.

JAMA DERMATOLOGY (2021)

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Article Dermatology

Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis A Randomized Clinical Trial

Andrew Blauvelt et al.

Summary: This study compared the safety and efficacy of upadacitinib vs dupilumab in patients with moderate-to-severe atopic dermatitis, with the results showing superior efficacy of upadacitinib at week 16 compared to dupilumab, with no new safety signals identified.

JAMA DERMATOLOGY (2021)

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Article Gastroenterology & Hepatology