Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis

被引：146

作者：

Burmester, Gerd R. ^{[1
]}

Cohen, Stanley B. ^{[2
]}

Winthrop, Kevin L. ^{[3
]}

Nash, Peter ^{[4
]}

Irvine, Alan D. ^{[5
,6
]}

Deodhar, Atul ^{[3
]}

Mysler, Eduardo ^{[7
]}

Tanaka, Yoshiya ^{[8
]}

Liu, John ^{[9
]}

Lacerda, Ana P. ^{[9
]}

Palac, Hannah ^{[9
]}

Shaw, Tim ^{[10
]}

Mease, Philip J. ^{[11
]}

Guttman-Yassky, Emma ^{[12
]}

机构：

[1] Charite Univ Med Berlin, Dept Rheumatol & Clin Immunol, Berlin, Germany

[2] Metroplex Clin Res Ctr, Dept Rheumatol, Dallas, TX USA

[3] Oregon Hlth & Sci Univ, Div Infect Dis, Portland, OR USA

[4] Griffith Univ, Sch Med, Brisbane, Qld, Australia

[5] Trinity Coll Dublin, Dept Clin Med, Dublin, Ireland

[6] St James Hosp, Wellcome HRB Clin Res Facil, Dublin, Ireland

[7] Org Med Invest, Rheumatol, Buenos Aires, Argentina

[8] Univ Occupat & Environm Hlth Japan, Dept Internal Med 1, Kitakyushu, Japan

[9] AbbVie Inc, N Chicago, IL USA

[10] AbbVie Ltd, Lab Inflammatory Skin Dis, Maidenhead, NY, England

[11] Providence St Joseph Hlth, Swedish Med Ctr, Rheumatol Res Div, Seattle, WA USA

[12] Icahn Sch Med Mt Sinai, Dept Dermatol, New York, NY USA

来源：

RMD OPEN | 2023年 / 9卷 / 01期

关键词：

Arthritis; Psoriatic; Rheumatoid; Spondylitis; Ankylosing; Antirheumatic Agents; Inflammation; DOUBLE-BLIND; RISK; ADOLESCENTS; DISEASES; PLACEBO; ADULTS; TRIAL;

D O I：

10.1136/rmdopen-2022-002735

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

ObjectiveTo evaluate the long-term safety profile for upadacitinib across rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and atopic dermatitis (AD).MethodsSafety data from clinical trials of upadacitinib 15 mg and upadacitinib 30 mg (AD only) for treating RA, PsA, AS and AD as of 30 June 2021 were analysed; some RA and PsA studies included adalimumab and methotrexate as active comparators. Treatment-emergent adverse events (TEAEs) were presented by disease as exposure-adjusted event rates per 100 patient years (E/100 PY).ResultsThe analysis included 6991 patients (RA, n=3209; PsA, n=907; AS, n=182; AD, n=2693) who received at least one dose of upadacitinib, representing 15 425 PY of exposure (maximum duration 2.75-5.45 years) across diseases. Rates (E/100 PY) of any TEAE (205.5-278.1) and TEAE leading to discontinuation (4.5-5.4) were similar across diseases; serious TEAEs were numerically higher in patients with RA and PsA. Rates of herpes zoster (1.6-3.6), non-melanoma skin cancer (0-0.8) and elevations in creatine phosphokinase levels (4.4-7.9) were higher with upadacitinib than with active comparators in the RA and PsA populations. Deaths (0-0.8), serious infections (0-3.9), major adverse cardiovascular events (0-0.4), venous thromboembolism (< 0.1-0.4) and malignancies (0.3-1.4) were observed, with rates generally lowest in AS and AD. Increased rates of acne were observed in patients with AD only.ConclusionsFindings from this analysis demonstrate that upadacitinib is generally well tolerated with observed differences in safety profiles likely reflective of varying patient characteristics across RA, PsA, AS and AD populations.

引用

页数：11