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

• DOI: 10.1136/rmdopen-2022-002735
• Publication Date: 2023-02-08T15:25:48Z
• Authors: Gerd R Burmester; Stanley B Cohen; Kevin L Winthrop; Peter Nash; Alan D Irvine; Atul Deodhar; Eduardo Mysler; Yoshiya Tanaka; John Liu; Ana P Lacerda; Hannah Palac; Tim Shaw; Philip J Mease; Emma Guttman‑Yassky
• Keywords: Arthritis, Psoriatic; R; 3. Good health; Dermatitis, Atopic; Arthritis, Rheumatoid; 03 medical and health sciences; 0302 clinical medicine; Antirheumatic Agents; Medicine; Humans; Inflammatory Arthritis; Spondylitis, Ankylosing

To evaluate the long-term safety profile for upadacitinib across rheumatoid arthritis (RA), psoriatic (PsA), ankylosing spondylitis (AS) and atopic dermatitis (AD).Safety data from clinical trials of 15 mg 30 (AD only) treating RA, PsA, AS AD as June 2021 were analysed; some RA PsA studies included adalimumab methotrexate active comparators. Treatment-emergent adverse events (TEAEs) presented by disease exposure-adjusted event rates per 100 patient years (E/100 PY).The analysis 6991 patients (RA, n=3209; n=907; AS, n=182; AD, n=2693) who received at least one dose upadacitinib, representing 425 PY exposure (maximum duration 2.75-5.45 years) diseases. Rates PY) any TEAE (205.5-278.1) leading to discontinuation (4.5-5.4) similar diseases; serious TEAEs numerically higher in with PsA. herpes zoster (1.6-3.6), non-melanoma skin cancer (0-0.8) elevations creatine phosphokinase levels (4.4-7.9) than comparators populations. Deaths (0-0.8), infections (0-3.9), major cardiovascular (0-0.4), venous thromboembolism (<0.1-0.4) malignancies (0.3-1.4) observed, generally lowest AD. Increased acne observed only.Findings this demonstrate that is well tolerated differences profiles likely reflective varying characteristics populations.NCT02675426, NCT02706951, NCT02706847, NCT02629159, NCT02706873, NCT03086343, NCT03104374, NCT03104400, NCT03178487, NCT03569293, NCT03568318 NCT03607422.