Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany
Department of Rheumatology, Metroplex Clinical Research Center, Dallas, Texas, USA.
RMD Open. 2023 Feb;9(1). doi: 10.1136/rmdopen-2022-002735.
To evaluate the long-term safety profile for upadacitinib across rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and atopic dermatitis (AD).
Safety 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).
The 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.
Findings 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.
NCT02675426, NCT02706951, NCT02706847, NCT02629159, NCT02706873, NCT03086343, NCT03104374, NCT03104400, NCT03178487, NCT03569293, NCT03568318 and NCT03607422.
评估乌帕替尼在类风湿关节炎（RA）、银屑病关节炎（PsA）、强直性脊柱炎（AS）和特应性皮炎（AD）中的长期安全性概况。
截至 2021 年 6 月 30 日，分析了乌帕替尼 15mg 和乌帕替尼 30mg（仅 AD）治疗 RA、PsA、AS 和 AD 的临床试验中的安全性数据；一些 RA 和 PsA 研究包括阿达木单抗和甲氨蝶呤作为活性对照。通过疾病报告治疗期间出现的不良事件（TEAE），以每 100 患者年（E/100 PY）暴露调整的事件发生率（E/100 PY）呈现。
该分析纳入了 6991 名患者（RA，n=3209；PsA，n=907；AS，n=182；AD，n=2693），他们至少接受了一次乌帕替尼治疗，代表了 15425 个患者年的暴露（最长持续时间 2.75-5.45 年）。在所有疾病中，任何 TEAE（205.5-278.1）和导致停药的 TEAE（4.5-5.4）的发生率（E/100 PY）相似；RA 和 PsA 患者的严重 TEAE 发生率略高。带状疱疹（1.6-3.6）、非黑色素瘤皮肤癌（0-0.8）和肌酸磷酸激酶水平升高（4.4-7.9）的发生率高于 RA 和 PsA 人群中的活性对照药物。在 RA 和 PsA 人群中，死亡率（0-0.8）、严重感染（0-3.9）、主要不良心血管事件（0-0.4）、静脉血栓栓塞症（<0.1-0.4）和恶性肿瘤（0.3-1.4）的发生率也观察到，在 AS 和 AD 中通常最低。仅在 AD 患者中观察到痤疮发生率增加。
这项分析的结果表明，乌帕替尼通常具有良好的耐受性，安全性特征的差异可能反映了 RA、PsA、AS 和 AD 人群中不同的患者特征。
NCT02675426、NCT02706951、NCT02706847、NCT02629159、NCT02706873、NCT03086343、NCT03104374、NCT03104400、NCT03178487、NCT03569293、NCT03568318 和 NCT03607422。
