Data on treatment switching directly from tumor necrosis factor inhibitors to tofacitinib in psoriatic arthritis (PsA) are limited. This post hoc analysis assessed efficacy and safety outcomes in patients with PsA who directly switched to tofacitinib in a long-term extension (LTE) study after receiving adalimumab (ADA) in a Phase 3 study, compared with those who continued to receive tofacitinib. Patients with active PsA received tofacitinib 5 mg twice daily (BID) or ADA 40 mg once every 2 weeks in a 12-month, randomized, double-blind study (OPAL Broaden) and then continued or switched to tofacitinib 5 mg BID and maintained this dose in an open-label LTE study (OPAL Balance). Efficacy was assessed 3 months before the last visit and at the last visit in the Phase 3 study, and at month 3 (or month 6 for select outcomes) in the LTE study and included rates of ≥ 20/50/70% improvement in American College of Rheumatology response criteria, Psoriasis Area and Severity Index ≥ 75% improvement, Health Assessment Questionnaire-Disability Index (HAQ-DI) response (decrease from baseline ≥ 0.35 for patients with baseline HAQ-DI ≥ 0.35), Psoriatic Arthritis Disease Activity Score ≤ 3.2, and minimal disease activity; and change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue score. Safety was assessed at months 3 and 12 in both studies via incidence rates (patients with first events/100 patient-years). Overall, 180 patients were included (ADA→tofacitinib 5 mg BID: n = 91; continuing tofacitinib 5 mg BID: n = 89). At Phase 3 baseline, patients in the ADA→tofacitinib 5 mg BID group tended to be younger and have less active disease compared with those continuing tofacitinib. Efficacy was similar between groups in the Phase 3 study, and was maintained to month 3 or 6 in the LTE study. Treatment-emergent adverse events (AEs), serious AEs, and serious infections were generally similar in the Phase 3 and LTE studies, and between groups within each study. Tofacitinib efficacy and safety were similar in patients with PsA who directly switched from ADA to tofacitinib and those who continued tofacitinib, suggesting that patients can be directly switched from ADA to tofacitinib without any washout period. NCT01877668; NCT01976364

中文翻译：

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托法替布在 3 期随机对照研究中接受阿达木单抗或托法替布治疗的银屑病关节炎患者开放标签、长期扩展研究中的疗效和安全性：事后分析


关于银屑病关节炎 （PsA） 中直接从肿瘤坏死因子抑制剂转换为托法替布的治疗数据有限。这项事后分析评估了在一项 3 期研究中接受阿达木单抗 （ADA） 后在长期延长 （LTE） 研究中直接改用托法替布的 PsA 患者的疗效和安全性结果，与继续接受托法替布的患者相比。在一项为期 12 个月的随机双盲研究 （OPAL Broaden） 中，活动性 PsA 患者接受托法替布 5 mg 每日两次 （BID） 或 ADA 40 mg，每 2 周一次 （OPAL Broaden），然后在一项开放标签 LTE 研究中继续或改用托法替布 5 mg BID 并维持该剂量 （OPAL Balance）。在 3 期研究的最后一次就诊前和最后一次就诊前 3 个月以及 LTE 研究的第 3 个月（或选定结果的第 6 个月）评估疗效，包括美国风湿病学会反应标准≥ 20/50/70% 的改善率，银屑病面积和严重程度指数≥ 75% 改善，健康评估问卷-残疾指数 （HAQ-DI） 反应（基线 HAQ-DI 患者从基线 ≥ 0.35 下降 0.35 ≥ 0.35）， 银屑病关节炎疾病活动评分 ≤ 3.2，疾病活动度最低;以及慢性病治疗功能评估-疲劳评分相对于基线的变化。在两项研究中，在第 3 个月和第 12 个月通过发病率 （首次事件患者/100 患者年） 评估安全性。总体纳入 180 例患者 （ADA→托法替布 5 mg BID： n = 91;继续使用托法替布 5 mg BID： n = 89）。在 3 期基线时，与继续使用托法替布的患者相比，ADA→托法替布 5 mg BID 组的患者往往更年轻，疾病活动性更低。 在 3 期研究中，两组疗效相似，在 LTE 研究中维持到第 3 个月或第 6 个月。治疗中出现的不良事件 （AEs） 、严重 AEs 和严重感染在 3 期和 LTE 研究中以及每项研究的组间通常相似。托法替布在直接从 ADA 转为托法替布的 PsA 患者中的有效性和安全性与继续使用托法替布的患者相似，表明患者可以直接从 ADA 转为托法替布，无需任何清除期。NCT01877668;NCT01976364