Rheumatology, University Hospital La Paz, IdiPAZ, Madrid, Spain.
Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA.
Arthritis Res Ther. 2024 May 24;26(1):105. doi: 10.1186/s13075-024-03313-w.
Tofacitinib is an oral Janus kinase inhibitor for treatment of ankylosing spondylitis (AS). Time to improvement in core domains of AS was estimated in tofacitinib-treated patients with AS.
This post hoc analysis used phase 3 trial data from patients with AS receiving tofacitinib 5 mg twice daily or placebo to week (W)16; all patients received open-label tofacitinib W16-48.
nocturnal pain; total back pain; fatigue, spinal pain, peripheral joint pain/swelling, enthesitis, and morning stiffness (Bath AS Disease Activity Index [BASDAI] questions 1-6); BASDAI total score; AS Disease Activity Score (ASDAS). Median time to improvement events was estimated using non-parametric Kaplan-Meier models. Improvement events were defined as initial (first post-baseline observation) and continued (sustained for 2 consecutive visits) ≥ 30% and ≥ 50% improvement in back/nocturnal pain or BASDAI questions/total scores, or ASDAS improvement ≥ 1.1 and ≥ 2.0 points.
269 patients (tofacitinib: n = 133; placebo-to-tofacitinib: n = 136) were assessed. Median time to improvement was shorter, and more patients experienced improvements with tofacitinib vs. placebo-to-tofacitinib; differences observed from W2 (first post-baseline assessment). Median time to initial (continued) ≥ 30% pain improvement was 4 (4-8) weeks for tofacitinib vs. 24 (24) weeks for placebo-to-tofacitinib (8 [8] weeks post-switch). Median time to initial (continued) ≥ 50% improvement of pain, peripheral joint pain/swelling and enthesitis, morning stiffness, BASDAI total score, and fatigue was 8-24 (12-40) weeks with tofacitinib vs. 24-32 weeks (32 weeks-not estimable [NE]) with placebo-to-tofacitinib. Median time to initial (continued) ASDAS improvement ≥ 1.1 points was 4 (8) weeks for tofacitinib vs. 24 (24) weeks for placebo-to-tofacitinib, and NE for improvement ≥ 2.0 points with either treatment.
Improvements in AS core domains occurred more rapidly with tofacitinib vs. placebo-to-tofacitinib. Half of tofacitinib-treated patients with AS will likely experience improvements ≥ 30% in pain and ≥ 1.1 points in ASDAS during month (M)1, ≥ 50% improvement in nocturnal pain and enthesitis by M2, and in morning stiffness by M3. Results show that initiating tofacitinib as soon as possible is associated with quicker improvements in AS core domains vs. delaying treatment.
ClinicalTrials.gov, NCT03502616, 11 April 2018.
托法替布是一种用于治疗强直性脊柱炎（AS）的口服 Janus 激酶抑制剂。本研究旨在评估接受托法替布治疗的 AS 患者在 AS 的核心领域的改善时间。
这是一项事后分析，使用了接受托法替布 5mg，每日两次或安慰剂治疗的 AS 患者的 3 期试验数据，直至第 16 周（所有患者均接受托法替布开放标签治疗，第 16-48 周）。
269 例患者（托法替布：n=133；安慰剂至托法替布：n=136）进行了评估。与安慰剂至托法替布相比，托法替布治疗的患者达到改善的时间更短，更多患者经历了改善；差异在基线后首次评估时（第 2 周）即可观察到。托法替布组达到初始（持续）≥30%疼痛改善的中位时间为 4（4-8）周，而安慰剂至托法替布组为 24（24）周（转换后 8[8]周）。托法替布组达到初始（持续）≥50%疼痛、外周关节疼痛/肿胀和附着点炎、晨僵、BASDAI 总分和疲劳改善的中位时间为 8-24（12-40）周，而安慰剂至托法替布组为 24-32 周（32 周不可估计[NE]）。托法替布组达到初始（持续）ASDAS 改善≥1.1 点的中位时间为 4（8）周，而安慰剂至托法替布组为 24（24）周，两种治疗方法的改善≥2.0 点的中位时间均为 NE。
与安慰剂至托法替布相比，托法替布治疗可更快速地改善 AS 的核心领域。约一半的接受托法替布治疗的 AS 患者在第 1 个月（M）内可能会经历≥30%的疼痛改善和 ASDAS 改善≥1.1 点，在第 2 个月（M2）内经历≥50%的夜间疼痛和附着点炎改善，在第 3 个月（M3）内经历晨僵改善。结果表明，尽早开始托法替布治疗与延迟治疗相比，可更快地改善 AS 的核心领域。
ClinicalTrials.gov，NCT03502616，2018 年 4 月 11 日。
