Gossec Laure, Walsh Jessica A, Sengupta Raj, Bushmakin Andrew G, Cappelleri Joseph C, Yndestad Arne, Dina Oluwaseyi, Cella David
Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.
Rheumatology, Pitie-Salpetriere Hospital, 47 Bd Hopital, 75013, Paris, France.
Rheumatol Ther. 2025 Feb;12(1):85-98. doi: 10.1007/s40744-024-00727-5. Epub 2024 Dec 13.
Fatigue is a key symptom in patients with ankylosing spondylitis (AS). The objective of this analysis was to estimate the median time to initial and stable improvement events in fatigue in patients with AS receiving tofacitinib.
This post hoc analysis used data from a phase 3 trial (NCT03502616) in patients with active AS receiving tofacitinib 5 mg twice daily or placebo. Time to improvement in fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score, experience domain score, and impact domain score. The rapidity of improvement was assessed by time-to-event analyses (nonparametric Kaplan-Meier models); initial improvement events (i.e., time to first week of FACIT-F improvement) and stable improvement events (i.e., time to first week of FACIT-F improvement, sustained to 16 weeks) were examined.
Overall, 269 patients were assessed (mean disease duration: 14.2 [standard deviation (SD): 9.8] years; mean baseline FACIT-F total score: 27.2 [SD: 9.3]). Median times to initial and stable improvement events in FACIT-F total and domain scores were significantly shorter and occurred in more patients receiving tofacitinib than placebo. Median time to initial and stable improvement events of 6 points in FACIT-F total score were 8 and 12 weeks with tofacitinib, respectively (placebo: not reached); 70.0% versus 48.5% of patients receiving tofacitinib versus placebo, respectively, experienced initial improvements of 6 points in FACIT-F total score within 16 weeks.
Improvements in fatigue occurred more rapidly with tofacitinib than with placebo. These results may be useful for healthcare providers when discussing tofacitinib treatment expectations with patients.
ClinicalTrials.gov: NCT03502616 (June 7, 2018).
疲劳是强直性脊柱炎（AS）患者的关键症状。本分析的目的是评估接受托法替布治疗的AS患者疲劳症状首次改善和稳定改善事件的中位时间。
本事后分析使用了一项3期试验（NCT03502616）的数据，该试验纳入了每日两次服用5mg托法替布或安慰剂的活动性AS患者。使用慢性病治疗功能评估-疲劳（FACIT-F）总分、体验领域得分和影响领域得分来评估疲劳改善时间。通过事件时间分析（非参数Kaplan-Meier模型）评估改善速度；检查首次改善事件（即FACIT-F改善的第一周时间）和稳定改善事件（即FACIT-F改善的第一周时间，并持续至16周）。
总体而言，共评估了269例患者（平均病程：14.2[标准差（SD）：9.8]年；平均基线FACIT-F总分：27.2[SD：9.3]）。与安慰剂相比，接受托法替布治疗的患者FACIT-F总分和领域得分首次改善和稳定改善事件的中位时间显著更短，且更多患者出现改善。FACIT-F总分提高6分的首次改善和稳定改善事件的中位时间，托法替布分别为8周和12周（安慰剂：未达到）；接受托法替布和安慰剂治疗的患者中，分别有70.0%和48.5%在16周内FACIT-F总分出现了6分的首次改善。
与安慰剂相比，托法替布能更快改善疲劳症状。这些结果可能有助于医疗保健提供者与患者讨论托法替布的治疗预期。
ClinicalTrials.gov：NCT03502616（2018年6月7日）。
