Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands
Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.
RMD Open. 2022 Jul;8(2). doi: 10.1136/rmdopen-2022-002280.
Long-term safety and efficacy of upadacitinib in patients with active ankylosing spondylitis (AS) has not been previously reported.
In SELECT-AXIS 1, patients receiving placebo were switched to upadacitinib 15 mg once daily at week 14 while patients initially randomised to upadacitinib continued their regimen through week 104. Efficacy was assessed using as-observed (AO) and non-responder imputation (NRI).
Of 187 patients randomised, 144 patients (77%) completed week 104. Among patients receiving continuous upadacitinib, 85.9% (AO) and 65.6% (NRI) achieved Assessment of SpondyloArthritis international Society 40 response (ASAS40) at week 104. Similar magnitude of ASAS40 responses were observed among patients who switched from placebo to upadacitinib (88.7% and 63.8%, respectively). The mean change from baseline to week 104 in Spondyloarthritis Research Consortium of Canada MRI spine and sacroiliac joint inflammation scores were -7.3 and -5.3, respectively, in the continuous upadacitinib group and -7.9 and -4.9 in the placebo-to-upadacitinib switch group. The mean (95% CI) change from baseline to week 104 in the modified Stoke Ankylosing Spondylitis Spine Score was 0.7 (0.3, 1.1) in the total group. Adverse event rate was 242.7/100 patient-years. No serious infections, adjudicated major adverse cardiovascular events, lymphoma, non-melanoma skin cancer, or gastrointestinal perforations were observed.
Upadacitinib 15 mg once daily showed sustained and consistent efficacy over 2 years for ASAS40 and other clinically relevant endpoints. A low rate of radiographic progression was observed and no new safety findings were observed.
乌帕替尼治疗活动期强直性脊柱炎（AS）患者的长期安全性和疗效此前尚未报道。
在 SELECT-AXIS 1 中，接受安慰剂的患者在第 14 周转换为乌帕替尼 15mg 每日一次，而最初随机分配至乌帕替尼的患者则继续治疗至第 104 周。采用观察到的（AO）和非应答者校正（NRI）评估疗效。
187 名随机患者中，144 名（77%）完成了第 104 周。接受连续乌帕替尼治疗的患者中，85.9%（AO）和 65.6%（NRI）在第 104 周时达到了强直性脊柱炎国际评估协会 40 应答（ASAS40）。从安慰剂转换为乌帕替尼的患者也观察到类似程度的 ASAS40 应答（分别为 88.7%和 63.8%）。连续乌帕替尼组的加拿大脊柱炎研究协会 MRI 脊柱和骶髂关节炎症评分从基线到第 104 周的平均变化分别为-7.3 和-5.3，安慰剂至乌帕替尼转换组分别为-7.9 和-4.9。总人群中，改良 Stoke 强直性脊柱炎脊柱评分从基线到第 104 周的平均（95%CI）变化为 0.7（0.3，1.1）。不良事件发生率为 242.7/100 患者年。未观察到严重感染、裁定的主要不良心血管事件、淋巴瘤、非黑色素瘤皮肤癌或胃肠道穿孔。
乌帕替尼 15mg 每日一次治疗强直性脊柱炎 2 年，可持续、一致地达到 ASAS40 及其他有临床意义的终点。观察到放射学进展率较低，且未发现新的安全性问题。
