Poddubnyy Denis, Pournara Effie, Zielińska Agnieszka, Baranauskaite Asta, Jiménez Alejandro Muñoz, Sadhu Sanchayita, Schulz Barbara, Rissler Michael, Perella Chiara, Marzo-Ortega Helena
Head of the Rheumatology Unit, Department of Gastroenterology, Infectious Diseases and Rheumatology (including Nutrition Medicine), Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.
Novartis AG, Basel, Switzerland.
Ther Adv Musculoskelet Dis. 2021 Oct 22;13:1759720X211051471. doi: 10.1177/1759720X211051471. eCollection 2021.
This study aimed to evaluate the efficacy and safety of secukinumab 150 mg compared with placebo in the management of spinal pain and disease activity in patients with axial spondyloarthritis (axSpA) at Week 8 and up to Week 24.
Patients ( = 380) with active axSpA were randomized (3:1) to secukinumab 150 mg (Group A) or placebo (Group B). At Week 8, patients from Group A with an average spinal pain score <4 were defined as responders and were re-assigned to secukinumab 150 mg (Arm A1); whereas non-responders were re-randomized to secukinumab 150/300 mg (Arm A2/A3). Patients from Group B were re-randomized (1:1) to secukinumab 150/300 mg (Arm B1/B2).
At Week 8, the odds of achieving an average spinal pain score of <4 were significantly higher for patients on secukinumab 150 mg than for patients on placebo (odds ratio (OR): 1.89; 95% confidence interval (CI): 1.08-3.33; = 0.0264). Further reductions in spinal pain were observed across treatment groups up to Week 24. Pronounced improvements were also observed in other disease activity measurements, such as Bath Ankylosing Spondylitis Disease Activity Index and Ankylosing Spondylitis Disease Activity Score. Responders from Group A showed the highest improvements for all measured parameters of spinal pain compared with the other arms. No new or unexpected safety signals were observed.
Secukinumab provided rapid and significant improvement in spinal pain at Week 8 which was sustained or increased further up to Week 24 in patients with axSpA.
ClinicalTrials.gov: NCT03136861. Registered May 2, 2017.
本研究旨在评估150mg司库奇尤单抗与安慰剂相比，在治疗第8周及直至第24周时对轴性脊柱关节炎（axSpA）患者脊柱疼痛和疾病活动的疗效及安全性。
380例活动性axSpA患者按3:1随机分为150mg司库奇尤单抗组（A组）或安慰剂组（B组）。在第8周时，A组中平均脊柱疼痛评分<4分的患者被定义为反应者，并重新分配至150mg司库奇尤单抗组（A1组）；而无反应者则重新随机分配至150/300mg司库奇尤单抗组（A2/A3组）。B组患者按1:1重新随机分配至150/300mg司库奇尤单抗组（B1/B2组）。
在第8周时，150mg司库奇尤单抗组患者平均脊柱疼痛评分<4分的几率显著高于安慰剂组（优势比（OR）：1.89；95%置信区间（CI）：1.08 - 3.33；P = 0.0264）。直至第24周，各治疗组的脊柱疼痛均进一步减轻。在其他疾病活动指标方面，如巴斯强直性脊柱炎疾病活动指数和强直性脊柱炎疾病活动评分，也观察到显著改善。与其他组相比，A组的反应者在所有测量的脊柱疼痛参数方面改善最为明显。未观察到新的或意外的安全信号。
司库奇尤单抗在第8周时能迅速显著改善axSpA患者的脊柱疼痛，这种改善在第24周时持续存在或进一步增强。
ClinicalTrials.gov：NCT03136861。于2017年5月2日注册。
