Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial
Background: 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. Methods: Patients ( n = 380) with active axSpA were random...
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2021
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oai:doaj.org-article:0aab8dcaba324ec297f20dbdc50890f52021-11-22T08:33:19ZRapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial1759-721810.1177/1759720X211051471https://doaj.org/article/0aab8dcaba324ec297f20dbdc50890f52021-10-01T00:00:00Zhttps://doi.org/10.1177/1759720X211051471https://doaj.org/toc/1759-7218Background: 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. Methods: Patients ( n = 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). Results: 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; p = 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. Conclusion: 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. Trial Registration: ClinicalTrials.gov: NCT03136861. Registered May 2, 2017.Denis PoddubnyyEffie PournaraAgnieszka ZielińskaAsta BaranauskaiteAlejandro Muñoz JiménezSanchayita SadhuBarbara SchulzMichael RisslerChiara PerellaHelena Marzo-OrtegaSAGE PublishingarticleDiseases of the musculoskeletal systemRC925-935ENTherapeutic Advances in Musculoskeletal Disease, Vol 13 (2021) |
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Diseases of the musculoskeletal system RC925-935 |
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Diseases of the musculoskeletal system RC925-935 Denis Poddubnyy Effie Pournara Agnieszka Zielińska Asta Baranauskaite Alejandro Muñoz Jiménez Sanchayita Sadhu Barbara Schulz Michael Rissler Chiara Perella Helena Marzo-Ortega Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial |
description |
Background: 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. Methods: Patients ( n = 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). Results: 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; p = 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. Conclusion: 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. Trial Registration: ClinicalTrials.gov: NCT03136861. Registered May 2, 2017. |
format |
article |
author |
Denis Poddubnyy Effie Pournara Agnieszka Zielińska Asta Baranauskaite Alejandro Muñoz Jiménez Sanchayita Sadhu Barbara Schulz Michael Rissler Chiara Perella Helena Marzo-Ortega |
author_facet |
Denis Poddubnyy Effie Pournara Agnieszka Zielińska Asta Baranauskaite Alejandro Muñoz Jiménez Sanchayita Sadhu Barbara Schulz Michael Rissler Chiara Perella Helena Marzo-Ortega |
author_sort |
Denis Poddubnyy |
title |
Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial |
title_short |
Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial |
title_full |
Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial |
title_fullStr |
Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial |
title_full_unstemmed |
Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial |
title_sort |
rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-iiib trial |
publisher |
SAGE Publishing |
publishDate |
2021 |
url |
https://doaj.org/article/0aab8dcaba324ec297f20dbdc50890f5 |
work_keys_str_mv |
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