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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Autores principales: Denis Poddubnyy, Effie Pournara, Agnieszka Zielińska, Asta Baranauskaite, Alejandro Muñoz Jiménez, Sanchayita Sadhu, Barbara Schulz, Michael Rissler, Chiara Perella, Helena Marzo-Ortega
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Publicado: SAGE Publishing 2021
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spelling 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)
institution DOAJ
collection DOAJ
language EN
topic Diseases of the musculoskeletal system
RC925-935
spellingShingle 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
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