Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial.
| Autor: | Poddubnyy D; 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., Pournara E; Novartis AG, Basel, Switzerland., Zielińska A; Medycyna Kliniczna, Warszawa, Poland., Baranauskaite A; Lithuanian University of Health Sciences, Kaunas, Lithuania., Jiménez AM; Hospital Universitario Virgen del Rocío, Sevilla, Spain., Sadhu S; Novartis Healthcare Private Limited, Hyderabad, India., Schulz B; Novartis AG, Basel, Switzerland., Rissler M; Novartis AG, Basel, Switzerland., Perella C; Novartis AG, Basel, Switzerland., Marzo-Ortega H; NIHR Leeds Biomedical Research Centre, LTHT and LIRMM, University of Leeds, Leeds, UK. |
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| Jazyk: | angličtina |
| Zdroj: | Therapeutic advances in musculoskeletal disease [Ther Adv Musculoskelet Dis] 2021 Oct 22; Vol. 13, pp. 1759720X211051471. Date of Electronic Publication: 2021 Oct 22 (Print Publication: 2021). |
| DOI: | 10.1177/1759720X211051471 |
| Abstrakt: | 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. Competing Interests: Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DP received grant/research support from AbbVie, MSD, Novartis, and Pfizer, and a consultant/speaker for AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche, and UCB. EP is an employee of Novartis and owns Novartis Stock. AZ is a consultant for Novartis and Pfizer. AB is a consultant for AbbVie and on the speaker’s bureau of Novartis, AbbVie, Amgen, Roche, and KRKA. SS and BS are employees of Novartis. MR and CP are employees of Novartis and own Novartis Stock. HM-O received grant/research support from Janssen and Novartis, a consultant for AbbVie, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, and UCB, and on the speaker’s bureau of AbbVie, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, Takeda, and UCB. The remaining author had no conflicts to declare. (© The Author(s), 2021.) |
| Databáze: | MEDLINE |
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