Induction of Sustained Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Treatment: 48-Week Outcomes from C-OPTIMISE

Rheumatology and Therapy

Robert Landewé¹  Filip Van den Bosch²  Maxime Dougados³  Désirée van der Heijde⁴  Karl Gaffney⁵  Xenofon Baraliakos⁶  Natasha de Peyrecave⁷  Lars Bauer⁷  Karen Thomas⁷  Bengt Hoepken⁷  Lianne S. Gensler⁸ 

[1] Amsterdam Rheumatology and Clinical Immunology Center;Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University;Department of Rheumatology, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Université de Paris;Department of Rheumatology, Leiden University Medical Center;Rheumatology Department, Norfolk and Norwich University Hospital NHS Foundation Trust;Ruhr-University Bochum;UCB Pharma;University of California San Francisco;

关键词: Axial spondyloarthritis;    Clinical remission;    Early disease;    TNF inhibitor;   

DOI  :  10.1007/s40744-020-00214-7

来源: DOAJ

【 摘 要 】

Abstract Introduction Achievement of remission is a key treatment goal for patients with axial spondyloarthritis (axSpA). C-OPTIMISE assessed achievement of sustained clinical remission in patients with axSpA, including radiographic (r) and non-radiographic (nr) axSpA, during certolizumab pegol (CZP) treatment, and subsequent maintenance of remission following CZP dose continuation, dose reduction or withdrawal. Here, we report outcomes from the first 48 weeks (induction period) of C-OPTIMISE, during which patients received open-label CZP. Methods C-OPTIMISE (NCT02505542) was a two-part, multicenter, phase 3b study in adult patients with early axSpA (r-/nr-axSpA), including a 48-week open-label induction period followed by a 48-week maintenance period. Patients with active adult-onset axSpA, < 5 years’ symptom duration, and fulfilling Assessment of SpondyloArthritis international Society classification criteria, were included. During the induction period, patients received a loading dose of CZP 400 mg at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) up to week 48. The main outcome of the 48-week induction period was the achievement of sustained clinical remission (defined as an Ankylosing Spondylitis Disease Activity Score [ASDAS] < 1.3 at week 32 and < 2.1 at week 36 [or vice versa], and < 1.3 at week 48). Results In total, 736 patients (407 with r-axSpA, 329 with nr-axSpA) were enrolled into the study. At week 48, 43.9% (323/736) of patients achieved sustained remission, including 42.8% (174/407) of patients with r-axSpA and 45.3% (149/329) with nr-axSpA. Patients also demonstrated substantial improvements in axSpA symptoms, MRI outcomes and quality of life measures. Adverse events occurred in 67.9% (500/736) of patients, of which 6.0% (44/736) were serious. Conclusions Over 40% of patients with early axSpA achieved sustained remission during 48 weeks of open-label CZP treatment. Additionally, patients across the axSpA spectrum demonstrated substantial improvements in imaging outcomes and quality of life following treatment. No new safety signals were identified. Trial Registration NCT02505542.

【 授权许可】

Unknown