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.
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Authors | Robert Landewé, Désirée van der Heijde, Maxime Dougados, Xenofon Baraliakos, Filip Van den Bosch, Karl Gaffney, Lars Bauer, Bengt Hoepken, Natasha de Peyrecave, Karen Thomas, Lianne S Gensler |
Journal | Rheumatology and therapy
(Rheumatol Ther)
Vol. 7
Issue 3
Pg. 581-599
(Sep 2020)
ISSN: 2198-6576 [Print] England |
PMID | 32529495
(Publication Type: Journal Article)
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