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

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

doi:10.1007/s40744-020-00214-7

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

Rheumatol Ther. 2020 Sep;7(3):581-599. doi: 10.1007/s40744-020-00214-7. Epub 2020 Jun 11.

Authors

Robert Landewé^{1

2}, Désirée van der Heijde³, Maxime Dougados^{4

5}, Xenofon Baraliakos⁶, Filip Van den Bosch⁷, Karl Gaffney⁸, Lars Bauer⁹, Bengt Hoepken⁹, Natasha de Peyrecave¹⁰, Karen Thomas⁹, Lianne S Gensler¹¹

Affiliations

¹ Amsterdam Rheumatology and Clinical Immunology Center, Amsterdam, The Netherlands. landewe@rlandewe.nl.
² Zuyderland Medical Center, Heerlen, The Netherlands. landewe@rlandewe.nl.
³ Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
⁴ Department of Rheumatology, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris, France.
⁵ INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France.
⁶ Ruhr-University Bochum, Herne, Germany.
⁷ Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium.
⁸ Rheumatology Department, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.
⁹ UCB Pharma, Monheim am Rhein, Germany.
¹⁰ UCB Pharma, Brussels, Belgium.
¹¹ University of California San Francisco, San Francisco, CA, USA.

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.

Keywords: Axial spondyloarthritis; Clinical remission; Early disease; TNF inhibitor.

Associated data

ClinicalTrials.gov/NCT02505542