Induction of Sustained Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Treatment: 48-We
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ORIGINAL RESEARCH
Induction of Sustained Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Treatment: 48-Week Outcomes from C-OPTIMISE Robert Landewe´ . De´sire´e 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 Received: April 17, 2020 Ó The Author(s) 2020
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
Digital Features To view digital features for this article go to: https://doi.org/10.6084/m9.figshare.12357767. Electronic Supplementary Material The online version of this article (https://doi.org/10.1007/s40744020-00214-7) contains supplementary material, which is available to authorized users. R. Landewe´ (&) Amsterdam Rheumatology and Clinical Immunology Center, Amsterdam, The Netherlands e-mail: [email protected] R. Landewe´ Zuyderland Medical Center, Heerlen, The Netherlands D. van der Heijde Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands M. Dougados ˆ pital Cochin, Department of Rheumatology, Ho ˆ pitaux de Paris, Universite´ de Assistance Publique-Ho Paris, Paris, France M. Dougados INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cite´, Paris, France
(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 X. Baraliakos Ruhr-University Bochum, Herne, Germany F. Van den Bosch Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium K. Gaffney Rheumatology Department, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK L. Bauer B. Hoepken K. Thomas UCB Pharma, Monheim am Rhein, Germany N. de Peyrecave UCB Pharma, Brussels, Belgium L. S. Gensler University of California San Francisco, San Francisco, CA, USA
Rheumatol Ther
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 a
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