Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Tw

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ORIGINAL RESEARCH

Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies Xenofon Baraliakos . Filip Van den Bosch . Pedro M. Machado . Lianne S. Gensler . Helena Marzo-Ortega . Bintu Sherif . Erhard Quebe-Fehling . Brian Porter . Corine Gaillez . Atul Deodhar Received: October 29, 2020 / Accepted: December 5, 2020 Ó The Author(s) 2020

ABSTRACT Introduction: Clinical remission in patients with ankylosing spondylitis (AS) has been determined using composite indices such as the AS Disease Activity Score inactive disease (ASDAS-ID), Assessment of SpondyloArthritis Supplementary Information The online version contains supplementary material available at https:// doi.org/10.1007/s40744-020-00269-6. X. Baraliakos (&) Rheumazentrum Ruhrgebiet Herne, RuhrUniversity Bochum, Bochum, Germany e-mail: [email protected] F. Van den Bosch Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium F. Van den Bosch VIB Center for Inflammation Research, Ghent, Belgium P. M. Machado Department of Rheumatology, University College London Hospitals NHS Foundation Trust, London, UK P. M. Machado Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare NHS Trust, London, UK P. M. Machado Centre for Rheumatology and Department of Neuromuscular Diseases, University College London, London, UK

international Society criteria partial remission (ASAS-PR), and low Bath AS Disease Activity Index (BASDAI) scores. The objective of this exploratory analysis was to evaluate the proportion of secukinumab-treated patients with AS achieving remission defined based on the ASDAS-ID (score \ 1.3), ASAS-PR or BASDAI score B 2. Methods: The analysis pooled data from the MEASURE 1 and 2 studies over 3 years. The L. S. Gensler Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, USA H. Marzo-Ortega NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK B. Sherif RTI Health Solutions, Research Triangle Park, NC, USA E. Quebe-Fehling  C. Gaillez Novartis Pharma AG, Basel, Switzerland B. Porter Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA A. Deodhar Oregon Health and Science University, Portland, OR, USA

Rheumatol Ther

proportion of patients who achieved ASDAS-ID, ASAS-PR, or BASDAI B 2 with secukinumab was compared with placebo at week 16; results for secukinumab-treated patients were summarized through week 156. Sustainability of each criterion was assessed from week 16 to 156 using shift analysis. The association between each of these criteria and specific patient-reported outcomes (PROs), such as health-related quality of life, function, fatigue, and work impairment, was also explored. Results: At week 16, a higher proportion of secukinumab-treated patients versus placebo achieved ASDAS-ID (17.6 vs. 3.5%), ASAS-PR (15.4 vs. 4.1%), or B