Secukinumab efficacy on enthesitis in patients with ankylosing spondylitis: Pooled analysis of four pivotal phase III studies

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Dokumenter

  • Fulltext

    Accepteret manuskript, 2,68 MB, PDF-dokument

  • Georg Schett
  • Xenofon Baraliakos
  • Filip van den Bosch
  • Atul Deodhar
  • Østergaard, Mikkel
  • Ayan Das Gupta
  • Shephard Mpofu
  • Todd Fox
  • Adam Winseck
  • Brian Porter
  • Abhijit Shete
  • Lianne S. Gensler

Objective. To assess the efficacy of secukinumab on axial and peripheral enthesitis in patients with ankylosing spondylitis (AS) using pooled data from randomized controlled phase III studies. Methods. In this posthoc analysis, data were pooled from patients originally randomized to secukinumab 150 mg, 300 mg, or placebo (PBO) from phase III MEASURE 1-4 studies (ClinicalTrials.gov: NCT01358175, NCT01649375, NCT02008916, and NCT02159053). Maastricht AS Enthesitis Score (MASES) was used for assessments of enthesitis through Week 52. Efficacy outcomes were mean change in MASES score and complete resolution (MASES = 0) of enthesitis in patients with baseline MASES > 0. Results. A total of 693 (71.5%) patients had enthesitis at baseline in secukinumab 300 mg, 150 mg, and PBO groups (58 [76.3%], 355 [70.4%], and 280 [72%], respectively) out of 969 patients pooled in this analysis. At Week 16, mean changes from baseline for overall MASES and enthesitis at axial MASES sites, respectively, were as follows: -2.9 (P < 0.01) and -2.9 (P < 0.01) for secukinumab 300 mg; -2.4 (P < 0.015) and -2.3 (P< 0.05) for secukinumab 150 mg; and -1.9 and -1.8 for PBO, with improvements seen through Week 52. More than one-third of secukinumab-treated patients (300 mg: 36.2%; 150 mg: 40.8%) achieved complete resolution of enthesitis at Week 16. Conclusion. Secukinumab improved enthesitis at overall MASES and axial sites in patients with AS.

OriginalsprogEngelsk
TidsskriftJournal of Rheumatology
Vol/bind48
Udgave nummer8
Sider (fra-til)1251-1258
Antal sider8
ISSN0315-162X
DOI
StatusUdgivet - 2021

Bibliografisk note

Funding Information:
This study was funded by Novartis Pharma AG, Basel, Switzerland. 1G. Schett, MD, Department of Internal Medicine, Friedrich Alexander University Erlangen-Nuremberg, Erlangen, Germany; 2X. Baraliakos, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Germany; 3F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, and VIB Center for Inflammation Research, Ghent, Belgium; 4A. Deodhar, MD, Oregon Health & Science University, Portland, Oregon, USA; 5M. Østergaard, MD, PhD, Copenhagen Center for Arthritis Research, University of Copenhagen, Copenhagen, Denmark; 6A. Das Gupta, PhD, Novartis Healthcare Pvt. Ltd., Hyderabad, India; 7S. Mpofu, MD, T. Fox, RPh, PharmB, ACPR, A. Shete, MD, Novartis Pharma AG, Basel, Switzerland; 8A. Winseck, PhD, B. Porter, MD, PhD, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA; 9L.S. Gensler, MD, University of California, San Francisco, University of California, California, USA. GS has received grant/research support from BMS, Celgene, GSK, Eli Lilly, and Novartis; consultancy fees for AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, and UCB; and speakers bureau fees from AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, and Pfizer. XB has been a consultant for AbbVie, BMS, Chugai, MSD, Novartis, Pfizer, UCB, and received speakers bureau fees from AbbVie, BMS, Chugai, MSD, Novartis, Pfizer, and UCB. FVDB has received consultant/speaker fees from AbbVie, BMS, Celgene, Galapagos, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sanofi, and UCB. AD has received grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and has been a consultant for AbbVie, Amgen, Boheringer Ingelheim, Celgene, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, and UCB. LG has received grant/research support from Novartis, Pfizer, and UCB, and has been a consultant for AbbVie, Gilead, GSK, Eli Lilly, Novartis, Pfizer, and UCB. MØ has received speaker/consultant fees from AbbVie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Gilead, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB; and research grants from AbbVie, Celgene, Centocor, Merck, and Novartis. ADG is an employee of Novartis. SM, TF, AW, BP, and AS are employees and shareholders of Novartis. Address correspondence to Dr. G. Schett, Department of Internal Medicine 3 and Institute for Clinical Immunology, Friedrich Alexander University, Krankenhausstr. 12, D-91054 Erlangen, Germany. Email: Georg.Schett@uk-erlangen.de. Accepted for publication February 26, 2021.

Publisher Copyright:
© 2021 Journal of Rheumatology. All rights reserved.

ID: 301362406