Secukinumab Efficacy on Enthesitis in Patients With Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase III Studies.


Journal

The Journal of rheumatology
ISSN: 0315-162X
Titre abrégé: J Rheumatol
Pays: Canada
ID NLM: 7501984

Informations de publication

Date de publication:
08 2021
Historique:
accepted: 26 02 2021
pubmed: 17 3 2021
medline: 25 2 2023
entrez: 16 3 2021
Statut: ppublish

Résumé

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. 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. 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 ( Secukinumab improved enthesitis at overall MASES and axial sites in patients with AS.

Identifiants

pubmed: 33722947
pii: jrheum.201111
doi: 10.3899/jrheum.201111
doi:

Substances chimiques

Antibodies, Monoclonal 0
Antibodies, Monoclonal, Humanized 0
secukinumab DLG4EML025

Banques de données

ClinicalTrials.gov
['NCT01649375', 'NCT01358175', 'NCT02159053', 'NCT02008916']

Types de publication

Clinical Trial, Phase III Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1251-1258

Informations de copyright

© 2021 The Journal of Rheumatology.

Auteurs

Georg Schett (G)

G. Schett, MD, Department of Internal Medicine, Friedrich Alexander University Erlangen-Nuremberg, Erlangen, Germany; Georg.Schett@uk-erlangen.de.

Xenofon Baraliakos (X)

X. Baraliakos, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Germany.

Filip Van den Bosch (F)

F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, and VIB Center for Inflammation Research, Ghent, Belgium.

Atul Deodhar (A)

A. Deodhar, MD, Oregon Health & Science University, Portland, Oregon, USA.

Mikkel Østergaard (M)

M. Østergaard, MD, PhD, Copenhagen Center for Arthritis Research, University of Copenhagen, Copenhagen, Denmark.

Ayan Das Gupta (AD)

A. Das Gupta, PhD, Novartis Healthcare Pvt. Ltd., Hyderabad, India.

Shephard Mpofu (S)

S. Mpofu, MD, T. Fox, RPh, PharmB, ACPR, A. Shete, MD, Novartis Pharma AG, Basel, Switzerland.

Todd Fox (T)

S. Mpofu, MD, T. Fox, RPh, PharmB, ACPR, A. Shete, MD, Novartis Pharma AG, Basel, Switzerland.

Adam Winseck (A)

A. Winseck, PhD, B. Porter, MD, PhD, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.

Brian Porter (B)

A. Winseck, PhD, B. Porter, MD, PhD, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.

Abhijit Shete (A)

S. Mpofu, MD, T. Fox, RPh, PharmB, ACPR, A. Shete, MD, Novartis Pharma AG, Basel, Switzerland.

Lianne S Gensler (LS)

L.S. Gensler, MD, University of California, San Francisco, University of California, California, USA.

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Classifications MeSH