ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1366

Secukinumab Improved Signs and Symptoms in Patients with Non-radiographic Axial Spondyloarthritis: Results from a Randomized Controlled Phase III Study Stratified by Baseline Objective Signs of Inflammation

Juergen Braun1, Ricardo Blanco2, Helena Marzo-Ortega3, Lianne Gensler4, Filip Van den Bosch5, Hideto Kameda6, Denis Poddubnyy7, Marleen van de Sande8, Anna Wiksten9, Brian Porter10, Santiago Moreno9, Abhijit Shete9, Hanno Richards9, Sibylle Haemmerle9 and Atul Deodhar11, 1Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, 44649 Herne, Germany, 2Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain, 3The University of Leeds, Leeds Institute for Rheumatic and Musculoskeletal Medicine, NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK, Leeds, United Kingdom, 4University of California San Francisco, San Francisco, CA, 5Ghent University Hospital, Ghent, Belgium, 6Toho University, Tokyo, Japan, 7Charité – Universitätsmedizin Berlin, Berlin, Germany, 8Amsterdam UMC, AMC/University of Amsterdam, Department of Rheumatology and Clinical Immunology, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology and Immunology Center (ARC), Amsterdam, Netherlands, 9Novartis Pharma AG, Basel, Switzerland, 10Novartis Pharmaceuticals Corporation, East Hanover, NJ, 11Oregon Health & Science University, Portland, OR

Meeting: ACR Convergence 2020

Keywords: , , , ,

Session Information

Date: Sunday, November 8, 2020

Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster III

Session Type: Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Active non-radiographic axial spondyloarthritis (nr-axSpA) is often determined on the basis of objective signs of inflammation (elevated C-reactive protein [CRP] and/or evidence of sacroiliitis on MRI).1 Secukinumab (SEC) significantly improved signs and symptoms in patients (pts) with nr-axSpA in the PREVENT study (NCT02696031).2 Here, we report a pre-planned exploratory analyses of the efficacy of SEC from PREVENT stratified by CRP and MRI status (positive and/or negative) at study entry.

Methods: Pts (555) fulfilling ASAS criteria for axSpA plus abnormal CRP and/or MRI, without evidence of radiographic changes in sacroiliac joints according to modified New York Criteria for AS were enrolled. All images were assessed centrally before inclusion. Pts were randomized (1:1:1) to subcutaneous SEC 150 mg with loading (LD), without loading (NL), or placebo (PBO) at baseline (BL), Weeks (Wks) 1, 2, 3, and 4, then every 4 wks (q4wk). NL pts received SEC 150 mg at BL and PBO at Wks 1, 2, 3, and 4, then 150 mg q4wk. Exploratory efficacy assessments by CRP and MRI status (positive and/or negative) at Wk 16 included ASAS40, BASDAI50, ASAS-partial remission (PR), and ASDAS-CRP inactive disease (ID) responses. Missing values were imputed as non-response.

Results: Response rates for ASAS40, BASDAI50, ASAS-PR, and ASDAS-CRP ID with SEC 150 mg LD or NL by CRP and MRI status are shown in the Table. Numerically higher response rates for SEC were observed vs PBO for all endpoints across subgroups with the most notable differences vs PBO observed for ASAS-PR and ASDAS-CRP ID.

Conclusion: SEC provided numerically higher response rates vs PBO in pts with nr-axSpA across CRP and/or MRI positive subgroups.  

References:

  1. Lockwood MM and Gensler LS. Best Pract Res Clin Rheumatol. 2017;31:816−829.
  2. Deodhar A et al. Arthritis Rheumatol. 2019;71 (suppl 10):L21.

Summary of efficacy results at Week 16

Disclosure: J. Braun, AbbVie, 2, 5, 8, Amgen, 2, 5, 8, BMS, 2, 5, 8, Boehringer, 2, 5, 8, Celgene, 2, 5, 8, Celltrion, 2, 5, 8, Centocor, 2, 5, 8, Chugai, 2, 5, 8, EBEWE Pharma, 5, 8, Medac, 2, 5, 8, MSD, 2, 5, 8, Mundipharma, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Roche, 2, 5, 8, Sanofi-Aventis, 2, 5, 8, UCB, 2, 5, 8; R. Blanco, AbbVie, 2, 5, 8, MSD, 2, 5, 8, Roche, 2, 5, 8, Pfizer, 5, 8, Bristol-Myers Squibb, 5, 8, Janssen, 5, 8, Eli Lilly, 5, 8, UCB Pharma, 5, 8; H. Marzo-Ortega, Novartis, 2, 5, 8, Janssen, 2, 5, 8, Eli Lilly, 5, 8, Pfizer, 5, 8, UCB, 5, 8, AbbVie Inc., 5, 8, Celgene, 5, 8, Takeda Pharmaceutical Company, 5, 8; L. Gensler, AbbVie, 5, GlaxoSmithKline, 5, Eli Lilly, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB Pharma, 2, 5; F. Van den Bosch, AbbVie, 5, 8, Celgene, 5, 8, Eli Lilly, 5, 8, Galapagos, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, UCB, 5, 8, Gilead, 5, Merck, 5, 8; H. Kameda, Abbvie, 1, 2, 3, Asahi-Kasei, 2, 5, 8, Chugai, 1, 2, Eisai, 2, Mitsubishi-Tanabe, 1, 2, Novartis, 1, 2, 3, Eli Lilly, 1, 2, Janssen, 1, 2, Sanofi, 5, 8, UCB, 1, Pfizer, 1, Astellas Pharma Inc., 2, 5, 8, Gilead Sciences, 5, 8, Bristol-Myers Squibb, 8; D. Poddubnyy, Eli Lilly and Company, 2, 5, 8, MSD, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, BioCad, 5, Gilead, 5, GSK, 5, UCB, 5, 8, BMS, 8; M. van de Sande, Boehringer Ingelheim, 2, AbbVie, 5, Eli Lilly, 2, 5, MSD, 5, 8, Janssen, 2, Novartis, 2, 5, 8; A. Wiksten, Novartis, 1, 3; B. Porter, Novartis, 1, 3; S. Moreno, Novartis, 1, 3; A. Shete, Novartis, 1, 3; H. Richards, Novartis, 1, 3; S. Haemmerle, Novartis, 1, 2; A. Deodhar, AbbVie, 2, 5, Eli Lilly, 2, 5, GlaxoSmithKline, 2, 5, Novartis, 2, 5, Janssen, 5, Pfizer, 2, 5, Boehringer Ingelheim, 5, UCB Pharma, 2, 5, Amgen Inc., 5, Celgene, 5, Galapagos, 5, Bristol-Myers Squibb, 2.

To cite this abstract in AMA style:

Braun J, Blanco R, Marzo-Ortega H, Gensler L, Van den Bosch F, Kameda H, Poddubnyy D, van de Sande M, Wiksten A, Porter B, Moreno S, Shete A, Richards H, Haemmerle S, Deodhar A. Secukinumab Improved Signs and Symptoms in Patients with Non-radiographic Axial Spondyloarthritis: Results from a Randomized Controlled Phase III Study Stratified by Baseline Objective Signs of Inflammation [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/secukinumab-improved-signs-and-symptoms-in-patients-with-non-radiographic-axial-spondyloarthritis-results-from-a-randomized-controlled-phase-iii-study-stratified-by-baseline-objective-signs-of-inflam/. Accessed .

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