Secukinumab Provides Sustained Improvement of Enthesitis in Ankylosing Spondylitis Patients: A Pooled Analysis of Four Pivotal Phase 3 Trials

Georg Schett¹, Xenofon Baraliakos ², Filip Van den Bosch ³, Atul Deodhar ⁴, Lianne Gensler ⁵, Mikkel Østergaard ⁶, Shital Agawane ⁷, Ayan Das Gupta ⁷, Shephard Mpofu ⁸, Todd Fox ⁸, Adam Winseck ⁹, Brian Porter ⁹ and Abhijit Shete ⁸, ¹Department of Internal Medicine 3, Friedrich Alexander University Erlangen-Nuremberg, Erlangen, Germany, ²Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, Herne, Germany, ³Ghent University Hospital, Ghent, Belgium, ⁴Oregon Health & Science University, Portland, OR, ⁵University San Francisco California, San Francisco, CA, ⁶Copenhagen Center for Arthritis Research, University of Copenhagen, Copenhagen, Denmark, ⁷Novartis Healthcare Pvt Ltd, Hyderabad, India, ⁸Novartis Pharma AG, Basel, Switzerland, ⁹Novartis Pharmaceuticals Corporation, East Hanover, NJ

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Ankylosing spondylitis (AS), axial spondyloarthritis, Enthesitis, interleukins (IL) and monoclonal antibodies

Session Information

Date: Monday, November 11, 2019

Session Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

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

Background/Purpose: Enthesitis can be a debilitating spondyloarthritis (SpA) manifestation and the cause of pain, reduced quality of life and impaired physical function.^1,2 Herein, we evaluated the effect of secukinumab on axial and peripheral enthesitis in ankylosing spondylitis (AS) patients with baseline enthesitis (BLE) across all Maastricht AS EnthesiS (MASES) sites (N=13), axial sites [N=11; 13 MASES minus Achilles tendons (AT); AxS] and peripheral sites (N=6; AT + lateral condyles of humerus/femur; PS) and the AT (N=2) at Weeks 16 and 52.

Methods: This post hoc analysis pooled data across 4 secukinumab studies in AS (MEASURE 1-4) from patients originally randomized to secukinumab 150mg (approved dose in AS), 300mg (MEASURE 3 only), or placebo (PBO) with BLE (MASES >0). Study designs have been reported previously.^3-5 Evaluations include mean change from BL in MASES, complete resolution (CR; MASES=0) and improvement from BL in MASES score of ≥5 counts. Mixed-effect model repeat measurement (MMRM) analysis was done on change from BL in MASES score and non-responder imputation for resolution of enthesitis at Week 16; data are reported as observed at Week 52.

Results: A total of 355 (70.4%), 58 (76.3%), and 280 (72%) patients had BLE in 150mg, 300mg and PBO groups, respectively. BL characteristics were generally comparable across groups. At Week 16, mean change from BL for overall MASES and AxS was greater for secukinumab 150mg (-2.4 and -2.3; both p< 0.05) and 300mg (-2.9 and -2.9; both p< 0.01) vs PBO (-1.9 and -1.8). At Week 16, patients treated with secukinumab 150mg (40.8% and 42.7%) and 300mg (36.2% and 42.1%) vs PBO (28.9% and 30.1%) achieved CR of enthesitis based on overall MASES and at AxS, respectively. A higher proportion of patients treated with secukinumab 150/300mg vs PBO achieved a higher threshold of improvement (≥5 counts) in overall MASES at Week 16. Further improvements were observed for all endpoints at Week 52 (Table).

Conclusion: Secukinumab 150mg and 300mg were associated with higher mean change in MASES and complete resolution of enthesitis at overall MASES and axial sites compared to placebo in AS patients at Week 16, which further increased through Week 52.

Table

Disclosure: G. Schett, AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, 8, AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, UCB, 5, BMS, Celgene, GSK, Lilly, Novartis, 2; X. Baraliakos, AbbVie, 2, 5, 8, Abbvie, 2, 5, 8, BMS, 2, 5, 8, 9, Bristol-Myers Squibb, 2, 5, 8, Celgene, 2, 5, 8, 9, Chugai, 2, 5, 8, 9, Janssen, 2, 5, 8, 9, Lilly, 2, 8, 9, Merck, 2, 5, 8, MSD, 2, 5, 8, 9, Novartis, 2, 5, 8, 9, Novatis, 2, 5, 8, Pfizer, 2, 5, 8, 9, UCB, 2, 5, 8, 9, UCB Pharma, 2, 5, 8, Werfen, 2, 5, 8; F. Van den Bosch, AbbVie, 5, 8, Abbvie, 5, 8, AbbVie, Bristol-Myers Squibb, Celgene, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sanofi and UCB, 5, 8, ABBVIE, CELGENE, ELI LILLY, GALAPAGOS, MERCK, NOVARTIS, PFIZER, VCB, 5, 8, Bristol-Myers Squibb, 2, 5, 8, Celgene, 5, 8, Eli Lilly, 5, 8, Galapagos, 5, 8, Janssen, 5, 8, Merck, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Sanofi, 5, 8, UCB, 5, 8; A. Deodhar, AbbVie, 2, 5, 9, Abbvie, 5, 8, Abbvie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, and UCB Pharma, 5, 8, AbbVie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GSK, Galapagos, Janssen, Novartis, Pfizer and UCB, 5, AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith and Klein, Janssen, Novartis, Pfizer, UCB, 5, Amgen, 5, 8, 9, BMS, 2, 5, 8, BMS, Eli Lilly, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, UCB, 2, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, UCB Pharma, 2, Boehringer Ingelheim, 5, 8, Boehringer-Ingelheim, 5, 8, Bristol Myers Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, 8, Eli Lilly, 2, 5, 8, 9, Eli Lilly and Company, 2, 5, Eli Lilly,, 5, Eli Lilly, GSK, Novartis, Pfizer and UCB, 2, Galagagos, 5, Galapagos, 5, 8, 9, Glaxo Smith & Klein, 2, Glaxo Smith & Kline, 2, 5, 8, Glaxo Smith Klein, 5, Glaxo SmithKlein, 2, 5, GlaxoSmithKlein, 2, 5, GlaxoSmithKline, 2, 5, 8, GSK, 2, 5, Janssen, 2, 5, 8, 9, Janssen Pharmaceutica, 2, 5, Janssen Research & Development, LLC, 2, Lilly, 2, 5, Novartis, 2, 5, 8, 9, Pfizer, 2, 5, 8, 9, UCB, 2, 5, 8, 9; L. Gensler, AbbVie, 2, 5, Abbvie, 2, 9, Amgen, 2, Amgen, AbbVie and Novartis, 2, Center for Disease Control, 8, Division of Vaccine Injury Compensation, 8, Eli Lilly, 5, 9, Eli Lilly and Company, 9, Galapagos, 5, 9, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB, 5, Janssen, 5, 9, Novartis, 2, 5, 9, Pfizer, 2, 9, Spondylitis Association of America, 6, Spondyloarthritis Research and Treatment Network (SPARTAN), 6, UCB, 2, 5, 9, UCB Pharma, 2, 9; M. Østergaard, AbbVie, 2, 8, 9, Abbvie, 2, 5, 8, Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, UCB, 5, 8, Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, 5, 8, Abbvie, Celgene, Centocor, Merck, and Novartis, 2, Abbvie, Celgene, Centocor, Merck, Novartis, 2, BMS, 2, 5, 8, 9, Boehringer Ingelheim, 5, 8, Boehringer-Ingelheim, 2, 8, Boehringer-ingelheim, 9, Celgene, 2, 5, 8, Centocor, 2, Eli Lilly, 5, 8, 9, Eli Lilly and Company, 5, 8, Eli-Lilly, 2, 8, Hospira, 2, 5, 8, Janssen, 2, 5, 8, 9, Merck, 2, 5, 8, 9, Novartis, 2, 5, 8, Novo, 2, 5, 8, Novo Nordisk, 5, 8, Orion, 2, 5, 8, Pfizer, 2, 5, 8, 9, Regeneron, 2, 5, 8, Roche, 2, 5, 8, roche, 9, Sandoz, 2, 8, Sanofi, 2, 8, UCB, 2, 5, 8; S. Agawane, Novartis, 3, Novartis Healthcare Pvt Ltd, 3; A. Das Gupta, Novartis, 3; S. Mpofu, Novartis, 1, 3; T. Fox, Novartis, 3, 4; A. Winseck, Novartis, 3; B. Porter, Novartis, 1, 3; A. Shete, Novartis, 1, 3.

To cite this abstract in AMA style:

Schett G, Baraliakos X, Van den Bosch F, Deodhar A, Gensler L, Østergaard M, Agawane S, Das Gupta A, Mpofu S, Fox T, Winseck A, Porter B, Shete A. Secukinumab Provides Sustained Improvement of Enthesitis in Ankylosing Spondylitis Patients: A Pooled Analysis of Four Pivotal Phase 3 Trials [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/secukinumab-provides-sustained-improvement-of-enthesitis-in-ankylosing-spondylitis-patients-a-pooled-analysis-of-four-pivotal-phase-3-trials/. Accessed October 26, 2021.

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