ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2880

Secukinumab Improves Axial Manifestations in Patients with Psoriatic Arthritis and Inadequate Response to NSAIDs: Primary Analysis of Phase 3 Trial

Xenofon Baraliakos1, Laura Coates 2, Laure Gossec 3, Slawomir Jeka 4, Antonio Mera 5, Barbara Schulz 6, Michael Rissler 6, Ayan Das Gupta 7, Chiara Perella 6 and Effie Pournara 8, 1Rheumatology Department, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany, 2University of Oxford, Oxford, United Kingdom, 3Sorbonne Université and Hôpital Pitié-Salpêtrière, Paris, France, 4University Hospital Bydgoszcz no 2, CM UMK, Bydgoszcz, Poland, 5Division of Rheumatology, Instituto de Investigación Sanitaria-Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain, Santiago de Compostela, Spain, 6Novartis Pharma AG, Basel, Switzerland, 7Novartis Healthcare Pvt Ltd, Hyderabad, India, 8Novartis Pharma AG, Basel, Basel-Stadt, Switzerland

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , ,

Session Information

Date: Wednesday, November 13, 2019

Title: 6W014: Spondyloarthritis Including Psoriatic Arthritis – Clinical VII: Psoriatic Arthritis Treatment (2876–2881)

Session Type: ACR Abstract Session

Session Time: 9:00AM-10:30AM

Background/Purpose: Secukinumab (SEC) has provided significant and sustained improvement in the signs and symptoms of active psoriatic arthritis (PsA) and ankylosing spondylitis1. Evidence is limited on the efficacy of biologics in the treatment of patients (pts) with PsA having axial manifestations that affect between 30–70% of pts2, particularly as validated classification criteria for this subtype of PsA are not yet available; an effort to develop criteria is being undertaken by ASAS/GRAPPA. MAXIMISE is an ongoing study evaluating the efficacy and safety of secukinumab 300 mg or 150 mg in managing axial manifestations in pts with PsA. Here, we report the primary analysis results at Week (Wk) 12 from the MAXIMISE trial (NCT02721966).

Methods: This phase 3b, double blind, placebo (PBO)-controlled, multicenter 52-wk trial included 498 pts (aged ≥18 years) with PsA (CASPAR criteria), clinician-diagnosed axial involvements, spinal pain VAS > 40/100 and BASDAI > 4 despite trial of at least two NSAIDs. Pts were randomized to subcutaneous (SC) SEC (300/150 mg) or PBO weekly for 4 wks and every 4 wks thereafter. At Wk 12, PBO pts were re-randomized to SC SEC 300/150 mg. The primary endpoint was ASAS20 response with SEC 300 mg at Wk 12. The key secondary endpoint was ASAS20 response with SEC 150 mg at Wk 12 after superiority of 300 mg was established. Analyses used multiple imputation.

Results: Demographic and baseline (BL) disease characteristics were comparable across groups (Table). Primary and key secondary endpoints were met; ASAS20 response rates at Wk 12 were 63.1% (SEC 300 mg; P< 0.0001) and 66.3% (150 mg; P< 0.0001) versus 31.3% (PBO; Figure). ASAS20 responses in pts using concomitant methotrexate (MTX) were 65.1% [300 mg], 67.3% [150 mg] versus 33.9% [PBO]; corresponding values in pts without concomitant MTX use were 60.5%, 64.4% versus 27.1%. The safety profile was similar across groups through Wk 12.

Conclusion: MAXIMISE is the first randomized controlled trial evaluating the efficacy of a biologic in the management of the axial manifestations of psoriatic arthritis. Secukinumab 300 mg and 150 mg provided rapid and significant improvement in ASAS20 responses through Week 12 in patients with psoriatic arthritis with axial manifestations and inadequate responses to NSAIDs.

References:

    1. Lubrano E and Perrotta FM. Ther Clin Risk Manag. 2016;12:1587-92
    2. Feld J, et al. Rheum Rev.2018;14:363


Figure

Figure: ASAS20 Response rate through Week 12 -Full Analysis Set-


Table

Table: Demographic and Baseline Disease Characteristics

Disclosure: X. Baraliakos, AbbVie, 2, 4, 5, 8, Biocad, 2, 5, Bristol-Myers Squibb, 2, 4, 5, 8, Celgene, 2, 5, 8, Chugai, 2, 5, Eli Lilly, 2, 5, Galapagos, 2, 5, 8, Janssen, 2, 5, 8, Lilly, 2, 5, 8, MSD, 2, 5, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Roche, 2, 5, UCB, 2, 5, 8; L. Coates, Abbvie, 2, 5, 8, AbbVie, 2, 5, 8, AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Prothena, Sun Pharma, UCB, 5, Abbvie, Amgen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB, 5, Abbvie, Amgen, Lilly, Novartis, Pfizer, UCB, 8, AbbVie, Celgene Corporation, Eli Lilly, Janssen, Novartis, UCB, 8, AbbVie, Celgene Corporation, Eli Lilly, Novartis, Pfizer, 2, AbbVie, Celgene Corporation, Novartis, Pfizer, 2, Abbvie, Celgene, Novartis, Pfizer, Lilly, 2, Amgen, 5, 8, Biogen, 8, Bristol-Myers Squibb, 5, Celgene, 2, 5, 8, Eli Lilly, 2, 5, 8, Galapagos, 5, Gilead, 5, Janssen, 2, 5, 8, Janssen Research & Development, LLC, Lilly, 2, 5, 8, MSD, 5, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Pfizer Inc, 2, 5, 8, Prothena, 5, Sun Pharma, 5, UCB, 5, 8, UCB Pharma, 5; L. Gossec, Abbvie, 5, AbbVie, 5, Abbvie, Biogen, BMS, Celgene, Lilly, Novartis, Pfizer, SAnofi-Aventis, UCB, 5, Amgen, 5, Biogen, 5, BMS, 2, 5, Celgene, 5, Celgene Corporation, 2, Janssen, 5, Lilly, 2, 5, MSD, 5, Nordic Pharma, 5, Novartis, 5, Pfizer, 2, 5, Sanofi, 5, Sanofi-Aventis, 5, UCB, 5; S. Jeka, None; A. Mera, None; B. Schulz, Novartis, 3; M. Rissler, Novartis, 3; A. Das Gupta, Novartis, 3; C. Perella, Novartis, 3; E. Pournara, Novartis, 3.

To cite this abstract in AMA style:

Baraliakos X, Coates L, Gossec L, Jeka S, Mera A, Schulz B, Rissler M, Das Gupta A, Perella C, Pournara E. Secukinumab Improves Axial Manifestations in Patients with Psoriatic Arthritis and Inadequate Response to NSAIDs: Primary Analysis of Phase 3 Trial [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/secukinumab-improves-axial-manifestations-in-patients-with-psoriatic-arthritis-and-inadequate-response-to-nsaids-primary-analysis-of-phase-3-trial/. Accessed .

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