ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2564

Secukinumab Efficacy in Psoriatic Arthritis: Individual Patient Meta-Analysis of Four Phase 3 Trials in 2049 Patients

Alice B Gottlieb1, Philip J. Mease2, Bruce Kirkham3, Peter Nash4, Alejandro Balsa5, Bernard Combe6, Juergen Rech7, Ruvie Martin8, Gregory Ligozio8, Ken Abrams8 and Luminita Pricop9, 1Department of Dermatology, New York Medical College, Metropolitan Hospital, New York, NY, 2Swedish Medical Center and University of Washington, Seattle, WA, 3Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom, 4University of Queensland, Brisbane, Australia, 5Rheumatology, Hospital La Paz - IdiPAZ, Madrid, Spain, 6Rheumatology, CHU Montpellier, Montpellier University, Montpellier, France, 7Universitätsklinikum Erlangen, Erlangen, Germany, 8Novartis Pharmaceuticals Corporation, East Hanover, NJ, 9Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords:

Session Information

Date: Tuesday, October 23, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

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

Background/Purpose: Secukinumab provided rapid, significant and sustained improvement in the signs and symptoms of psoriatic arthritis (PsA) in multiple Phase 3 studies.1-4 Herein, we report individual patient meta-analysis data for secukinumab on achievement of high hurdle efficacy endpoints versus placebo (PBO) at Week (Wk) 16 in patients (pts) with PsA from four Phase 3 studies: FUTURE 2, 3, 4 and 5. Analyses in subgroups by baseline (BL) disease activity, BL psoriasis, prior Anti‒TNF and concomitant Methotrexate (MTX) use were also evaluated.

Methods: Overall, 397, 414, 341, and 996 pts with active PsA were randomized in FUTURE 2, 3, 4, and 5 studies, respectively. Secukinumab doses included subcutaneous 300 mg and 150 mg administered at BL with loading doses (LD) at Wks 1, 2, and 3, followed by maintenance dose every 4 wks (q4w) starting at Wk 4. Data collected up to Wk 16 were pooled. Assessments included: ACR 50/70/PASI90 responses, PASDAS-Low Disease Activity (PASDAS-LDA), and Minimal Disease Activity (MDA) in overall population. ACR 50/70 and PASI 90 responses by BL Disease Activity Score (DAS) 28- C-Reactive Protein (CRP) (≤ 5.1 and > 5.1), BL CRP (≤ 10 mg/L and > 10 mg/L), BL Body Surface Area (BSA) (≥ 3%-<10%, and ≥ 10%) with psoriasis and prior Anti‒TNF and concomitant MTX use were also assessed. Results are reported after application of non-responder imputation.

Results: A total of 2049 pts were included in the meta-analysis, of which 461, 572, 335, and 681 pts received secukinumab 300mg, 150mg, 150mg without LD and PBO, respectively. Improvements were observed with secukinumab (300 mg, 150 mg, and 150 mg without LD) vs PBO for all endpoints at Wk 16 in the overall population (Figure 1) and in all subgroups (data not shown). Secukinumab 300 mg was associated with greater improvements compared to the 150 mg dose for all endpoints in overall population and in subgroups.

Conclusion: Secukinumab provided improvements in high hurdle efficacy endpoints in patients with active PsA in the overall population and in subgroups with various levels of baseline disease activity and psoriasis. Secukinumab 300 mg was associated with higher responses compared to secukinumab 150 mg across all endpoints and in all groups.

References:

1.     McInnes IB, et al. Rheumatology (Oxford) 2017; 56: 1993-2003.

2.     Nash P, et al. Arthritis Res Ther. 2018; 20: 47.

3.     Kivitz A, et al. J Clinical Rheumatol. 2018; 24 (suppl 3).

4.     Mease P, et al. Arthritis Rheumatol. 2017; 69 (suppl 10).

 

Figure 1. Responses of High Hurdle Endpoints at Week 16 in Overall Population

 

 

 

Disclosure: A. B. Gottlieb, Janssen, Incyte, UCB, Novartis, and Eli Lilly and Company, 2,Janssen, Celgene, Bristol-Myers Squibb, Beiersdorf, Inc., AbbVie, UCB, Novartis, Incyte, Eli Lilly, Reddy Labs, Valeant, Dermira, Allergan, and Sun Pharmaceutical Industries, 5, 8, 9; P. J. Mease, AbbVie Inc., 2, 5, 8,Amgen Inc., 2, 5, 8,Bristol-Myers Squibb, 2, 5, 8,Celgene Corporation, 2, 5, 8,Crescendo Bioscience, 2, 5, 8,Genentech, Inc., 2, 5, 8,Janssen, 2, 5, 8,Lilly, 2, 5, 8,Merck & Co., 2, 5, 8,Novartis, 2, 5, 8,Pfizer, Inc., 2, 5, 8,UCB, Inc., 2, 5, 8; B. Kirkham, AbbVie Inc., 2, 5, 9,Bristol-Myers Squibb, 2, 5, 9,Celgene Corporation, 2, 5, 9,Janssen, 2, 5, 8, 9,Lilly, 2, 5, 9,MSD, 2, 5, 8, 9,Novartis, 2, 5, 9,Roche, 2, 5, 9,UCB, Inc., 2, 5, 9; P. Nash, Novartis, 2, 9,AbbVie Inc., 2, 9,Roche, 2, 9,Pfizer, Inc., 2, 9,Bristol-Myers Squibb, 2, 9,Celgene Corporation, 2, 9,Janssen, 2, 9; A. Balsa, AbbVie Inc., 2, 5, 9,Bristol-Myers Squibb, 2, 5, 9,Lilly, 2, 5, 9,Pfizer, Inc., 2, 5, 9,MSD, 9,Novartis, 2, 5, 9,Roche, 2, 5, 9,UCB, 9,Sanofi, 2, 5, 9,Nordic, 2, 5, 9,Celltrion, 2, 5, 9; B. Combe, Pfizer, MSD, Roche-Chugai, 2,Pfizer, UCB, Bristol-Myers Squibb, Janssen, Eli Lilly and Company, MSD, Roche-Chugai, AbbVie, Novartis, 5,Pfizer, Bristol-Myers Squibb, Eli Lilly and Company, MSD, 8; J. Rech, Bristol-Myers Squibb, 2, 8,Celgene Corporation, 2, 8,AbbVie Inc., 8,Fresenius, 8,Medicap, 8,MSD, 8,Pfizer, Inc., 8,Roche, 8; R. Martin, Novartis, 1, 3; G. Ligozio, Novartis, 1, 3; K. Abrams, Novartis, 1, 3; L. Pricop, Novartis, 1, 3.

To cite this abstract in AMA style:

Gottlieb AB, Mease PJ, Kirkham B, Nash P, Balsa A, Combe B, Rech J, Martin R, Ligozio G, Abrams K, Pricop L. Secukinumab Efficacy in Psoriatic Arthritis: Individual Patient Meta-Analysis of Four Phase 3 Trials in 2049 Patients [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/secukinumab-efficacy-in-psoriatic-arthritis-individual-patient-meta-analysis-of-four-phase-3-trials-in-2049-patients/. Accessed .

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