ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2853

Secukinumab Improves Skin Symptoms and Physical Functioning Compared with Ustekinumab in Patients with Moderate to Severe Psoriasis with Concomitant Psoriatic Arthritis: Subanalysis of a Randomized, Double Blind, Parallel-Group, Active Comparator-Controlled Phase 3b Trial

Alice B. Gottlieb1, Diamant Thaci2, Andrew Blauvelt3, Marina Milutinovic4 and Shephard Mpofu4, 1Tufts Medical Center and Tufts University School of Medicine, Boston, MA, 2Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany, 3Research Excellence & Personalized Patient Care, Oregon Medical Research Center, Portland, OR, 4Novartis Pharma AG, Basel, Switzerland

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: , , ,

Session Information

Date: Tuesday, November 10, 2015

Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy

Session Type: ACR Poster Session C

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

Background/Purpose: Psoriatic arthritis (PsA) is a common comorbidity in patients (pts) with psoriasis. In the ongoing Phase 3b CLEAR study (NCT02074982), secukinumab, a fully human anti-interleukin (IL)-17A monoclonal antibody, demonstrated superior efficacy (PASI 90) to ustekinumab (an IL-12/23 inhibitor) in pts with moderate to severe plaque psoriasis.1Here we report results of a pre-defined sub-analysis which evaluated 16-week (wk) outcomes in pts in the study who had concomitant PsA.

Methods: Pts, stratified by body weight (≤ 100 and > 100 kg), were randomized 1:1 to receive subcutaneous (s.c.) secukinumab 300 mg or ustekinumab (for pts ≤ 100 kg, 45 mg s.c.; > 100 kg, 90 mg s.c.). Secukinumab was administered at baseline (BL), Wks 1, 2, 3, and every 4 Wks from Wk 4; ustekinumab was administered at BL and Wk 4, and then every 12 wks from Wk 16. The primary end-point was the proportion of pts achieving at least a 90% reduction from BL in Psoriasis Area and Severity Index score (PASI 90) at Wk 16. Changes from BL in the Health Assessment Questionnaire-Disability Index (HAQ-DI; score range of 0–3) were reported in the subgroup of psoriasis pts with concomitant PsA.

Results: The overall study population consisted of 676 pts. Concomitant PsA was reported in 69/337 (20.5%) pts in the secukinumab group and 54/339 (15.9%) pts in the ustekinumab group. In the overall population, a PASI 90 response at Wk 16 was achieved by 79.0% pts receiving secukinumab vs. 57.6% pts receiving ustekinumab (P < 0.0001) and a PASI 100 (clear skin) response at Wk 16 was achieved by 44.3% pts receiving secukinumab vs. 28.4% pts receiving ustekinumab (P < 0.0001). In the subgroup of pts with concomitant PsA, a higher proportion of pts in the secukinumab group achieved a PASI 90 response at Wk 16 compared with ustekinumab; 79.1% vs. 65.4%, respectively (p=0.063). A PASI 100 response at Wk 16 was achieved by 35.8% pts in the secukinumab group vs. 28.8% pts in the ustekinumab group (p=0.336). Improvements in physical function in the PsA sub-group were greater with secukinumab vs. ustekinumab; mean change from baseline in HAQ-DI at Wk 16 was –0.29 (-47.6%) with secukinumab vs. –0.13 (-37.7%) with ustekinumab. A higher proportion of pts receiving secukinumab achieved a clinically meaningful improvement in HAQ-DI (defined as at least a 0.3 decrease from baseline at Wk 16 vs. ustekinumab (34.9% vs. 26.5%, respectively).

Conclusion: Secukinumab was superior to ustekinumab at improving skin symptoms in patients with moderate to severe plaque psoriasis. In the small sub-group of patients with psoriasis and concomitant PsA, secukinumab showed a trend for improving skin symptoms and physical functioning compared with ustekinumab.

Reference:

  1. Thaci D, et al. Oral Presentation at AAD Annual Meeting 2015, San Francisco, USA Late breaking abstract.
Disclosure: A. B. Gottlieb, Amgen Inc., Astellas, Akros, Centocor (Janssen), Inc. Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Abbott Labs. (Abbvie), DUSA, TEVA, Actelion, UCB, Novo Nordisk, Novartis, Dermipsor Ltd., Incyte, Pfizer, Canfite, Lilly, Coronado, Vertex, Ka, 5,Centocor (Janssen), Amgen, Abbott (Abbvie), Novartis, Celgene, Pfizer, Lilly, Coronado, Levia, Merck, Xenoport, 2; D. Thaci, AbbVie, Amgen, Biogen-Idec, Celgene Corp., Eli Lilly, Janssen-Cilag, Leo Pharma, MSD, Novartis, Pfizer, Regeneron, and Sanofi, 5,AbbVie, Amgen, Biogen-Idec, Celgene Corp., Eli Lilly, Janssen-Cilag, Leo Pharma, MSD, Novartis, Pfizer, Regeneron, and Sanofi, 6,AbbVie, Amgen, Biogen-Idec, Celgene Corp., Eli Lilly, Janssen-Cilag, Leo Pharma, MSD, Novartis, Pfizer, Regeneron, and Sanofi, 9; A. Blauvelt, Abbott, Amgen, Astellas, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, Galderma, Janssen, Merck, Novartis, Pfizer, and Sandoz, 5; M. Milutinovic, Novartis Pharmaceutical Corporation, 3; S. Mpofu, Novartis AG, 3,Novartis AG, 1.

To cite this abstract in AMA style:

Gottlieb AB, Thaci D, Blauvelt A, Milutinovic M, Mpofu S. Secukinumab Improves Skin Symptoms and Physical Functioning Compared with Ustekinumab in Patients with Moderate to Severe Psoriasis with Concomitant Psoriatic Arthritis: Subanalysis of a Randomized, Double Blind, Parallel-Group, Active Comparator-Controlled Phase 3b Trial [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/secukinumab-improves-skin-symptoms-and-physical-functioning-compared-with-ustekinumab-in-patients-with-moderate-to-severe-psoriasis-with-concomitant-psoriatic-arthritis-subanalysis-of-a-randomized-d/. Accessed .

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