Patients with Active Psoriatic Arthritis Achieving Minimal Disease Activity with Secukinumab Treatment Demonstrate Sustained Improvement of Function and Quality of Life

Laura C. Coates¹, Philip J Mease², Laure Gossec³, Bruce Kirkham⁴, Lawrence Rasouliyan⁵, Shephard Mpofu⁶, Steffen Jugl⁶, Chetan Karyekar⁷ and Kunal Gandhi⁷, ¹University of Leeds, Leeds, United Kingdom, ²Rheumatology and Internal Medicine, Swedish Medical Center and University of Washington, Seattle, WA, ³Rheumatology Department, Hôpital Pitié Salpêtrière, Paris 06 University, Paris, France, ⁴Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom, ⁵RTI Health Solutions, Barcelona, Spain, ⁶Novartis Pharma AG, Basel, Switzerland, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Disease Activity, interleukins (IL), monoclonal antibodies and psoriatic arthritis, PRO

Session Information

Date: Monday, November 14, 2016

Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster II: Psoriatic Arthritis

Session Type: ACR Poster Session B

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

Background/Purpose: Secukinumab, a fully human anti–IL-17A monoclonal antibody, previously demonstrated higher minimal disease activity (MDA)¹ response rates and sustained improvements in patient reported outcomes² among active psoriatic arthritis (PsA) patients (pts) through Week (Wk) 52 in the FUTURE 2 study. This post-hoc analysis is further exploring the impact of secukinumab on individual components of MDA and its relationship with patient-reported outcomes among those who achieved or did not achieve MDA response through Wk 52.

Methods: 397 pts with active PsA were randomized to subcutaneous (s.c) secukinumab (300 mg, 150 mg, or 75 mg) or placebo at baseline, Wks 1, 2, and 3, and every 4 wks (q4w) from Wk 4.² Pts were considered in MDA when they met at least 5 of 7 pre-defined criteria.¹ The proportion of pts achieving each individual criterion of MDA and the proportion of pts achieving all seven criteria of MDA were calculated at Wks 24 and 52. Additionally, SF-36 MCS, SF-36 PCS, FACIT-Fatigue, PsAQoL, and DLQI were assessed in MDA responders and non-responders at Wks 24 and 52 using mixed-model for repeated measures (MMRM) analyses.

Results: In the pooled secukinumab (300 mg and 150 mg) MDA responder group, tender entheseal points ≤1 (96%), HAQ-DI ≤0.5 (95%), and PASI ≤1 (91%) were the individual components of MDA that consistently achieved the greatest response rates followed by swollen joint count ≤1 (87%), patient global VAS ≤20 (87%), tender joint count ≤1 (80%), and patient pain VAS ≤15 (78%) at Wk 24. A similar trend for the pooled secukinumab MDA responder group was observed at Wk 52. Among the MDA responders 40% (27/68) and 33% (30/93) met all of the seven components at Wks 24 and 52, respectively in the overall study population. Greater improvements in SF-36 MCS and PCS, PsAQoL, FACIT Fatigue, and DLQI scores were seen among MDA responders compared to non-responders at Wks 24 and 52 (Figure).

Conclusion: In pts treated with secukinumab, the individual components most frequently associated with MDA response were related to enthesitis, skin, and functional status and the arthritis-related components were also achieved by many pts. A high proportion of pts achieved and maintained their MDA response through Wk 52 and amongst those 33 to 40% were able to meet 7/7 MDA criteria. Achieving MDA with secukinumab was associated with greater patient-reported quality of life outcomes indicating MDA may be a patient-relevant outcome References: 1. Coates LC et al. Ann. Rheum. Dis. 2016;75 S2:605. 2. Strand V et al. Poster presented at XIX PANLAR Panama 2016, April 10‒14, 2016, Panama City, Panama. 3. McInnes IB, et al. Lancet 2015;386:1137–46.

Figure: PROs among MDA responders and non-responders at Wk 24 and 52

Disclosure: L. C. Coates, Abbvie, Janssen, 2,Abbvie, BMS, Celgene, Pfizer, UCB, MSD, Boehringer Ingelheim, Novartis, Lilly, Janssen, 5; P. J. Mease, Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, 1,Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, 5,Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, 8; L. Gossec, UCB, Consultant for AbbVie, BMS, Celgene, Janssen, Novartis, Pfizer and UCB, 2; B. Kirkham, Abbvie, Novartis and Roche, 2,Abbott, BMS, Chugai, MSD, Novartis, Pfizer, Roche and UCB,, 5,Abbott, BMS, Chugai, MSD, Novartis, Pfizer, Roche and UCB, 8; L. Rasouliyan, Novartis through employment at RTI Health Solutions, 5,RTI Health Solutions, 3; S. Mpofu, Novartis, 1,Novartis, 3; S. Jugl, Shareholder of Novartis Pharma AG, 1,Full-time employee of Novartis Pharma GA, Basel, Switzerland, 3; C. Karyekar, Novartis Pharmaceuticals, 1,Novartis Pharmaceuticals, 3; K. Gandhi, Novartis Pharmaceuticals, 1,Novartis Pharmaceuticals, 3.

To cite this abstract in AMA style:

Coates LC, Mease PJ, Gossec L, Kirkham B, Rasouliyan L, Mpofu S, Jugl S, Karyekar C, Gandhi K. Patients with Active Psoriatic Arthritis Achieving Minimal Disease Activity with Secukinumab Treatment Demonstrate Sustained Improvement of Function and Quality of Life [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/patients-with-active-psoriatic-arthritis-achieving-minimal-disease-activity-with-secukinumab-treatment-demonstrate-sustained-improvement-of-function-and-quality-of-life/. Accessed .

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