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Abstract Number: 1738

Secukinumab for the Treatment of Psoriatic Arthritis: Comparative Effectiveness Versus Adalimumab Using a Matching-Adjusted Indirect Comparison

Peter Nash1, Iain B McInnes2, Philip J Mease3, Ernest H. Choy4,5, Howard Thom6, Chrysostomos Kalyvas7, Kunal Gandhi8, Shephard Mpofu9 and Steffen Jugl9, 1Department of Medicine, University of Queensland, Brisbane, QLD, Australia, 2University of Glasgow, Glasgow, United Kingdom, 3Swedish Medical Center and University of Washington, Seattle, WA, 4Section of Rheumatology, Cardiff University School of Medicine, Cardiff, United Kingdom, 5CREATE Center, Division of Infection and Immunity,, Cardiff University, Cardiff, United Kingdom, 6University of Bristol, Bristol, United Kingdom, 7MAPI Group, Houten, Netherlands, 8Novartis Pharmaceuticals Corporation, East Hanover, NJ, 9Novartis Pharma AG, Basel, Switzerland

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Psoriatic arthritis

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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 (SEC) and adalimumab (ADA) are approved for the treatment of active PsA in adults with an inadequate response to conventional DMARDs. A head-to-head randomized controlled trial (RCT) between SEC and ADA was recently announced (EXCEED 1) but until the results are available, matching-adjusted indirect comparison (MAIC) can be used to estimate short- and long-term comparative effectiveness. MAIC adjusts for differences in baseline patient characteristics by using individual patient data (IPD) from one or more trials to match the population of another trial. The aim of this MAIC was to assess the relative effectiveness of SEC and ADA in active PsA using data from FUTURE 1, FUTURE 2 and ADEPT RCTs.

Methods: IPD from the pooled SEC 150 mg arms of FUTURE 1 (n = 202) and FUTURE 2 (n = 100) were weighted to match the published baseline characteristics of the ADA 40 mg arm of ADEPT (n = 151). SEC 300 mg was not included because it was not used in FUTURE 1. Logistic regression was used to determine weights for age, body weight, sex, race, methotrexate use, presence of psoriasis on ≥ 3% of body surface area, Psoriasis Area Severity Index score, Health Assessment Questionnaire Disability Index (HAQ-DI) score, dactylitis, enthesitis and previous anti-TNF therapy. Recalculated outcomes with SEC 150 mg from the FUTURE RCTs (estimated sample size [ESS]: 105) were compared with published aggregate ADA outcomes from ADEPT at weeks 16, 24 and 48. Placebo-adjustment was not valid because patients in ADEPT could receive rescue therapy from week 12. Comparisons are presented as response rates (%, non-placebo-adjusted) and as pairwise comparisons using odds ratios (ORs) and change in mean score from baseline for HAQ-DI.

Results: After matching, ACR 20 and 50 response rates at week 16 were higher for SEC than for ADA (OR [95% CI]: 1.57 [0.94, 2.64]; p = 0.085 and OR: 1.77 [1.06, 2.96]; p = 0.029, respectively). At week 24, there was no evidence of differences in ACR response between SEC and ADA. At week 48, there was evidence of higher ACR 20 and 50 response rates with SEC than with ADA (OR: 2.01 [1.18, 3.43]; p = 0.010 and OR: 1.58 [0.96, 2.61]; p = 0.072, respectively) and evidence of greater improvements in HAQ-DI score (SEC: −0.50 [−0.56, −0.45] vs ADA: −0.40 [−0.48, −0.32]; p = 0.0388). HAQ-DI results were not available at week 16 and there was no evidence of differences at week 24. These findings were consistent with a sensitivity analysis that also matched for PsA disease duration, swollen joint count and CRP (SEC ESS = 62).

Conclusion: This MAIC showed that SEC 150 mg was associated with higher ACR 20 and 50 response rates at weeks 16 and 48, and greater improvements in HAQ-DI scores at week 48, relative to ADA. Key limitations included not being able to placebo-adjust or include the SEC 300 mg dose and the reduced ESS for SEC. The awaited results from EXCEED 1 are needed to substantiate the findings of this analysis.

 

MAIC ACR response rates at weeks 16, 24 and 48  


Disclosure: P. Nash, Novartis Pharma AG, 2,Novartis Pharma AG, 5,Novartis Pharma AG, 8; I. B. McInnes, BMS, Pfizer, Celgene, Astra Zeneca, 2,Novartis, Janssen, Abbvie, Pfizer, UCB, BMS, MSD, 5; P. J. Mease, AbbVie, Amgen, BMS, Lily, Novartis, Pfizer, UCB, 2,AbbVie, Amgen, BMS, Lily, Novartis, Pfizer, UCB, Merck, Sun, Corrona, 5,AbbVie, Amgen, Celgene, Genetech, Novartis, Pfizer, UCB, 8; E. H. Choy, None; H. Thom, Novartis Pharma AG, F. Hoffmann-La Roche AG, 5; C. Kalyvas, Mapi Group, 3,Novartis Pharma AG, 5; K. Gandhi, Novartis Pharmaceuticals Corporation, 1,Novartis Pharmaceuticals Corporation, 3; S. Mpofu, Novartis Pharma AG, 1,Novartis Pharma AG, 3; S. Jugl, Shareholder of Novartis Pharma AG, 1,Full-time employee of Novartis Pharma AG, Basel, Switzerland, 3.

To cite this abstract in AMA style:

Nash P, McInnes IB, Mease PJ, Choy EH, Thom H, Kalyvas C, Gandhi K, Mpofu S, Jugl S. Secukinumab for the Treatment of Psoriatic Arthritis: Comparative Effectiveness Versus Adalimumab Using a Matching-Adjusted Indirect Comparison [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/secukinumab-for-the-treatment-of-psoriatic-arthritis-comparative-effectiveness-versus-adalimumab-using-a-matching-adjusted-indirect-comparison/. Accessed .
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