Secukinumab Versus Adalimumab for Psoriatic Arthritis: Comparative Effectiveness up to 48 Weeks Using a Matching-Adjusted Indirect Comparison.

Peter Nash,Howard Thom,Iain B Mcinnes,Kunal Gandhi,Matthias Hunger,Philip J Mease,Shephard Mpofu,Steffen M Jugl,Andreas Karabis

doi:10.1007/s40744-018-0106-6

Abstract

Secukinumab and adalimumab are approved for adults with active psoriatic arthritis (PsA). In the absence of direct randomized controlled trial (RCT) data, matching-adjusted indirect comparison can estimate the comparative effectiveness in anti-tumor necrosis factor (TNF)-naïve populations. Individual patient data from the FUTURE 2 RCT (secukinumab vs. placebo; N = 299) were adjusted to match baseline characteristics of the ADEPT RCT (adalimumab vs. placebo; N = 313). Logistic regression determined adjustment weights for age, body weight, sex, race, methotrexate use, psoriasis affecting ≥ 3% of body surface area, Psoriasis Area and Severity Index score, Health Assessment Questionnaire Disability Index score, presence of dactylitis and enthesitis, and previous anti-TNF therapy. Recalculated secukinumab outcomes were compared with adalimumab outcomes at weeks 12 (placebo-adjusted), 16, 24, and 48 (nonplacebo-adjusted). After matching, the effective sample size for FUTURE 2 was 101. Week 12 American College of Rheumatology (ACR) response rates were not significantly different between secukinumab and adalimumab. Week 16 ACR 20 and 50 response rates were higher for secukinumab 150mg than for adalimumab (P = 0.017, P = 0.033), as was ACR 50 for secukinumab 300mg (P = 0.030). Week 24 ACR 20 and 50 were higher for secukinumab 150mg than for adalimumab (P = 0.001, P = 0.019), as was ACR 20 for secukinumab 300mg (P = 0.048). Week 48 ACR 20 was higher for secukinumab 150 and 300mg than for adalimumab (P = 0.002, P = 0.027), as was ACR 50 for secukinumab 300mg (P = 0.032). In our analysis, patients with PsA receiving secukinumab were more likely to achieve higher ACR responses through 1year (weeks 16-48) than those treated with adalimumab. Although informative, these observations rely on a subgroup of patients from FUTURE 2 and thus should be considered interim until the ongoing head-to-head RCT EXCEED can validate these findings. Novartis Pharma AG.

Highlights

Secukinumab and adalimumab are approved for adults with active psoriatic arthritis (PsA)
For patients with active psoriatic arthritis (PsA), international recommendations such as those of the European League Against Rheumatism (EULAR) [1, 2] and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) [3] advise the use of biologic diseasemodifying antirheumatic drugs when a patient’s response to conventional synthetic DMARDs is inadequate
In the principal analysis of patient-reported outcomes (PROs) data, we observed significantly improved week-24 HAQDI, Patient Global Assessment (PGA), and pain assessments and week-48 Health Assessment Questionnaire Disability Index (HAQ-DI) scores for patients treated with secukinumab 150 mg, and a significantly improved PGA score for secukinumab 300 mg relative to those treated with adalimumab

Summary

Introduction

Secukinumab and adalimumab are approved for adults with active psoriatic arthritis (PsA). To help optimize treatment plans for this long-term chronic condition, appropriately powered head-to-head (H2H) randomized controlled trials (RCTs) comparing the efficacy and safety of different bDMARDs are required. One such trial is EXCEED, directly comparing the long-term (52 weeks) efficacy and safety of the fully human anti-IL-17A secukinumab with the anti-TNF adalimumab [5]. Until data from this trial become available, clinicians and health technology assessment bodies may need to resort to adjusted indirect comparisons of these medicines as the best available evidence to inform treatment decisions

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