Session Type: ACR Late-breaking Abstract Session
Session Time: 4:30PM-6:00PM
Background/Purpose: Interleukin-23(IL-23), a key regulator of multiple effector cytokines (including IL-17,IL-22, and TNF), has been implicated in psoriatic lesions, synovitis, enthesitis,and bone erosion. Risankizumab (RZB) is a potent humanized IgG1 mAb thatinhibits IL-23 by specifically binding its p19 subunit. The purpose of thisPhase 2 study was to investigate the safety and efficacy of RZB in patients(pts) with active psoriatic arthritis (PsA).
Methods: Ptswith active PsA were randomized in a 2:2:2:1:2 ratio to receive RZB (150 mg atweeks [Wks] 0, 4, 8, 12, and 16 [Arm 1], 150 mg at Wks 0, 4, and 16 [Arm 2],150 mg at Wks 0 and 12 [Arm 3], 75 mg single dose at Wk 0 [Arm 4]) or matching placebo(PBO, Arm 5) in this ongoing double-blind, parallel-design, dose-ranging Phase2 study. Pts were stratified at randomization by prior TNFi use and concurrentMTX use. The primary efficacy endpoint was ACR20 response at Wk 16. Additional efficacyendpoints included ACR50/70, minimal disease activity (MDA), DAS28(CRP), dactylitiscount, SPARCC enthesitis index, pain on visual analog scale (VAS), and HAQ-DI;PASI responses were assessed only in pts with psoriasis (PsO) affecting ≥3%body surface area (BSA) at baseline (BL).
Results: Amongthe 185 pts who were randomized and received the study drug, 172 (93.0%)completed 16 wks of treatment. BL demographics and disease characteristics weresimilar across treatment arms. The median age was 51 years; 80 (43.2%) pts werefemale and 89 (49.4%) pts had PsO ≥3% BSA. At BL, dactylitis orenthesitis was present in 56 (30.4%) and 119 (64.7%) pts, respectively; 45(24.3%) pts had prior TNFi exposure and 106 (57.3%) pts were receiving concomitantMTX. At Wk 16, ACR20 responses were significantly greater in pts receiving RZB (acrossall arms, 57.1–65.0%) compared with PBO (37.5%, Table 1). PASI75/90/100responses at Wk 16 were significantly higher in RZB-treated pts compared withPBO. ACR50 responses were numerically higher and improvements in HAQ-DI andenthesitis from BL were numerically greater in RZB arms. At Wk 16, RZB-treated ptsachieved significantly higher ACR70 and MDA responses as well as greaterimprovements in DAS28(CRP) and Pain–VAS.Treatment-emergent adverse events (TEAEs) were comparable across treatment arms(Table 2); the most common TEAE was infection. There were no deaths orcases of tuberculosis in RZB-treated pts; 1 adjudicated major adverse cardiovascularevent was reported in RZB arm.
Conclusion: Inthis Phase 2 study, RZB significantly improved joint and skin symptoms in ptswith active PsA. RZB was well-tolerated with no new or unexpected safetyfindings.
To cite this abstract in AMA style:Mease PJ, Kellner H, Morita A, Kivitz AJ, Papp KA, Aslanyan S, Berner B, Chen K, Eldred A, Behrens F. Efficacy and Safety Results from a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor, in Patients with Active Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-results-from-a-phase-2-trial-of-risankizumab-a-selective-il-23p19-inhibitor-in-patients-with-active-psoriatic-arthritis/. Accessed November 18, 2017.
« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - http://acrabstracts.org/abstract/efficacy-and-safety-results-from-a-phase-2-trial-of-risankizumab-a-selective-il-23p19-inhibitor-in-patients-with-active-psoriatic-arthritis/