Session Type: ACR Abstract Session
Session Time: 9:00AM-10:30AM
Background/Purpose: Psoriatic arthritis (PsA) is characterized by peripheral synovitis, enthesitis, dactylitis and spondylitis, and IL-23 is involved in the pathogenesis of these conditions either directly or indirectly. Risankizumab (RZB), a potent humanized IgG1 monoclonal antibody and selective IL23p19 inhibitor, exhibited superior efficacy vs placebo via ACR responses and PASI scores in patients (pts) with active PsA over 24 weeks (wks). Here, the objective is to report the safety and efficacy of RZB in pts who continued into the open-label extension (OLE, NCT02986373) after completing a 24-Wk Phase 2 study.
Methods: : Pts who completed the 24-Wk double-blind Phase 2 study and met the inclusion criteria were eligible to enroll in this 52-Wk, single-arm, OLE and received 150 mg RZB every 12 wks for 36 wks. Safety and efficacy assessments (ACR and PASI responses, DAS28[CRP], Leeds Indices [dactylitis and enthesitis], and SF-36) were recorded at each visit (wks 0, 4, 12, 24, 36, 48, 52).
Results: Of 173 pts who completed the 24-Wk study, 145 (83.8%) enrolled in the OLE. The median age was 51 years and 61 (42.1%) pts were female. At baseline (BL, Week 0 of the 24-Wk study), 63 (44.4%) pts had psoriasis (PsO) ≥3% BSA, 40 (27.8%) / 73 (53.5%) showed presence of dactylitis/enthesitis, 35 (24.1%) had prior TNFi exposure and 83 (57.2%) were receiving concomitant MTX. Compared with response rates for pooled RZB data from the 24-Wk study, the ACR and PASI (in pts with PsO ≥3% BSA) response rates were higher/similar at Wk 52 (n/N: ACR20: 68/135 to 76/101; ACR50: 31/135 to 44/101; ACR70: 18/136 to 25/101; PASI90: 33/57 to 30/41; PASI100: 23/57 to 25/41; observed data). Mean change from BL (ΔBL) in DAS28[CRP] increased from -1.4 to -1.9 (Wk 52 mean: 2.7) and ΔBL in Leeds indices for dactylitis and enthesitis were -74.5 and -1.8, respectively. Pts also reported increase in ΔBL in physical and mental component summaries of SF-36 at Wk 52. There were no deaths, malignancies or cases of active tuberculosis in the study. A total of 60% pts had treatment-emergent adverse event (TEAEs), with viral upper respiratory tract infection being the most common (11.0%). Serious TEAEs and TEAEs leading to RZB discontinuation were low (3.4%).
Conclusion: Pts with active PsA treated with RZB maintained improvement in joint and skin symptoms throughout the OLE with no new or unexpected safety findings. These results were substantiated by enhanced patient quality-of-life.
To cite this abstract in AMA style:Papp K, Gooderham M, Morita A, Kivitz A, Sinvhal R, Topp A, Heap G, Eldred A, Mease P. Safety and Efficacy Results from the Open Label Extension of a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor in Patients with Active Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/safety-and-efficacy-results-from-the-open-label-extension-of-a-phase-2-trial-of-risankizumab-a-selective-il-23p19-inhibitor-in-patients-with-active-psoriatic-arthritis/. Accessed July 13, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-efficacy-results-from-the-open-label-extension-of-a-phase-2-trial-of-risankizumab-a-selective-il-23p19-inhibitor-in-patients-with-active-psoriatic-arthritis/