Secukinumab is superior to ustekinumab in clearing skin of patients with moderate-to-severe plaque psoriasis: CLARITY, a randomized, controlled, Phase IIIb trial
Presenters: Bagel J1, Nia J2, Hashim P2, Patekar M3, de Vera A3, Hugot S3, Sheng K4, Xia S5, Muscianisi E4, Blauvelt A6, Lebwohl M2
Affiliations: 1Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ; 2Icahn School of Medicine at Mount Sinai, New York, NY; 3Novartis Pharma AG, Basel, Switzerland; 4Novartis Pharmaceuticals Corporation, East Hanover, NJ; 5Novartis Beijing Novartis Pharma Co. Ltd, Shanghai, China; 6Oregon Medical Research Center, Portland, OR
Background/Objective: Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has previously demonstrated superior efficacy to ustekinumab in the Phase IIIb CLEAR study of moderate-to-severe plaque psoriasis. Here, we report 16-week results from CLARITY, the second head-to-head trial comparing secukinumab with ustekinumab.
Methods: In this ongoing multicenter, head-to-head, double-blind, parallel-group, Phase IIIb study (NCT02826603), patients were randomized 1:1 to receive subcutaneous secukinumab 300mg or ustekinumab per label. The co-primary objectives were to demonstrate the superiority of secukinumab over ustekinumab at Week 12 in relation to the proportion of patients with 1) 90-percent or more improvement from baseline Psoriasis Area and Severity Index (PASI 90) and 2) a score of 0/1 (clear/almost clear) on the Investigator’s Global Assessment (IGA mod 2011 0/1). Key secondary objectives included demonstrating the superiority of secukinumab over ustekinumab with respect to PASI 75 at Week 4; PASI 75 and 100 at Week 12; PASI 75, 90, 100; and IGA mod 2011 0/1 at Week 16. Missing values were handled by multiple imputation.
Results: At Week 12, both co-primary objectives were met, secukinumab 300 mg (n=550) was significantly superior to ustekinumab (n=552) for the proportion of patients achieving both PASI 90 (66.5% vs. 47.9%; P<0.0001) and IGA mod 2011 0/1 (72.3% vs 55.4%; P<0.0001) response rates. Additionally, all key secondary objectives were met. At Week 4, PASI 75 response rates were significantly superior with secukinumab 300mg compared to ustekinumab (40.2% vs 16.3%; P<0.0001). At Week 16, secukinumab 300mg demonstrated significantly superior response rates compared to ustekinumab for PASI 75 (91.7% vs. 79.8%; P<0.0001), PASI 90 (76.6% vs. 54.2%; P<0.0001), PASI 100 (45.3% vs. 26.7%; P<0.0001), and IGA mod 2011 0/1 (78.6% vs. 59.1%; P<0.0001). Furthermore, at Week 12, patients receiving secukinumab 300mg compared to ustekinumab had significantly greater PASI 75 (88.0% vs. 74.2%; P<0.0001) and PASI 100 (38.1% vs. 20.1%; P<0.0001) responses. Safety findings were consistent with the known safety profile of secukinumab.
Conclusion: Secukinumab demonstrated superior results with greater improvements compared to ustekinumab across all study outcomes at Weeks 4, 12, and 16 in patients with moderate-to-severe plaque psoriasis.
Funding: This research was sponsored by Novartis Pharma AG, Basel, Switzerland.