TY - JOUR T1 - Secukinumab in United States Biologic-Naïve Patients With Psoriatic Arthritis: Results From the Randomized, Placebo-Controlled CHOICE Study JF - The Journal of Rheumatology JO - J Rheumatol SP - 894 LP - 902 DO - 10.3899/jrheum.210912 VL - 49 IS - 8 AU - Tien Nguyen AU - Melvin Churchill AU - Robert Levin AU - Guillermo Valenzuela AU - Joseph F. Merola AU - Alexis Ogdie AU - Ana-Maria Orbai AU - Jose U. Scher AU - Arthur Kavanaugh AU - Farid Kianifard AU - Chauncy Rollins AU - Renato Calheiros AU - Olivier Chambenoit Y1 - 2022/08/01 UR - http://www.jrheum.org/content/49/8/894.abstract N2 - Objective To evaluate secukinumab (SEC) 300 mg and 150 mg vs placebo in a United States–only population of biologic-naïve patients with psoriatic arthritis (PsA).Methods CHOICE was a double-blind, randomized controlled trial conducted in the US. Biologic-naïve patients with PsA and psoriasis (PsO) were randomized 2:2:1 to SEC 300 mg (n = 103), SEC 150 mg (n = 103), or placebo (n = 52). The primary objective was to show superiority of SEC 300 mg vs placebo in American College of Rheumatology 20% (ACR20) response at week 16. Additional objectives included the effect of SEC on dactylitis, enthesitis, PsO, and safety.Results ACR20 response rates at week 16 were higher with SEC 300 mg than with placebo (51.5% vs 23.1%; odds ratio 3.51 [95% CI 1.65-7.45]; P = 0.001). SEC 300 mg also led to greater ACR50/70 responses and improvements in other variables vs placebo. Responses were generally sustained over time. Patients with inadequate response to SEC 150 mg at weeks 16, 28, or 40 who received dose escalation to 300 mg experienced improved clinical response after uptitration. The most common adverse events were upper respiratory tract infections and diarrhea. No inflammatory bowel disease was reported or new safety signals observed.Conclusion SEC 300 mg led to rapid and significant improvements over placebo in symptoms of PsA in this heavier population of US-only, biologic-naïve patients. Findings were consistent with previous studies and suggest that SEC 300 mg is a safe and efficacious first-line biologic treatment for patients with PsA. [ClinicalTrials.gov: NCT02798211] ER -