RT Journal Article
SR Electronic
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
FD The Journal of Rheumatology
SP 894
OP 902
DO 10.3899/jrheum.210912
VO 49
IS 8
A1 Nguyen, Tien
A1 Churchill, Melvin
A1 Levin, Robert
A1 Valenzuela, Guillermo
A1 Merola, Joseph F.
A1 Ogdie, Alexis
A1 Orbai, Ana-Maria
A1 Scher, Jose U.
A1 Kavanaugh, Arthur
A1 Kianifard, Farid
A1 Rollins, Chauncy
A1 Calheiros, Renato
A1 Chambenoit, Olivier
YR 2022
UL http://www.jrheum.org/content/49/8/894.abstract
AB 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]