Journal of the American Academy of Dermatology · 2024
FRONTIER-2: A phase 2b, long-term extension, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Ferris Laura K, Bagel Jerry, Huang Yu-Huei, Pink Andrew E, Tyring Stephen K, Kokolakis Georgios, DeLozier Amy M, Li Shu, Shen Yaung-Kaung, Iaconangelo Charles, Ota Takayuki, Bissonnette Robert
Аннотация
BACKGROUND: More patients with moderate-to-severe plaque psoriasis achieved responses with JNJ-77242113, a targeted oral peptide inhibiting interleukin-23 receptor signaling, versus placebo (PBO) at week (W)16 of the phase 2 FRONTIER-1 study.
OBJECTIVE: FRONTIER-2, a long-term extension of FRONTIER-1, evaluated JNJ-77242113 through 1 year.
METHODS: FRONTIER-1 participants received JNJ-77242113 at doses from 25 mg daily to 100 mg twice daily or PBO through W16. Patients completing FRONTIER-1 could enroll in FRONTIER-2 and continue JNJ-77242113 at the same dose through W52. Those on PBO crossed over to JNJ-77242113 100 mg daily for W16-52. Safety follow-up continued through W56.
RESULTS: Most (89%) FRONTIER-1 patients continued to FRONTIER-2. Across outcomes, response rates were maintained from W16-52. The highest response rates generally occurred with JNJ-77242113 100 mg twice daily. At W52, 76% of patients achieved up to 75% improvement in Psoriasis Area and Severity Index (PASI75) with 100 mg twice daily; rates of clear or almost clear skin were 64% (PASI90), 74% (Investigator's Global Assessment 0/1), 40% (PASI100), and 43% (Investigator's Global Assessment 0). From W16-56, 59% of JNJ-77242113-treated patients had ≥1 adverse events. Serious adverse events, considered unrelated to treatment by investigators, occurred in 4% of patients.
LIMITATIONS: The study was limited by the small number of patients in each treatment group and the descriptive nature of the longer-term data.
CONCLUSION: Rates of skin clearance with JNJ-77242113 were durable to 1 year and no safety signals were identified.
OBJECTIVE: FRONTIER-2, a long-term extension of FRONTIER-1, evaluated JNJ-77242113 through 1 year.
METHODS: FRONTIER-1 participants received JNJ-77242113 at doses from 25 mg daily to 100 mg twice daily or PBO through W16. Patients completing FRONTIER-1 could enroll in FRONTIER-2 and continue JNJ-77242113 at the same dose through W52. Those on PBO crossed over to JNJ-77242113 100 mg daily for W16-52. Safety follow-up continued through W56.
RESULTS: Most (89%) FRONTIER-1 patients continued to FRONTIER-2. Across outcomes, response rates were maintained from W16-52. The highest response rates generally occurred with JNJ-77242113 100 mg twice daily. At W52, 76% of patients achieved up to 75% improvement in Psoriasis Area and Severity Index (PASI75) with 100 mg twice daily; rates of clear or almost clear skin were 64% (PASI90), 74% (Investigator's Global Assessment 0/1), 40% (PASI100), and 43% (Investigator's Global Assessment 0). From W16-56, 59% of JNJ-77242113-treated patients had ≥1 adverse events. Serious adverse events, considered unrelated to treatment by investigators, occurred in 4% of patients.
LIMITATIONS: The study was limited by the small number of patients in each treatment group and the descriptive nature of the longer-term data.
CONCLUSION: Rates of skin clearance with JNJ-77242113 were durable to 1 year and no safety signals were identified.