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A phase 2a randomized, placebo-controlled study to evaluate the efficacy and safety of the oral Janus kinase inhibitors ritlecitinib and brepocitinib in alopecia areata: 24-week results

2021; Elsevier BV; Volume: 85; Issue: 2 Linguagem: Inglês

10.1016/j.jaad.2021.03.050

1097-6787

Brett King, Emma Guttman‐Yassky, Elena Peeva, Anindita Banerjee, Rodney Sinclair, Ana B. Pavel, Linda Zhu, Lori Ann Cox, Brittany G. Craiglow, Linda Chen, Christopher Banfield, Karen Page, Weidong Zhang, Michael S. Vincent,

Dupuytren's Contracture and Treatments

BackgroundAlopecia areata (AA) is an autoimmune form of hair loss with limited treatments.ObjectiveTo evaluate the efficacy and safety of the Janus kinase inhibitors ritlecitinib and brepocitinib in patients who have AA with ≥ 50% scalp hair loss.MethodsPatients were randomized to once-daily ritlecitinib, brepocitinib, or placebo. The primary efficacy endpoint was a 24-week change from baseline in the Severity of Alopecia Tool (SALT) score. The key secondary efficacy endpoint was the proportion of patients achieving 30% improvement in SALT score (SALT30).ResultsThe ritlecitinib, brepocitinib, and placebo groups included 48, 47, and 47 patients, respectively. At week 24, least-squares mean difference from placebo in SALT score change from baseline was 31.1 (95% confidence interval [CI], 18.8-43.5) for ritlecitinib and 49.2 (95% CI, 36.6-61.7) for brepocitinib (P < .0001 for both comparisons with placebo). SALT30 was achieved by 50% (90% CI, 38%-62%) of patients receiving ritlecitinib, 64% (90% CI, 51%-75%) receiving brepocitinib, and 2% (90% CI, 0%-9%) receiving placebo. Two patients experienced a serious adverse event (rhabdomyolysis) in the brepocitinib group only.LimitationsOnly a single-dosage regimen of each study drug was included.ConclusionTreatment with ritlecitinib or brepocitinib for 24 weeks was efficacious and generally well tolerated. Alopecia areata (AA) is an autoimmune form of hair loss with limited treatments. To evaluate the efficacy and safety of the Janus kinase inhibitors ritlecitinib and brepocitinib in patients who have AA with ≥ 50% scalp hair loss. Patients were randomized to once-daily ritlecitinib, brepocitinib, or placebo. The primary efficacy endpoint was a 24-week change from baseline in the Severity of Alopecia Tool (SALT) score. The key secondary efficacy endpoint was the proportion of patients achieving 30% improvement in SALT score (SALT30). The ritlecitinib, brepocitinib, and placebo groups included 48, 47, and 47 patients, respectively. At week 24, least-squares mean difference from placebo in SALT score change from baseline was 31.1 (95% confidence interval [CI], 18.8-43.5) for ritlecitinib and 49.2 (95% CI, 36.6-61.7) for brepocitinib (P < .0001 for both comparisons with placebo). SALT30 was achieved by 50% (90% CI, 38%-62%) of patients receiving ritlecitinib, 64% (90% CI, 51%-75%) receiving brepocitinib, and 2% (90% CI, 0%-9%) receiving placebo. Two patients experienced a serious adverse event (rhabdomyolysis) in the brepocitinib group only. Only a single-dosage regimen of each study drug was included. Treatment with ritlecitinib or brepocitinib for 24 weeks was efficacious and generally well tolerated.