Ritlecitinib could be a suitable treatment option for alopecia areata patients aged 12 years and older following positive results from a recent trial.
According to results from a phase 2b/3 trial (NCT03732807) published in The Lancet, ritlecitinib (Pfizer) demonstrated efficacy in treating alopecia areata in patients aged 12 years and older with at least 50% scalp hair loss.
Ritlecitinib is an oral, selective dual Janus kinase (JAK) 3/TEC family kinase inhibitor. Safety and efficacy were investigated in a randomized, multi-country, double-blind trail that featured 18 countries and 118 trial sites.
Patients were randomly assigned to once-daily ritlecitinib or placebo for 24 weeks with or without a 4-week loading dose consisting of 50 mg, 30 mg, 200 mg followed by a 50 mg or 200 mg loading dose followed by 30 mg. A second 24-week extension period followed. During this period, ritlecitinib patients continued assigned doses and placebo patients switched to ritlecitinib 50 mg or 200 mg loading dose followed by 50 mg. Investigators, patients, and the sponsor were masked to treatment. To maintain masking, all patients received the same number of tablets.
The primary endpoint of the trial, assessed in all patients regardless of treatment option, was a Severity of Alopecia Tool (SALT) score of 20 or less at 24 weeks. Of the 1097 patients screened between December 3, 2018, and June 24, 2021, 718 were randomly assigned to receive ritlecitinib 200 mg + 50 mg (n = 132), 200 mg + 30 mg (n = 130), 50 mg (n = 130), 30 mg (n = 132), 10 mg (n = 63), placebo to 50 mg (n = 66), or placebo to 200 mg + 50 mg (n = 65). Of the 718 patients, 446 (62%) were female and 272 (38%) were male. Of those randomly assigned, 104 patients discontinued treatment. Thirty-four withdrew, 19 had adverse events (AEs), 12 were physician decided, 12 were discontinued due to lack of efficacy, 13 were lost to follow up, 5 were moved to long-term study transfer, 4 due to pregnancies, 2 for protocol deviations, 1 declined follow-up due to COVID-19, 1 attended the last visit late due to COVID-19, and 1 was non-compliant.
At 24 weeks, 38 of 124 patients (31%) in the ritlecitinib 200 mg + 50 mg group, 27 of 121 patients (22%) in the 200 mg + 30 mg group, 29 of 124 patients (23%) in the 50 mg group, 17 of 119 patients (14%) in the 30 mg group, and 2 of 130 patients (2%) in the placebo group had a response based on SALT score 20 or less, the primary endpoint.
Between the placebo and the ritlecitinib 200 mg + 50 mg group, the difference in response rate based on a SALT score of 20 or less was 29.1% (95% CI 21.2–37.9 [P < 0.0001]). The difference in response rate based on a SALT score of 20 or less between placebo and ritlecitinib was 20.8% (13.7–29.2 [P < 0.0001]) for the 200 mg + 30 mg group, 21.9% (14.7–30.2 [P < 0.0001]) for the 50 mg group, and 12.8% (6.7–20.4 [P = 0.0002]) for the 30 mg group.
AEs were reported in 108 of 131 patients (82%) in the ritlecitinib200 mg + 50 mg group, 105 of 129 patients (81%) in the 200 mg + 30 mg group, 110 of 130 patients (85%) in the 50 mg group, 106 of 132 patients in the 30 mg group, and 47 of 62 patients (76%) in the 10 mg group. In the expansion period, AEs were observed in 54 of 65 patients (83%) in the placebo to ritlecitinib 200 mg + 50 mg group, and 57 of 66 patients (86%) in the placebo to 50 mg group. Each AE incidence was similar between groups. There were no deaths.
According to the trial, authors concluded ritlecitinib was effective, well tolerated, and could be a potential treatment option for alopecia areata patients aged 12 years and older that are candidates for systemic therapy.
King B, Zhang X, Harcha WG, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. The Lancet. 2023;0(0). doi:10.1016/S0140-6736(23)00222-2