1. Patients in the ritlecitinib group showed significant improvements in alopecia symptoms, with Severity of Alopecia Tool (SALT) scores ≤ 20, compared to placebo.
2. Adverse events between groups were comparable; there were no reported deaths.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Alopecia areata is an autoimmune form of hair loss that affects both children and adults. Intralesional corticosteroids and Janus kinase (JAK) inhibitors serve as first-line treatment options for the disease. Ritlecitinib is a dual JAK3 and tyrosine-kinase expressed in hepatocellular carcinoma (TEC) inhibitor which may be more effective than conventional therapy, although little is known to date. This randomized controlled trial aimed to evaluate the safety and efficacy of ritlecitinib among patients with alopecia areata. The primary outcome was a Severity of Alopecia Tool (SALT) score below 20 while a key secondary outcome included a moderately or greatly improved Patient Global Impression of Change (PGI-C) score. According to study results, patients assigned to ritlecitinib reported significant improvements in the primary outcome at week 24 compared to those receiving placebo with a tolerable safety profile. This study was strengthened by a stratified design that compared multiple dosing regimens during the loading and maintenance phases of the study.
Click to read the study in The Lancet
Relevant Reading: Two Phase 3 Trials of Baricitinib for Alopecia Areata
In-depth [randomized-controlled trial]: Between Dec 3, 2018, and Jun 24, 2021, 1097 patients were screened for eligibility across 118 sites in 18 countries. Included were patients ≥ 12 years with a known diagnosis of alopecia areata and ≥ 50% scalp hair loss. Patients were randomized into seven different treatment groups. Two groups received 200 mg loading doses of ritlecitinib for four weeks followed by maintenance of 50 mg (n=132) or 30 mg (n=130) daily. Three groups received 50 mg (n=130), 30 mg (n=132), or 10 mg (n=63) of ritlecitinib daily without a loading phase. Lastly, two groups received placebo for 24 weeks followed by re-allocation to ritlecitinib 50 mg daily with (n=65) or without (n=66) a four-week 200 mg loading phase. Altogether, 718 patients were enrolled in the study.
The primary outcome of a SALT score ≤ 20 was substantially greater in the ritlecitinib groups (31% in 200 mg+50 mg, 22% in 200 mg+30 mg, 23% in 50 mg, and 14% in 30 mg group) versus the placebo group (2%) at week 24. There was no difference in adverse events across either the intervention group (82% in ritlecitinib 200 mg+50 mg, 81% in 200 mg+30 mg, 85% in 50 mg, 80% in 30 mg, and 76% in 10 mg) or control group (83% in placebo to ritlecitinib 200 mg+50 mg, and 86% in placebo to ritlecitinib 50 mg group). The majority of adverse events were mild-to-moderate in nature with no deaths reported. Overall, findings from this study suggest that ritlecitinib may be both safe and effective for systemic therapy among patients with alopecia areata.
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