Can ritlecitinib deliver long-term efficacy in alopecia areata?

The efficacy of ritlecitinib as a therapy for patients with alopecia areata (AA) continued to increase over 2 years of follow-up of the ALLEGRO trials. Importantly, the agent was well tolerated in the long term. The long-term trial is ongoing and further results are expected in the future.

Prof. Melissa Piliang (Cleveland Clinic, OH, USA) presented the efficacy results from a pooled analysis of the pivotal phase 2b/3 ALLEGRO trial (NCT03732807) and the ALLEGRO-LT trial (NCT04006457) [1]. In total, 502 participants with AA received a 200 mg loading dose of ritlecitinib for 4 weeks followed by a daily dose of 50 mg, and 191 participants received 50 mg daily, without the loading dose.

After 24 months of therapy, 58.4% of the participants in the loading-dose arm and 61.6% of the non-loading-dose arm achieved a Severity of Alopecia Tool (SALT) score ≤20 (see Figure). Prof. Piliang clarified that the initial advantage in response rate of the 200 mg loading-dose group was no longer present at 24 months of follow-up. “At 12 months, we observed response rates of 52.2% in the 200/50 mg arm and 45.1% in the 50 mg arm. These rates continued to increase in the following year and turned out to be similar at 24 months.” Furthermore, a SALT score ≤10 was reached by 47.2% and 51.2% of the participants in the 200/50 mg arm and 50 mg arm, respectively.

Figure: The proportion of patients with SALT score ≤20 and ≤10 up to month 24 [1]

CI, confidence interval; SALT, Severity of Alopecia Tool.

The most common adverse events were headache (15.2–15.5%), SARS-CoV-2-positivity (12.2–14.7%), nasopharyngitis (11.0–11.2%), and acne (10.4–11.5%). Herpes simplex was seen in 2% of the participants and herpes zoster was reported in 1.2–3.7% of the participants.

“These results demonstrate the clinically meaningful and sustained long-term efficacy of ritlecitinib in patients with AA,” concluded Prof. Piliang.

1. Piliang M, et al. Long-term efficacy of ritlecitinib up to month 24: integrated analysis of the ALLEGRO phase 2b/3 and long-term phase 3 clinical studies in alopecia areata (AA). Late-breaker Session 3, WCD 2023, 3–8 July, Singapore, Singapore.