Updated Integrated Safety Analysis of Ritlecitinib up to ~ 5 Years in Patients with Alopecia Areata from the ALLEGRO Clinical Trial Program.

What was studied

This study looked at the safety of ritlecitinib, a pill for alopecia areata. People in it were aged 12 years and up. The team pooled data from 4 trials in the ALLEGRO program. They tracked side effects for up to about 5 years. One group had 1294 people who took any dose of the drug. Within it, 1228 people took 50 mg each day. Some of them first took 200 mg daily for 4 weeks.

What they found

The typical time on the drug was 1197 or 1204 days. Side effects of any kind were common in both groups. In the 50 mg group, 1070 of 1228 people had one. Headache, a positive COVID test, and nose and throat infections led the list. Serious side effects were much less common. There were 2 deaths in total. Some people stopped the drug or study due to a side effect. Shingles came up at 1.0 per 100 years of use. Cancer, not counting some skin cancers, came up at 0.3 per 100 years. Major heart and blood vessel events came up at 0.2 per 100 years.

What it means for patients

The authors say long-term use was generally well tolerated. This held for up to about 5 years of use. They say the safety picture was in line with earlier reports. This applies to people aged 12 and up with alopecia areata.

Why it is not certain yet

This report looks at safety only, not hair growth. The data were only summed up and described, without formal tests. Data came from 4 trials with different doses. The abstract does not say what caused the 2 deaths. Rare harms can be hard to spot, even in big groups.

Source

Updated Integrated Safety Analysis of Ritlecitinib up to ~ 5 Years in Patients with Alopecia Areata from the ALLEGRO Clinical Trial Program.

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