Researchers conclude continual use of ritlecitinib safe in alopecia areata
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Key takeaways:
- In two treatment cohorts, up to 75.4% and 84.5% of ritlecitinib-treated patients reported an adverse event.
- Serious adverse events occurred in 0 to 3.2% of patients.
Ritlecitinib was well tolerated and safe when continually used to treat alopecia areata in patients aged 12 years and older, according to a study.
There are only two therapies approved to treat severe alopecia areata (AA), one of which is ritlecitinib (Litfulo, Pfizer), an oral Janus kinase (JAK) 3 inhibitor approved in June 2023 as the first treatment for patients aged 12 years and older with severe AA. The approval was supported by data from the ALLEGRO clinical program that showed ritlecitinib was efficacious as AA treatment.
In the current study, Brett King, MD, PhD, associate professor of dermatology at Yale School of Medicine and a member of Healio’s Dermatology Peer Perspective Board, and colleagues assessed the safety and tolerability of ritlecitinib through an integrated analysis of pooled data.
“The objective of this analysis was to assess the safety profile of ritlecitinib in AA, including evaluation of known safety events of interest for immunomodulators and JAK inhibitors,” King and colleagues wrote.
The researchers analyzed the safety of ritlecitinib in two cohorts — a placebo-controlled group (n = 881) and an all-exposure group (n = 1,294) — gathered from three past studies and an ongoing, open-label, long-term study in the ALLEGRO program.
In the placebo-controlled cohort, the median exposure to ritlecitinib was 169 days. Researchers found that 70.2% to 75.4% of ritlecitinib-treated patients experienced adverse events, 0% to 3.2% of which were serious, compared with 69.5% of those taking placebo, 1.9% of which were serious. Of the 19 patients who discontinued treatment due to adverse events, five were while taking placebo.
In the all-exposure cohort, the median exposure to ritlecitinib was 624 days. Of the 84.5% of patients that reported an adverse event, 4.4% were serious. These adverse events led to 6% of patients discontinuing the trial. The most common adverse events were headache (17.7%), SARS-CoV-2 (15.5%) and nasopharyngitis (12.4%). Two deaths occurred, and both were determined to not be related to the study drug. Less than 0.1%, 1.5% and 0.5% of patients, respectively, experienced opportunistic infections, herpes zoster and malignancies (excluding nonmelanoma skin cancer), and 0.2% experienced major adverse cardiovascular events.
“Ritlecitinib is well tolerated with an acceptable safety profile up to 24 months in patients aged 12 years and older with AA,” the researchers concluded, stating that additional data from the ongoing, long-term ALLEGRO phase 3 study will provide further safety information of taking ritlecitinib for AA for up to 5 years.
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