Withdrawing baricitinib treatment for severe alopecia areata results in loss of benefit
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Key takeaways:
- By week 152, 80% of patients who were withdrawn from baricitinib therapy lost their hair again vs. only 7% of those that continued treatment.
- This finding was consistent across baricitinib doses.
After 1 year’s worth of hair regrowth among patients treated with baricitinib for severe alopecia areata, treatment withdrawal resulted in a loss of benefit for almost all patients, according to a study.
Baricitinib is an oral Janus kinase inhibitor FDA approved for the treatment of alopecia areata (AA) and must be used continuously in order to maintain treatment response.
“Clinical experience has shown that relapse is frequent on treatment discontinuation,” Brett King, MD, PhD, associate professor of dermatology at Yale University School of Medicine and a member of Healio Dermatology’s Peer Perspective Board, and colleagues wrote. “However, over the course of the disease, there may be circumstances in which clinicians and/or patients require interruption of therapy or discontinuation of therapy after response had been achieved.”
To better understand the outcomes of treatment withdrawal so that clinicians can make informed decisions on the long-term therapy plan for patients with severe AA, researchers investigated the outcomes of the phase 3 BRAVE-AA1 trial’s withdrawal period.
In the initial 52 weeks of this study, 654 patients (mean age, 37.1 years; 58.6% women) with severe AA were randomly assigned to receive either baricitinib 2 mg, baricitinib 4 mg or placebo. At week 52, 154 patients who were responders were randomly assigned to either continue their treatment or withdraw by taking placebo. Ultimately, 10 of the 39 responders taking baricitinib 2 mg and 30 of the 115 responders taking baricitinib 4 mg were randomly assigned to take placebo. These patients were once again reassigned to retreatment with their original baricitinib dose if they experienced loss of treatment benefit, defined as a SALT score worsening of more than 20 points from their week 52 results. This retreatment could take place at any visit after week 52.
Results showed that those who withdrew from treatment lost all benefits gained during active treatment. Benefits were lost gradually, with 0% of patients losing treatment benefit at week 4 and 10% to 11% losing treatment benefit by week 8 regardless of baricitinib dose.
However, by week 152, 80% of patients who were withdrawn from baricitinib therapy lost their hair again vs. only 7% of those that continued treatment. This finding was consistent across doses.
For those patients who were reassigned to placebo and experienced loss of treatment benefit, five of the eight patients and 21 of the 24 patients that began baricitinib 2 mg and baricitinib 4 mg retreatment, respectively, regained a Severity of Alopecia Tool score of 20 or less.
“In this randomized clinical trial, in patients with severe AA, withdrawal of therapy among patients who achieved meaningful hair regrowth after 1 year of treatment with baricitinib resulted in almost all patients losing their hair,” the authors confirmed. “Therefore, it is not recommended to discontinue therapy after achieving successful regrowth with 1 year of therapy.”
According to the authors, if treatment must be discontinued, but the patient begins showing signs of shedding, retreatment as soon as possible will ensure a better chance of restabilizing AA as not all patients will be able to capture their previous results.