What Happens When Baricitinib Responders Stop Rx?

TOPLINE:

Among patients with severe alopecia areata (AA) who have significant hair growth with baricitinib, continuing treatment is needed to maintain hair regrowth, according to the results of a randomized study.

METHODOLOGY:

• Researchers conducted a treatment withdrawal substudy of a randomized, placebo-controlled, phase 3 clinical trial, BRAVE-AA1, at 70 centers in three countries, which included 654 adults with severe AA (Severity of Alopecia Tool [SALT] score ≥ 50), randomly assigned 3:2:2 to receive baricitinib 4 mg (n = 281), baricitinib 2 mg (n = 184), or placebo (n = 189) for 52 weeks.
• At week 52, 115 patients who had responded to baricitinib 4 mg (SALT score ≤ 20) and 39 who had responded to 2 mg re-randomized to continue baricitinib or transition to placebo.
• Responders who transitioned to placebo experienced a worsening of more than 20 points in the SALT score and were retreated with the original baricitinib dose.
• The main outcome measures were the proportion of patients who lost treatment benefit (worsening of SALT score by ≥ 20 points) through week 152 and those who experience hair regrowth after resuming treatment.

TAKEAWAY:

• At week 152, 90% of patients who continued baricitinib 4 mg beyond week 52 and 89% of those on 2 mg maintained a SALT score of ≤ 20.
• Patients who were withdrawn from baricitinib after week 52 experienced a significant decline in response, with only 20% of patients in the 4 mg group and 10% in the 2 mg group maintaining a SALT score of ≤ 20 at week 152.
• For those who continued baricitinib, only 7% experienced a loss of treatment benefit by week 152, while 80% of patients who were switched to placebo reported loss of treatment benefit by week 152.
• Among patients who experienced a loss of treatment benefit after withdrawal and were retreated with baricitinib, 87.5% of those on the 4 mg dose and 63% of those on the 2 mg dose were able to achieve a SALT score of 20 or less over time.

IN PRACTICE:

“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. Therefore, it is not recommended to discontinue therapy after achieving successful regrowth with one year of therapy,” the authors wrote.

SOURCE:

The study was led by Brett King, MD, PhD, Department of Dermatology, Yale University, New Haven, Connecticut. It was published online on August 14, 2024, in JAMA Dermatology.

LIMITATIONS:

Patient visits were less frequent toward the end of the study, potentially delaying retreatment, which might have prolonged the time needed to recapture a response in some patients. Some patients experienced a gradual response to retreatment and might not have had sufficient time to regain their response. There was also a small but clinically important risk that some patients may not respond to retreatment at all. Furthermore, quality-of-life data was not reported.

DISCLOSURES: 

This study was funded by Eli Lilly and Company. King and his spouse reported financial ties with various pharmaceutical companies, including Eli Lilly. Four authors were employees or shareholders of or received salary from Eli Lilly. Other authors also reported financial relationships with pharmaceutical companies outside this work, including Eli Lilly.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.