Characterizing Loss of Response Occurring in a Small Number of Patients During 3 Years of Long-Term Maintenance Therapy with Baricitinib 4-mg: Results From BRAVE-AA1 and -AA2 Trials

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Maryanne Senna
Susan Taylor
Bianca M. Piraccini
Jerry Shapiro
Najwa Somani
Jakub P. Jedynak
Samuel Ogwu
Andrew Buchanan
Brittany Craiglow
Manabu Ohyama

Keywords

Bariticinib, Alopecia areata, maintenance, loss of response

Abstract

Introduction: Baricitinib, a approved for adults with severe alopecia areata (AA), demonstrated a high level of sustained efficacy (89.1%) at Week 152 among patients who achieved a Severity of Alopecia Tool (SALT) score ≤20 at Week 52 following one year of treatment with once-daily baricitinib 4 mg in phase 3 trials (BRAVE-AA1, BRAVE-AA2). In this post hoc analysis, we characterize patterns of loss of response during maintenance treatment (Weeks 52–152) among the 10.9% (n=14) of patients who demonstrated loss of response (SALT score >20) at Week 152 and explore differences between patients who lost vs maintained response.


Methods: Patient records were reviewed to identify patients who demonstrated loss of response at Week 152. Descriptive statistics were used to summarize baseline characteristics and the timing and extent of loss for these patients.


Results: Baseline disease characteristics differed between those losing (10.9%, n=14/129) and those maintaining (89.1%, n=115/129) treatment response. Characteristics that were numerically more common among those losing vs maintaining response were a longer baseline duration of current episode (≥4 years; 50.0% vs 20.9%, respectively) and baseline very severe AA (SALT score 95–100; 64.3% vs 35.7%, respectively). Seven patients who lost response had received a COVID-19 vaccination and/or experienced a COVID-19 infection during the maintenance period; four of these patients had a vaccination or infection ≤6 months before their initial loss of response. Overall, time to loss of response varied: six lost response within the first 4 weeks of maintenance treatment (Weeks 52–56); eight lost response at or after Week 88. The magnitude of change in SALT score also varied: 35.7% (n=5) maintained a SALT score ≤30 throughout Weeks 52–152; 21.4% (n=3) worsened to a SALT score >90 at ≥1 maintenance period visit. The median SALT score at Week 152 among patients demonstrating loss of response was 32.5.


Conclusions: A small number of patients demonstrated loss of response at Week 152 during the maintenance phase of the BRAVE trials. A third of those who lost response maintained at least 70% scalp coverage throughout the two-year maintenance period, which followed one year of initial treatment. Future research is needed to confirm what factors potentially trigger loss of response on baricitinib monotherapy and to determine the potential role of adjunctive therapies in mitigating this risk.

References

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