Evidence-Based Data on How Long to Treat to Achieve Treatment Response With Baricitinib in Severe Alopecia Areata

Abstract

Introduction: Previous data on baricitinib treatment in severe alopecia areata (AA) has shown that treatment response varies by baseline disease severity and by duration of current episode.  In general, hair regrowth response varies, and clinicians lack data on how long to optimally treat patients to achieve response.   

In the literature, time to onset of improvement (defined as 30% improvement from baseline SALT score, i.e. SALT30 can predict ultimate achievement of SALT score ≤20 by Week 52. In this analysis, we evaluated improvement(SALT30) and meaningful response(SALT score ≤20), in clinically relevant subpopulations to characterize time required to treat patients based on their disease presentation.   

Procedure: Patients randomized to treatment with baricitinib 4mg daily for up to 52 weeks were evaluated from the pooled BRAVE AA1/AA2 phase 3 trials according to four clinically relevant subpopulations divided by baseline SALT score (severe: 50-94; very severe: 95-100) and current AA episode duration (<4 years; >4 years).  

Patients achieving SALT30 improvement across visits was evaluated for each subpopulation.  Among those achieving SALT30, proportion of patients achieving SALT score ≤20 through Week 52 was evaluated at the timepoint during which SALT30 improvers began to plateau. Non- Responder Imputation was used for the missing SALT30 and SALT score ≤20. 

Results: Among subpopulations with baseline severe AA, the proportion of SALT30 improvers plateaued between 24weeks (61-70%) and 36 weeks (63%-73%) of treatment. Among those who reached SALT30 improvement at Week 24, achievement of SALT score ≤20 at Week 52 was 75% vs. 65%, respectively among those with < 4 years vs. > 4 years duration of current episode.  

In the baseline very severe AA group, the proportion of SALT30 improvers continued to increase through 52 weeks without plateau. 

Discussion: This data suggests that 'how long to treat’ with baricitinib 4 mg monotherapy can be tailored to patient baseline characteristics.  Evidence of improvement (SALT30) is seen relatively early among those patients with baseline severe SALT score(50-94). Most who achieve improvement at 6 months achieve clinical response (SALT score < 20) within a year of treatment. This suggests that if improvement is seen by 6 months, treatment should be continued to achieve optimal outcomes.   

Patients with a very severe SALT score (95-100) at baseline (i.e. alopecia totalis or universalis) show continuing (SALT30) improvement up to 1 year. Very severe AA may need at least 1 year to see evidence of treatment effect before considering a stop or switch in therapy, and longer treatment may be required in some improvers to achieve optimal outcomes.