Moderate evidenceIndustry-fundedIntegrated long-term extension analysis of two Phase 3 randomized controlled trials

If a person's severe alopecia areata responds well to baricitinib within the first year, do they keep that improvement into a second year of treatment?

DraftJournal of the European Academy of Dermatology and Venereology (JEADV) · Feb 2024 · checked 17 Oct 2026

For people whose alopecia areata responds well to baricitinib in the first year, that improvement is very likely to be sustained through at least a second year of treatment, with no new safety surprises identified -- reassuring for people worried the drug might stop working or cause unexpected harm with longer-term use.

Who was studied
Subset of BRAVE-AA1/AA2 patients (originally randomized to baricitinib 2mg or 4mg) who were 'responders' (SALT score of 50 or higher, i.e. at least 50% scalp hair loss, at baseline) at week 52; exact subgroup n not confirmed from accessible sources
Type of study
Integrated long-term extension analysis of two Phase 3 randomized controlled trials
Evidence
Moderate

What they did

Followed patients from the BRAVE-AA1 and BRAVE-AA2 trials who had responded (SALT score of 20 or less) by week 52, continuing baricitinib 2 mg or 4 mg through week 104, and tracked whether they kept their hair regrowth, plus anxiety and depression scores.

What they found

Among week-52 responders, 90.7% (4 mg group) and 89.2% (2 mg group) still had a SALT score of 20 or less at week 104. Anxiety and depression scores remained improved throughout. No new safety signals were reported over the full 104-week period.

Limitations

Only reports on patients already classified as 'responders' at week 52, so it does not describe what happens to non-responders over the long term; full text could not be accessed directly (paywalled), so details rely on a secondary trade-press summary (Dermatology Times) and search-engine excerpts rather than the primary article; these BRAVE-AA trials are run and funded by the drug's manufacturer.

Who paid for it

Likely Eli Lilly and Company (manufacturer), consistent with the BRAVE-AA trial program sponsorship; not explicitly confirmed in the accessible text

Read the original

Long-term efficacy and safety of baricitinib in patients with severe alopecia areata: 104-week results from BRAVE-AA1 and BRAVE-AA2 ↗ · Senna M, Mostaghimi A, Ohyama M, et al. (full author list not confirmed from accessible sources) · DOI 10.1111/jdv.19665 · we summarised this from the abstract

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