Hair Loss
A Phase 3 trial reveals that upadacitinib, an arthritis drug, significantly aids hair regrowth in severe alopecia areata patients Towfiqu Barbhuiya/Pexels

An arthritis drug has shown significant hair-regrowth potential in people with severe alopecia areata, with a large Phase 3 trial finding that more than half of patients taking the higher dose regained at least 80% of their scalp hair within six months.

The drug, upadacitinib, is an oral Janus kinase (JAK) inhibitor already used to treat inflammatory conditions. New findings from two Phase 3 clinical trials, published in JAMA Dermatology on 12 August, suggest it could also offer a potential treatment option for adults and adolescents with severe alopecia areata.

The international trials involved 1,399 patients aged 12 to 64 with severe alopecia areata, an autoimmune condition in which the immune system attacks hair follicles and can cause extensive hair loss.

More Than Half Regained Most Scalp Hair

Participants were randomly assigned to receive either 15mg or 30mg of upadacitinib once daily, or a placebo.

After 24 weeks, 45.2% and 44.6% of patients receiving the 15mg dose in the two trials achieved at least 80% scalp hair coverage. The results were even stronger among those taking 30mg, with 55% in one trial and 54.3% in the other reaching the same threshold.

By comparison, only 1.5% and 3.4% of patients receiving placebo achieved at least 80% scalp hair coverage.

The results also included patients who achieved complete regrowth of scalp hair. In one trial, 20.3% of patients receiving 30mg reached a SALT score of zero, meaning no measurable scalp hair loss, compared with none in the placebo group.

Drug Works by Targeting Immune Response

Alopecia areata is an immune-mediated disease rather than a form of conventional hair loss. The immune system mistakenly attacks hair follicles, disrupting normal hair growth.

Upadacitinib works by selectively inhibiting JAK1, a pathway involved in immune and inflammatory signalling. By suppressing this activity, the treatment may reduce the immune attack on hair follicles and allow hair growth to resume.

The researchers found that responses could emerge relatively quickly, with the primary hair-coverage outcome becoming significantly different from placebo as early as eight weeks in the trials.

The treatment also produced improvements in eyebrow and eyelash hair, as well as measures of quality of life associated with the condition.

Results Offer Hope but Drug Is Not a Cure

The findings are significant because severe alopecia areata can cause extensive and sometimes near-total hair loss, with substantial psychological and social consequences.

However, the results do not mean that upadacitinib will restore hair for everyone with alopecia areata.

The trials showed that around half of patients receiving the higher dose achieved the 80% scalp-coverage threshold after 24 weeks, meaning a substantial proportion did not reach that level of regrowth during the study period. Complete regrowth was also achieved by a smaller percentage of participants.

The researchers reported no new safety findings, with the most commonly reported adverse events including upper respiratory tract infections, acne, elevated creatine phosphokinase, and nasopharyngitis. Serious adverse events occurred more frequently in the 30mg group than the 15mg group.

Upadacitinib is not simply a new hair-loss treatment yet. The findings show that an existing immune-targeting medicine could potentially become another option for people with severe alopecia areata, a condition where additional effective treatments are still needed.