AbbVie's JAK inhibitor Rinvoq (upadacitinib) has demonstrated significant efficacy in treating alopecia areata, with new Phase III data showing the drug enabled substantial scalp hair regrowth in patients with severe hair loss. The results position Rinvoq as a potential game-changer in treating this autoimmune condition that affects millions worldwide.
Pivotal Trial Results Show Strong Efficacy
The Phase III UP-AA M23-716 clinical program tested once-daily Rinvoq at 15mg and 30mg doses in adults and adolescents with severe alopecia areata. Patients enrolled in the study had a mean baseline Severity of Alopecia Tool (SALT) score of 83.8, representing approximately 16% scalp hair coverage.
At 24 weeks, 36% of patients receiving the 15mg dose and 47.1% of those on the 30mg dose achieved 90% or more scalp hair coverage (SALT ≤ 10), compared to just 1.4% of patients receiving placebo. In a second study, 44.6% and 54.3% of patients on the respective doses reached 80% or more scalp hair coverage (SALT score ≤ 20), versus 3.4% on placebo.
"UP-AA is the first pivotal programme to have ranked and met the rigorous standard of SALT=0, indicating complete scalp hair regrowth," said Dr. Kori Wallace, AbbVie's Global Head of Immunology Clinical Development. "These data underscore AbbVie's commitment to advancing novel treatments that have the potential to improve the lives of individuals with immune-mediated diseases."
Clinical Significance and Market Impact
The results have drawn significant attention from industry analysts and clinicians. Guggenheim analysts called AbbVie's readout "impressive" and noted that the placebo-adjusted SALT scores were "much higher than what we have seen for other JAK inhibitors in the space," including Eli Lilly's Oluminant, Pfizer's Litfulo, and Sun Pharma's Leqselvi.
Dr. Arash Mostaghimi, Associate Professor of Dermatology and Vice Chair of Clinical Trials and Innovation at Harvard Medical School's Brigham & Women's Hospital, emphasized the clinical need: "There is a pressing need for more treatments that help enable regrowth of scalp and non-scalp hair. I am encouraged by these results that demonstrate the potential of upadacitinib to be an important new treatment option."
Safety Profile Remains Consistent
The safety data from the alopecia areata trials showed side effects that were "generally consistent" with Rinvoq's established profile from previous studies. Notably, there were no major adverse cardiovascular events (MACE), malignancies, or deaths reported in the study. Rinvoq's current label includes a boxed warning for serious infections, death, MACE, malignancy, and thrombosis.
Broader Treatment Benefits
Beyond scalp hair regrowth, participants in the studies also experienced improvements in eyebrows and eyelashes, with additional key secondary endpoints met at week 24 for both doses. This comprehensive hair regrowth addresses multiple aspects of alopecia areata that significantly impact patients' quality of life.
Market Positioning and Future Outlook
Guggenheim analysts highlighted Rinvoq's competitive advantages, noting it is "the dominant JAK inhibitor on the market" with "a clear advantage over competitors in terms of physician familiarity and patient access." They estimate the alopecia areata indication could contribute several hundred million to over $1 billion in annual sales for Rinvoq by the early 2030s.
AbbVie expects to report findings from Study 1 of the Phase III UP-AA clinical program in the third quarter of 2025. The company is also studying Rinvoq in Phase III trials for other indications including hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.
The strong results in alopecia areata add to Rinvoq's growing portfolio of approved indications, which currently includes Crohn's disease, ulcerative colitis, atopic dermatitis, psoriatic arthritis, and giant cell arteritis, with the most recent approval coming in April 2024.
