While the JAK inhibitor market for alopecia areata (AA) has grown increasingly crowded in recent years, Rinvoq’s clinical performance in the hair follicle-attacking autoimmune disease could earn AbbVie a prominent seat at the table.
After 24 weeks of treatment, Rinvoq (upadacitinib) at two doses—15 mg and 30 mg—helped 44.6% and 54.3% of adult alopecia patients achieve 80% or more scalp hair coverage, respectively, in a phase 3 trial. That compared to just 3.4% of patients on placebo who achieved the same level of hair growth.
Patients enrolled in the study entered at a baseline of roughly 16% scalp hair coverage, as determined by the severity of alopecia tool (SALT), AbbVie said in a July 30 press release.
Meanwhile, across the same two Rinvoq doses, 36% and 47.1% of patients achieved 90% or more scalp hair coverage versus just 1.4% of patients in the trial’s control arm, AbbVie said.
Rinvoq also met several secondary endpoints in the study by improving eyebrow and eyelash coverage and helping a certain percentage of patients on both doses achieve complete scalp hair coverage at the trial’s 24-week mark.
“Often misunderstood as a cosmetic issue, AA is a systemic immune-mediated disease that can cause total hair loss, involving the scalp, eyebrows and eyelashes,” Kori Wallace, M.D., Ph.D., AbbVie’s vice global head of immunology clinical development, said in a release. “UP-AA is the first pivotal program to have ranked and met the rigorous standard of SALT=0, indicating complete scalp hair regrowth.”
AbbVie did not indicate a regulatory plan for Rinvoq in the indication. The company is awaiting results from a parallel replicate study, which are expected later this quarter.
While cross-trial comparisons are often problematic because of differences in timing, patient populations and other variables, Rinvoq appears to provide better results than three other JAK inhibitors currently on the market in the indication.
The most recently approved treatment for alopecia, Sun Pharma’s Leqselvi, was tested on 1,220 patients in two trials with an average scalp coverage of 13%. At the 24-week mark, more than 30% of patients saw their scalp coverage increase to at least 80%.
Eli Lilly’s Olumiant was approved in 2022 for alopecia based on trials that showed between 17% and 22% of patients taking a 2 mg daily dose achieve 80% scalp coverage after 36 weeks, while 32% to 35% of patients taking a 4 mg daily dose reached the same standard. Pfizer’s Litfulo was approved in 2023 after a study showed 23% of patients reached 80% or more of scalp coverage after six months of treatment.
Last week, AbbVie reported Rinvoq’s second-quarter sales at $2.03 billion for a 42% year-over-year increase. The product generated $5.97 billion in revenue last year. The treatment hit the market in 2019 to treat patients with rheumatoid arthritis. Since then, it has been cleared in several other indications, including psoriatic arthritis, atopic dermatitis, Crohn’s disease and ulcerative colitis.
