AbbVie Shares Topline Results from Its Phase 3 Trial for Alopecia Areata

AbbVie has announced topline results for the second of its two Phase 3 clinical trials evaluating upadacitinib (RINVOQ) for alopecia areata. 

What is RINVOQ?

The treatment is a prescription Janus kinase (JAK) inhibitor that is used to treat several conditions, like rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and atopic dermatitis. It is currently also being investigated as a treatment for alopecia areata.

The Trial

The trial was a randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of upadacitinib for alopecia areata.

• The trial randomized 1,399 participants with severe alopecia areata aged 12-64 across 248 sites worldwide.
• In Period A, participants were randomized to one of three groups to receive 15 mg or 30 mg upadacitinib or a placebo for 24 weeks.
• In Period B, participants randomized to upadacitinib in Period A continue the same treatment for 28 weeks. Participants randomized to placebo in Period A either remain on the placebo or are randomized to one of the two treatment groups, based on their SALT score at week 24. 
• Participants who complete the studies may join a third study and may be re-randomized to receive either 15 or 30 mg of upadacitinib for up to 108 weeks.

Topline Results

• Both doss of upadacitinib achieved the primary endpoint, with 45.2% and 55% of patients treated with 15 or 30 mg upadacitinib, reaching 80% or more scalp hair coverage (SALT score ≤20) at week 24 compared to 1.5% of patients receiving placebo (p<0.001). 
• 35.2% and 45.8% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage (SALT ≤10) compared to 0.7% of patients receiving placebo at week 24 (p<0.001). 
• Key secondary endpoints were met, including the percentage of patients with improvements in eyebrows and eyelashes as well as the percentage of subjects with complete scalp hair coverage (SALT=0), with both doses of upadacitinib at week 24.
• Treatment-emergent serious adverse events (TEAEs) occurred in 1.9% and 1.8% of patients in the upadacitinib 15 and 30 mg groups, respectively, and 0.7% in the placebo group. 
• Discontinuations due to TEAEs occurred in 1.1% and 1.5% of patients in the treated groups, respectively, and none in the placebo group.
• The most common TEAEs were:
  • Upper respiratory tract infection
  • Acne
  • Increase in blood creatine phosphokinase
  • Nasopharyngitis

Reflections

These results are promising for those with severe alopecia areata, demonstrating robust efficacy with both 15 and 30 mg doses. The magnitude of response is striking, with more than half of patients on the higher dose achieving substantial scalp regrowth by week 24.

Some considerations do remain, however:

Durability of response: Will the encouraging results at 24 weeks be sustained or even improved with longer treatment in the extension studies?

Dose selection: While both doses were effective, the 30 mg dose produced numerically higher responses but with a slightly greater rate of discontinuations due to adverse events. Further results may show an optimal dose for treatment, while still managing adverse events.

Comparisons across JAK inhibitors: With multiple JAK inhibitors advancing in alopecia areata, including baricitinib and ritlecitinib, how will upadacitinib differentiate itself in terms of speed of regrowth, durability, and tolerability?

Ultimately, these results strengthen the role of JAK inhibition as a therapeutic backbone for alopecia areata. If confirmed with long-term follow-up, upadacitinib could offer patients a meaningful option for hair regrowth. We look forward to seeing additional data on durability, safety, and patient-reported outcomes as the program matures. 

Let us know what you think about this treatment in the comments!