AbbVie's Rinvoq Shows Promise in Treating Severe Alopecia Areata

AbbVie announced positive results from a late-stage trial of its alopecia candidate, Rinvoq (upadacitinib). The trial met its main goal, testing 15 mg and 30 mg daily doses for treating severe alopecia areata. The study found both doses to be effective in treating the condition.

AbbVie (NYSE: ABBV) has announced positive topline results from the second of two pivotal Phase 3 clinical trials for severe alopecia areata, demonstrating significant hair regrowth in treated patients. The trial evaluated upadacitinib (RINVOQ), a drug candidate that achieved its primary endpoint, with both 15 mg and 30 mg daily doses showing effectiveness in treating the condition [1].

The study found that 45.2% of patients receiving the 15 mg dose and 55.0% of those on the 30 mg dose achieved at least 80% scalp hair coverage after 24 weeks of treatment, compared to just 1.5% of patients on placebo [2]. Additionally, 35.2% and 45.8% of patients on the 15 mg and 30 mg doses respectively reached 90% or more scalp hair coverage, versus 0.7% in the placebo group. The trial also met key secondary endpoints related to improvements in eyebrows and eyelashes [3].

AbbVie's vice president of global immunology clinical development, Kori Wallace, noted that these positive results strengthen the growing body of evidence supporting the potential of upadacitinib to improve the lives of people with AA. The company's strong financial performance, including a 71% gross profit margin, underscores its robust drug development pipeline [3].

The safety profile of upadacitinib in alopecia areata was generally consistent with that observed in approved indications. The most common treatment-emergent adverse events included upper respiratory tract infection, acne, increased blood creatine phosphokinase, and nasopharyngitis. Serious adverse events occurred in 1.9% and 1.8% of patients in the 15 mg and 30 mg groups respectively, compared to 0.7% in the placebo group. No deaths, major adverse cardiovascular events, or venous thromboembolic events were reported [3].

Upadacitinib is not currently approved for use in alopecia areata, and its safety and efficacy for this indication have not yet been evaluated by regulatory authorities. The results from this study align with the previously reported findings from the first parallel replicate study of the Phase 3 program [1].

References:
[1] https://www.marketscreener.com/news/abbvie-announces-positive-topline-results-from-second-phase-3-up-aa-trial-evaluating-upadacitinib-r-ce7c51d3d18df520
[2] https://www.nasdaq.com/press-release/abbvie-announces-positive-topline-results-second-phase-3-aa-trial-evaluating
[3] https://www.investing.com/news/company-news/abbvie-reports-positive-results-for-alopecia-areata-treatment-93CH-4204614