Upadacitinib continues to show efficacy in severe alopecia

Key takeaways:

• Upadacitinib is an oral JAK inhibitor under investigation for multiple dermatologic indications.
• The drug demonstrated efficacy and safety for people with severe alopecia, consistent with earlier findings.

Upadacitinib continued to demonstrate safety and efficacy for severe alopecia areata in adults and adolescents, according to topline data from a second study in the phase 3 UP-AA clinical program.

“People living with alopecia areata often face considerable uncertainty related to both the severity and duration of hair loss, despite current treatment options,” Arash Mostaghimi, MD, MPA, MPH, associate professor of dermatology and vice chair of clinical trials and innovation, Brigham & Women’s Hospital, Harvard Medical School, said in a press release. “These encouraging results are consistent with and reinforce the outcomes observed in the first pivotal trial. Together, these findings underscore the potential of upadacitinib to provide meaningful hair regrowth, offering hope for those enduring the psychosocial burden associated with this disease.”

Upadacitinib (Rinvoq, AbbVie) is an oral JAK inhibitor that is being investigated in multiple indications in addition to alopecia areata (AA), including hidradenitis suppurativa, systemic lupus erythematosus and vitiligo. The phase 3 UP-AA program is composed of two parallel studies that are evaluating upadacitinib for AA. Across both trials, 1,399 participants with severe AA aged 12 to 64 years were randomly assigned upadacitinib 15 mg, 30 mg or placebo for 24 weeks. The recently released data show the 24-week results from the second replicate study.

According to the release, 45.2% and 55% of participants treated with upadacitinib 15 mg and 30 mg, respectively, achieved a Severity of Alopecia Tool score of 20 or less — meaning these participants reached 80% or more scalp hair coverage. In contrast, 1.5% of those receiving placebo achieved the same outcome.

Additionally, 35.2% and 45.8% of participants in the upadacitinib 15 mg and 30 mg groups, respectively, achieved 90% or more scalp hair coverage by week 24 vs. 0.7% in the placebo group. Some participants in both groups also exhibited eyebrow and eyelash regrowth, as well as complete scalp hair coverage by week 24.

Results showed that upadacitinib’s safety profile was generally consistent with what has been seen in studies that supported the drug’s approved indications, as well as previous results from this clinical program. A total of 1.9% and 1.8% of participants in the upadacitinib 15 mg and 30 mg groups, respectively, experienced treatment-emergent serious adverse events vs. 0.7% in the placebo group.

Discontinuations due to adverse events occurred in 1.1% and 1.5% of the respective treatment groups. The most common treatment-emergent adverse events were acne, nasopharyngitis, an increase in blood creatine phosphokinase and upper respiratory tract infection.