These results are consistent with the topline results from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program
AbbVie announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 84.0.
In Study 1, both doses of upadacitinib achieved the primary endpoint, with 45.2% and 55.0% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reaching 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 1.5% of patients receiving placebo (p<0.001). These results are consistent with the topline results previously announced from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program.
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“These positive results strengthen the growing body of evidence supporting the potential of upadacitinib to improve the lives of people with AA,” said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. “We are very encouraged by the improvements in both scalp and non-scalp hair regrowth observed with both doses of upadacitinib and look forward to submitting these data to regulatory bodies, bringing us one step closer to delivering upadacitinib to those living with this complex immune-mediated disease.”
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). Additional key secondary endpoints that were met included percentage of subjects 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.
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“People living with AA often face considerable uncertainty related to both the severity and duration of hair loss, despite current treatment options,” said Arash Mostaghimi, M.D., M.P.A., M.P.H., associate professor of dermatology and vice chair of clinical trials and innovation, Brigham & Women’s Hospital, Harvard Medical School. “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.”
The safety profile of both doses of upadacitinib in the 24-week, placebo-controlled period (Period A) was generally consistent with that observed in approved indications. Treatment-emergent serious adverse events occurred in 1.9% and 1.8% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and 0.7% in the placebo group. Discontinuations due to treatment-emergent adverse events (TEAEs) occurred in 1.1% and 1.5% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group. The most common TEAEs observed were upper respiratory tract infection, acne, blood creatine phosphokinase increased and nasopharyngitis. Serious infections were reported infrequently with one in the placebo group and one in the upadacitinib 30 mg group, and none in the upadacitinib 15 mg group group. There were no adjudicated MACE, adjudicated venous thromboembolic events or deaths reported. One malignancy (breast cancer) was reported in the upadacitinib 15 mg group.
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Source- PR Newswire
