Positive topline results were reported today by AbbVie (NYSE: ABBV) from the first of two pivotal studies of the Phase 3 UP-AA clinical program, which assessed the safety and effectiveness of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) who had a mean baseline SALT score of 83.8 (roughly 16% scalp hair coverage).
At week 24, 44.6% and 54.3% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 80% or higher scalp hair coverage (SALT score ≤ 20), compared to 3.4% of patients receiving a placebo (p<0.001) in Study 2. Both dosages of upadacitinib met the primary endpoint.
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. People living with AA may face difficulties in managing their disease, which can significantly affect their quality of life,
UP-AA is the first pivotal program to have ranked and met the rigorous standard of SALT=0, indicating complete scalp hair regrowth. These data underscore AbbVie’s commitment to advancing novel treatments that have the potential to improve the lives of individuals with immune-mediated diseases.
Kori Wallace
Read More: AbbVie’s RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis
At week 24, 1.4% of patients receiving a placebo achieved 90% or greater scalp hair covering (SALT ≤ 10), but 36.0% and 47.1% of patients treated with upadacitinib 15 mg and 30 mg, respectively, achieved this outcome (p<0.001). 1 The percentage of participants with gains in eyelashes and eyebrows, as well as the percentage of subjects with full scalp hair coverage (SALT=0) with both dosages of upadacitinib at week 24, were additional important secondary goals that were achieved.
The sudden and often unpredictable hair loss people living with AA experience can profoundly impact their self-esteem and mental well-being,
There is a pressing need for more treatments that help enable regrowth of scalp and non-scalp hair. I am encouraged by these results that demonstrate the potential of upadacitinib to be an important new treatment option.
Arash Mostaghimi
During the 24-week, placebo-controlled phase (phase A), the safety profile of both upadacitinib dosages was mostly in line with what was seen in approved indications. Patients in the upadacitinib 15 mg and 30 mg groups experienced treatment-emergent major adverse events in 1.4% and 2.8% of cases, respectively, while the placebo group experienced none. 1In the upadacitinib 15 mg and 30 mg groups, discontinuations owing to treatment-emergent adverse events (TEAEs) happened in 0.7% and 1.4% of participants, respectively, while none happened in the placebo group. Acne, nasopharyngitis, and upper respiratory tract infections were the most frequently reported TEAEs. Only 0.7% of patients in the upadacitinib 15 mg group and 1.0% in the upadacitinib 30 mg group experienced serious infections, whereas the placebo group experienced none. No MACEs were adjudicated.
Upadacitinib
RINVOQ, a JAK inhibitor that was found and created by AbbVie researchers, is being investigated in a number of immune-mediated inflammatory disorders. RINVOQ more effectively suppressed cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 than JAK2/JAK2 in human leukocyte cellular tests. 2. It is still unknown how particular JAK enzyme inhibition relates to the safety and efficacy of treatment.
