NORTH CHICAGO, Ill – AbbVie (ABBV) has reached a significant advancement in the development of upadacitinib (RINVOQ), a JAK inhibitor for autoimmune hair loss diseases, by announcing encouraging topline results from the second pivotal Phase 3 study assessing this medication for the treatment of severe alopecia areata.
Trial Achieves Primary Endpoints with Strong Efficacy Results
In contrast to just 1.5% of placebo patients, 45.2% of patients treated with upadacitinib 15 mg and 55.0% treated with 30 mg achieved 80% or more scalp hair coverage after 24 weeks, demonstrating the UP-AA Study 1’s exceptional efficacy (p<0.001). The Severity of Alopecia Tool (SALT) score < 20 was used to measure these results. Patients with severe alopecia areata who had a mean baseline SALT score of 84.0, or roughly 16% scalp hair covering, showed a clinically significant improvement.
Important secondary goals were also accomplished by the study; compared to 0.7% of patients who received a placebo, 35.2% and 45.8% of patients in the 15 mg and 30 mg groups, respectively, achieved 90% or more scalp hair coverage (SALT ≤ 10). Improvements in eyelash and eyebrow regrowth, as well as full scalp hair coverage (SALT = 0) for both upadacitinib dosages, were additional secondary objectives.
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Consistent Safety Profile Observed
No new safety signals were found, and the safety profile stayed mostly in line with previously authorized indications. Compared to 0.7% in the placebo group, 1.9% and 1.8% of the 15 mg and 30 mg groups experienced treatment-emergent severe side events. Adverse event-related discontinuations were rare, impacting 1.1% and 1.5% of patients in the upadacitinib groups, respectively, whereas the placebo arm experienced no discontinuations.
Acne, nasopharyngitis, elevated blood creatine phosphokinase, and upper respiratory tract infections were the most frequently reported adverse effects. There was only one instance of serious infection in the 30 mg and placebo groups, and none in the 15 mg group. Interestingly, no venous thromboembolic events, severe cardiovascular events, or deaths were adjudicated during the research.
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Comprehensive Trial Design and Next Steps
One of the most thorough assessments of alopecia areata treatment to date is the UP-AA clinical program. Two replication pivotal studies with independent randomization, investigation locations, data collection, and analysis are part of the M23-716 protocol. In 248 locations across the globe, 1,399 individuals with severe alopecia areata, ages 12 to 64, were randomly assigned to the trials.
Participants who complete the initial studies are eligible for an extended trial that lasts up to 108 weeks. The study design involves various treatment sessions that span 52 weeks. Researchers can assess the long-term safety and maintenance of hair regeneration as well as the short-term effectiveness thanks to this thorough technique.
Regulatory Pathway and Future Availability
These findings from Study 1 provide strong support for regulatory filings since they align with previously reported topline results from Study 2 of the Phase 3 UP-AA clinical program. For AbbVie, “submitting these data to regulatory bodies, bringing us one step closer to delivering upadacitinib to those living with this complex immune-mediated disease” is something that Dr. Wallace expressed excitement about.
Regulatory bodies have not yet assessed the safety and effectiveness of upadacitinib for alopecia areata, and its use in this condition is currently unapproved. Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, atopic dermatitis, and giant cell arteritis are among the autoimmune diseases for which the medication is currently licensed.
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About RINVOQ and JAK Inhibition
Scientists at AbbVie discovered and created the JAK inhibitor RINVOQ (upadacitinib). The medication showed preferential suppression of cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 as opposed to JAK2/JAK2 mediated pathways in human leukocyte cellular tests. Upadacitinib is being investigated in Phase 3 clinical studies for conditions other than alopecia areata, including vitiligo, systemic lupus erythematosus, hidradenitis suppurativa, and Takayasu arteritis.
Both Phase 3 studies’ encouraging findings could be a breakthrough for people with severe alopecia areata, a disorder that can have a major negative influence on psychological health and quality of life. Upadacitinib may soon provide a new treatment option for this difficult autoimmune illness, since regulatory applications are planned.
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Graduated from the University of Kerala'20 with B.Sc. Botany & Biotechnology. Post-graduation in Biotechnology from the University of Kerala'22. Internship experience in Cancer Research.
