AbbVie (NYSE: ABBV) has announced encouraging news for people living with vitiligo. The pharmaceutical company shared positive results from two large-scale clinical trials for its drug, upadacitinib, known by the brand name RINVOQ®. These Phase 3 studies suggest the treatment could be a significant step forward in managing non-segmental vitiligo (NSV), the most common form of the skin condition.
Vitiligo is more than just a cosmetic issue; it’s a chronic autoimmune disease that causes the skin to lose its pigment, creating white patches. It can have a profound impact on a person’s mental well-being and self-confidence. Currently, there are no approved systemic medical therapies designed to help restore skin pigment across the body. The latest findings from AbbVie’s research could change that, offering a potential new option for patients.
A Breakthrough in Vitiligo Treatment
The two replicate Phase 3 studies, named Viti-Up, aimed to see how effective and safe a daily 15 mg dose of upadacitinib is for adults and adolescents with NSV. The results were measured over 48 weeks, with a focus on two key goals: repigmentation of the skin on the body and, specifically, on the face.
Researchers used two primary measures to track progress:
T-VASI 50: Achieving at least a 50% improvement in the Total Vitiligo Area Scoring Index, which measures repigmentation across the entire body.
F-VASI 75: Achieving at least a 75% improvement in the Facial Vitiligo Area Scoring Index, which focuses on the face, an area often highly impactful for patients.
In both studies, upadacitinib successfully met these co-primary endpoints when compared to a placebo. This means that a significantly higher number of patients taking the drug saw substantial repigmentation than those who did not.
“Vitiligo is more than a skin condition – it’s a chronic autoimmune disease that can deeply affect a person’s confidence, identity and daily life,” said Dr. Kori Wallace, vice president and global head of immunology clinical development at AbbVie. “These Phase 3 results represent a significant milestone in AbbVie’s commitment to supporting patients.”
Understanding the Study Results
The data from the trials provides a clearer picture of the drug’s potential. In the first study, about 19% of patients on upadacitinib achieved at least a 50% improvement in their total body skin pigment (T-VASI 50), compared to just 6% of those on placebo. Similar results were seen in the second study, with 21.5% of the treatment group reaching this milestone.
The results for facial repigmentation were even more pronounced. Over 25% of patients taking upadacitinib in the first study saw at least a 75% improvement in their facial vitiligo (F-VASI 75), a figure that stands in sharp contrast to the 6% in the placebo group. The second study showed similar success.
Additionally, the studies looked at a secondary goal: achieving at least 50% facial repigmentation (F-VASI 50). Here, the difference was substantial. In one study, 48% of patients on upadacitinib reached this mark, compared to only about 13% of patients on placebo.
Dr. Thierry Passeron, a leading dermatologist and professor at Université Côte d’Azur, highlighted the importance of these findings. “For many people living with vitiligo, the journey is marked by uncertainty, frustration and a lack of medicines that can treat the disease systemically,” he noted. “These positive results indicate that targeting the underlying inflammation may offer a systemic treatment option which could help patients achieve visible results.”
Safety and What Comes Next
While efficacy is crucial, safety is just as important. The safety profile of upadacitinib in these vitiligo studies was consistent with what has been observed in its other approved uses, such as for rheumatoid arthritis and atopic dermatitis. No new safety concerns were identified. The most common side effects reported were upper respiratory tract infections, acne, and nasopharyngitis (the common cold).
Serious adverse events were rare and occurred at similar rates in both the upadacitinib and placebo groups. Importantly, there were no major cardiovascular events like heart attacks or strokes reported in patients taking the drug during the studies.
It is important to remember that the use of upadacitinib for vitiligo is still investigational. The safety and effectiveness for this specific condition have not yet been approved by regulatory authorities like the FDA. These positive Phase 3 results are a critical step in the journey toward potential approval.
AbbVie’s work on upadacitinib is part of its broader mission to develop innovative treatments for immune-mediated diseases. With these encouraging results, there is new hope for the millions of people worldwide affected by vitiligo, who may soon have a new tool to manage their condition and reclaim their confidence.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. AbbVie strives to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in their Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com.
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