#United States #AbbVie #North Chicago #Upadacitinib #Non-Segmental Vitiligo

AbbVie Announces Positive Results for Upadacitinib in Non-Segmental Vitiligo Patients

AbbVie, based in North Chicago, Illinois, has recently released promising top-line results from two pivotal Phase 3 clinical trials (Study 1 and Study 2) assessing the efficacy and safety of Upadacitinib (15 mg, once daily) for the treatment of adults and adolescents suffering from Non-Segmental Vitiligo (NSV). This condition, which affects over 90% of vitiligo patients, is characterized by symmetrical patches of skin losing pigment on both sides of the body. It has significant psychosocial effects, making the outcomes of this trial particularly noteworthy for patients.

In these studies, the primary endpoints—Total Vitiligo Area Scoring Index (T-VASI 50) and Facial Vitiligo Area Scoring Index (F-VASI 75)—were successfully achieved, with reductions in the severity of affected skin areas after 48 weeks of treatment. Approximately 70% of patients entered the trials with T-VASI scores exceeding 10 and both trials demonstrated statistically significant improvements for the Upadacitinib group when compared to the placebo group.

Dr. Kori Wallace, AbbVie's Vice President and Global Head of Immunology Clinical Development, emphasized the impact of vitiligo beyond skin appearance, stating, "Vitiligo is not merely a skin condition. It can seriously affect the confidence, identity, and daily lives of patients. These Phase 3 results represent an important milestone in AbbVie's commitment to expanding solutions in the immunology space for patients in need."

The involved clinical trials measured significant aspects such as the total body area affected by vitiligo and the facial impact of this disease, which holds a substantial psychological burden for many patients. Notably, in Study 1, a greater percentage of patients taking Upadacitinib achieved T-VASI 50 and F-VASI 75 compared to those on placebo.

The safety profile of Upadacitinib observed in these trials generally aligned with that of already approved treatments, with no new safety concerns arising. Most reported adverse events were mild to moderate, including upper respiratory infections and acne. Importantly, severe adverse events were infrequent and occurred at similar rates between the Upadacitinib and placebo groups.

Historically, vitiligo has been a poorly addressed condition, with a lack of FDA-approved systemic therapies available for patients. Dr. Thierry Passeron, a professor of dermatology, noted the ongoing uncertainty and disappointment experienced by many vitiligo patients due to limited treatment options. The encouraging results from AbbVie’s trials suggest that targeting the inflammatory processes associated with vitiligo could yield visible results, providing patients with a viable treatment option moving forward.

Currently, the use of Upadacitinib for NSV has not been approved, and further evaluations are ongoing to assess its safety and efficacy. Non-Segmental Vitiligo, characterized by the loss of melanocytes, manifests in white patches across the skin and affects approximately 0.5% to 2.3% of the global population, with up to 84% of patients experiencing the NSV subtype. The daily difficulties of living with this condition often lead to mental health challenges such as anxiety and depression.

Viti-Up Clinical Trials Overview

The Viti-Up clinical program consists of two identical Phase 3 trials aimed at evaluating the safety, efficacy, and tolerability of Upadacitinib in NSV patients who are eligible for systemic therapy. Over 600 participants from 90 global sites were randomized in these studies, extending their clinical investigation of Upadacitinib over a total of 160 weeks.

Both trials assessed the core efficacy measures including T-VASI 50 and F-VASI 75 at 48 weeks, as well as secondary endpoints focused on facial pigmentation recovery—progress crucial for the mental and emotional well-being of patients living with vitiligo. The outcomes of these trials represent a significant advancement in the search for effective treatments for a condition that severely impacts the quality of life for those afflicted by it.

For more detailed information about these trials, you can visit ClinicalTrials.gov.

About Upadacitinib

Discovered and developed by AbbVie, Upadacitinib is an oral JAK inhibitor under investigation for multiple immunological conditions. It has shown promise in blocking inflammatory pathways involved in various immune-mediated diseases, and current Phase 3 studies aim to open new avenues for effective treatment solutions across a range of conditions including alopecia areata and hidradenitis suppurativa.

About AbbVie

AbbVie’s mission centers on developing innovative therapies to tackle serious health issues and improving the lives of individuals. Their focus areas include immunology, oncology, neuropsychiatry, and more. To learn more about AbbVie, visit their official website or check out their presence on social platforms.