AbbVie announces upadacitinib met primary endpoint

AbbVie announced that its Phase 2b study evaluating upadacitinib in adults with non-segmental vitiligo, or NSV, met the primary endpoint of percent change from baseline in the Facial Vitiligo Area Scoring Index, or F-VASI, at week 24 with the 11 mg and 22 mg doses versus placebo. The percent reduction from baseline in F-VASI at week 52 was numerically greater than results at week 24 for all upadacitinib doses.2 No new safety signals were identified beyond the known safety profile for upadacitinib. Based on these data, AbbVie is advancing its clinical program of upadacitinib in vitiligo to Phase 3. At week 24, upadacitinib achieved the primary endpoint of percent change from baseline in F-VASI with 11 mg and 22 mg doses versus placebo. F-VASI is a tool that measures re-pigmentation of the face and is used to assess the extent of re-pigmentation and treatment response in clinical trials.3 Higher response rates were also observed with upadacitinib versus placebo in secondary endpoints, including F-VASI 75 at week 24 with the 11 mg and 22 mg doses and Total Vitiligo Area Scoring Index 50 at Week 24 with the 22 mg dose. The mean percent reduction from baseline in F-VASI was numerically greater at week 52 than results at week 24 for all upadacitinib dose groups.2 In addition, response rates observed for F-VASI 75 and T-VASI 50 at week 52 were numerically greater than those at week 24 for all upadacitinib dose groups. No new safety signals were observed beyond the known safety profile for upadacitinib. Treatment-emergent adverse event, or TEAE, rates were generally similar with upadacitinib and placebo in period 1. Numerically higher rates of serious TEAEs and TEAEs leading to study drug discontinuation were observed in the upadacitinib 22 mg group versus the other groups. One death adjudicated as undetermined/unknown cause and deemed by the investigator to have no reasonable possibility of being related to study drug occurred in the upadacitinib 22 mg group. One adjudicated event of nonfatal ischemic stroke occurred with upadacitinib 11 mg in a patient with known cardiovascular risk factors. One event of malignancy occurred with upadacitinib 11 mg in a patient with positive family history of breast cancer. Throughout the study, a single event of serious infection was reported in the upadacitinib 22 mg group. There were no adjudicated events of venous thromboembolism, gastrointestinal perforation, or active tuberculosis. The use of upadacitinib in vitiligo is not approved and its safety and efficacy have not been evaluated by regulatory authorities. The 24-week data in this release and partial 52-week data are being presented as an oral presentation during the European Academy of Dermatology and Venerology, or EADV, Congress in Berlin, Germany, on October 12. The partial 52-week data is based on the data cutoff date of January 13. Approximately 58% of patients had an opportunity to reach 52-week at that time. The full 52-week data in this release will be presented at an upcoming medical meeting.