The European Commission (EC) has approved AbbVie’s RINVOQ (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
“Our years of experience and long-term investment in IBD research have given us invaluable insights into the challenges that ulcerative colitis patients face, and a deep understanding of the ongoing need for additional treatment options to help those still suffering,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. “We celebrate today’s approval of RINVOQ by the EC as it meaningfully expands our ability to help indicated patients in need of relief from ulcerative colitis.”
The EC approval is supported by data from two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study, U-ACHIEVE maintenance. Statistical significance was achieved for the primary endpoint and all secondary endpoints with RINVOQ 45 mg in the two induction studies and both RINVOQ 15 mg and 30 mg in the maintenance study.
During the U-ACHIEVE and U-ACCOMPLISH induction trials, 26 percent and 33 percent of patients treated with RINVOQ 45 mg achieved clinical remission at week 8, the primary endpoint, compared to 5 percent and 4 percent of patients who received placebo.
During the U-ACHIEVE maintenance trial, 42 percent and 52 percent of patients treated with RINVOQ 15 mg or 30 mg, respectively, achieved clinical remission at week 52, the primary endpoint, compared to 12 percent of patients who received placebo.
Additionally, 57 percent and 68 percent of patients receiving RINVOQ 15 mg or 30 mg, respectively, achieved corticosteroid-free remission, defined as clinical remission (per Adapted Mayo Score) and corticosteroid free for ≥90 days immediately preceding week 52 among patients who achieved clinical remission at the end of the induction treatment, compared to 22 percent of patients on placebo.
Clinical Response & Mucosal Healing
Seventy-three and 74 percent of patients treated with RINVOQ 45 mg achieved clinical response (per Adapted Mayo Score) at week 8 compared to 27 and 25 percent of patients receiving placebo during the U-ACHIEVE and U-ACCOMPLISH induction trials, respectively.
In both trials, a significantly greater proportion of patients experienced clinical response per partial Adapted Mayo Score (symptomatic response) as early as week 2 (U-ACHIEVE: 60 percent vs 27 percent and U-ACCOMPLISH: 63 percent vs 26 percent).
Mucosal healing was observed in 36 percent and 44 percent of patients treated with RINVOQ 45 mg in U-ACHIEVE and U- ACCOMPLISH, respectively, at week 8, compared to 7 percent and 8 percent of patients, respectively, who received placebo.
In the maintenance study at week 52, mucosal healing was observed in 49 percent and 62 percent of patients treated with RINVOQ 15 mg and 30 mg, respectively, compared to 14 percent who received placebo.
“Patients with ulcerative colitis live with unpredictable, often painful symptoms that significantly impact their quality of life, including emotional, social and economic impacts,” said Séverine Vermeire, M.D., Ph.D., professor of gastroenterology at University Hospital Leuven in Leuven, Belgium.
“RINVOQ demonstrated the ability to help patients experience improvements in disease parameters such as durable clinical remission and mucosal healing at week eight of induction therapy and week 52 of maintenance therapy. These results represent an exciting possibility for patients who continue to experience active disease despite treatment with conventional or biologic therapy.”