FDA approves Rinvoq for ulcerative colitis.- AbbVie

This FDA approval is the first indication for Rinvoq in gastroenterology and is supported by efficacy and safety data from three Phase III randomized, double-blind, placebo-controlled clinical studies. The two induction studies (U-ACHIEVE and U-ACCOMPLISH) utilized Rinvoq 45 mg once daily for 8 weeks, and then 15 mg or 30 mg once daily for the maintenance study (U-ACHIEVE maintenance) through 52 weeks.

Across all clinical trials, significantly more patients treated with Rinvoq achieved clinical remission at weeks 8 and 52, the primary endpoint based on the mMS: stool frequency subscore (SFS) less or equal to 1 and not greater than Baseline, rectal bleeding subscore (RBS) = 0, endoscopy subscore (ES) of less or equal to 1 without friability, compared to placebo. In addition, the studies met all ranked secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), as well as corticosteroid-free clinical remission in the maintenance study. All primary and ranked secondary endpoints achieved p-values of <0.001 versus placebo.></0.001>

During the U-ACHIEVE and U-ACCOMPLISH induction trials at week 8, 26 percent and 33 percent of patients treated with Rinvoq 45 mg achieved clinical remission, the primary endpoint based on mMS, compared to 5 percent and 4 percent of patients who received placebo. Onset of response occurred as early as Week 2, with a greater proportion of patients receiving Rinvoq 45 mg once daily achieving clinical response, defined as a decrease of at least 1 point and at least 30 percent from Baseline and a decrease in RBS of at least 1 or an absolute RBS less or equal to 1 per the pmMS, compared to placebo. During the 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 mMS) and corticosteroid free for at least 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.