'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
Clinical Remission(+)
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.2,11,12
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.2,13
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
Clinical Response & Mucosal Healing(++)(*)
Seventy-three and 74 percent of patients treated with RINVOQ 45 mg achieved clinical response (per Adapted
In both trials, a significantly greater proportion of patients experienced clinical response per partial Adapted
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.1,2
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.1,2,13
'Patients with ulcerative colitis live with unpredictable, often painful symptoms that significantly impact their quality of life, including emotional, social and economic impacts,' said
In the placebo-controlled ulcerative colitis induction and maintenance clinical trials, the overall safety findings were generally consistent with the known safety profile of upadacitinib; no new important safety risks were observed.1 The rates of overall adverse events (AE), serious AEs, and AEs resulting in treatment discontinuation were lower with upadacitinib compared to placebo.1 The most commonly reported adverse reactions (?5 percent of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, blood CPK increased, acne, neutropaenia, and rash.1 In the overall clinical program, major cardiovascular events, thrombotic events, malignancy excluding non-melanoma skin cancer, and gastrointestinal perforation were reported infrequently (all
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