SEE HOW RINVOQ
PUTS UC IN CHECK.
AND KEEPS IT THERE.
Results were measured at Weeks 8 and 52.1
Achieved clinical remission* at Week 8
Achieved clinical remission* at Week 52
Recommended Maintenance Dosing:
A dose of 30 mg may be considered for patients with refractory, severe or extensive disease. Discontinue if therapeutic response is not achieved with the 30 mg dose.
OPEN-LABEL LONG-TERM EXTENSION: INTERIM ANALYSIS (AS OBSERVED)6
Clinical remission* up to ~2 years
In the LTE analysis, the data is segmented as follows:
• RINVOQ 15 mg arm: Patients who achieved clinical remission (remitters) on RINVOQ 15 mg at Week 52 of Maintenance Trial and received continuous RINVOQ 15 mg in LTE period (n=101).
• RINVOQ 30 mg arm: All patients on RINVOQ 30 mg who completed Week 52 of Maintenance Trial (remitters and non-remitters) and received continuous RINVOQ 30 mg in the LTE period (n=175)
OLE LIMITATIONS: In an OLE, there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
AO DISCLOSURE: In an as observed (AO) analysis missing visit data was excluded from calculations for that visit, which may increase the percent of responders. All observed data was used regardless of premature discontinuation of study drug, or initiation of concomitant medications. The same patient may not have a response at each timepoint.
*Clinical remission is defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1 without friability.
U-ACHIEVE INDUCTION & U-ACCOMPLISH Study Design Intro:1 8-week, double-blind, placebo-controlled Phase 3 clinical studies of 988 patients (473 patients for U-ACHIEVE and 515 patients for U-ACCOMPLISH) with moderately to severely active ulcerative colitis and demonstrated prior treatment failure to oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic treatment. Patients were randomized to receive either RINVOQ 45 mg or placebo once daily for 8 weeks. The primary endpoint was clinical remission per modified Mayo Score at Week 8.
U-ACHIEVE MAINTENANCE Study Design Intro:1 52-week, double-blind, placebo-controlled Phase 3 clinical study of 746 patients enrolled were randomized to the maintenance study. The primary efficacy analysis population was the first randomized 451 patients. Patients were randomized to receive RINVOQ 15 mg, 30 mg or placebo once daily for up to 52 weeks. The primary endpoint was clinical remission per modified Mayo Score at Week 52.
U-ACTIVATE Long Term Extension (LTE) Open-Label Study: Data presented at approximately 2 years is an interim analysis at 48 weeks of the U-ACTIVATE study, which is an ongoing 288-week, long-term study evaluating the efficacy and safety from patients who came from the U-ACHIEVE trial. Analysis includes patients from both primary (the first 451 patients to enter the maintenance study) and full maintenance populations (n=681). At the time of analysis, not all patients have reached 48 weeks of the LTE study.6