RINVOQ® (upadacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1
RINVOQ achieved the primary endpoints of clinical remission per adapted Mayo score at Induction Week 8 and Maintenance Week 521,2
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
A Phase 3 trial program involving 3 studies: 2 replicate induction studies (U-ACHIEVE Induction and U-ACCOMPLISH) and 1 maintenance study (U-ACHIEVE Maintenance). A total of 988 patients with moderately to severely active UC evaluating RINVOQ 45 mg QD vs placebo for induction and RINVOQ 15 mg QD and 30 mg QD vs placebo for maintenance treatment (N=451).1*
*Patients who achieved clinical response per adapted Mayo score with 8-week RINVOQ 45 mg QD induction treatment entered maintenance.
Mucosal healing is a STRIDE-II long-term target of UC treatment.3 In a Phase 3 clinical trial program evaluating the efficacy and safety of RINVOQ in UC, 4 different endpoints were used to measure mucosal healing: mucosal healing, endoscopic remission, histologic-endoscopic mucosal healing and deep mucosal healing.1,2
Histologic-endoscopic mucosal healing defined as a Mayo endoscopic subscore of 0 or 1 without friability and a Geboes score of ≤3.1.
Histologic-endoscopic mucosal healing at Induction Week 8 and Maintenance Week 52 were ranked secondary endpoints.1,2
†Patients who achieved clinical response (also known as symptomatic response) per adapted Mayo score (decrease ≥2 points and ≥30% from baseline and a decrease in RBS ≥1 from baseline or an absolute RBS ≤1) with 8-week RINVOQ 45 mg QD induction treatment were rerandomized 1:1:1 to receive either RINVOQ 15 mg QD, 30 mg QD or placebo.1,2
Study design: U-ACHIEVE Induction (UC-1) and U-ACCOMPLISH (UC-2) were replicate induction studies, both of which were multicenter, double-blind, placebo-controlled clinical studies. In UC-1 and UC-2, 988 patients (473 and 515 patients, respectively) were randomized to RINVOQ 45 mg QD or placebo for 8 weeks with a 2:1 treatment allocation ratio and included in the efficacy analysis. All enrolled patients had moderately to severely active UC defined as aMs of 5 to 9 with an ESS of 2 or 3 and demonstrated prior treatment failure including inadequate response, loss of response, or intolerance to prior conventional and/or biologic treatment. U-ACHIEVE Maintenance (UC-3) was a multicenter, double-blind, placebo-controlled clinical study with 451 patients who achieved clinical response per aMs (decrease ≥2 points and ≥30% from Baseline and a decrease in RBS ≥1 from Baseline or an absolute RBS ≤1) with 8-week RINVOQ 45 mg QD induction treatment. Patients were rerandomized 1:1:1 to receive either RINVOQ 15 mg QD, 30 mg QD or placebo.1,2
Deep mucosal healing at Induction Week 8 and Maintenance Week 52 were ranked secondary endpoints.1,2
Deep mucosal healing defined as a Mayo endoscopic subscore of 0 and Geboes score of <2.
†Patients who achieved clinical response per adapted Mayo score (decrease ≥2 points and ≥30% from baseline and a decrease in RBS ≥1 from baseline or an absolute RBS ≤1) with 8-week RINVOQ 45 mg QD induction treatment were rerandomized 1:1:1 to receive either RINVOQ 15 mg QD, 30 mg QD or placebo.1,2
Study design: U-ACHIEVE Induction (UC-1) and U-ACCOMPLISH (UC-2) were replicate induction studies, both of which were multicenter, double-blind, placebo-controlled clinical studies. In UC-1 and UC-2, 988 patients (473 and 515 patients, respectively) were randomized to RINVOQ 45 mg QD or placebo for 8 weeks with a 2:1 treatment allocation ratio and included in the efficacy analysis. All enrolled patients had moderately to severely active UC defined as aMs of 5 to 9 with an ESS of 2 or 3 and demonstrated prior treatment failure including inadequate response, loss of response, or intolerance to prior conventional and/or biologic treatment. U-ACHIEVE Maintenance (UC-3) was a multicenter, double-blind, placebo-controlled clinical study with 451 patients who achieved clinical response per aMs (decrease ≥2 points and ≥30% from Baseline and a decrease in RBS ≥1 from Baseline or an absolute RBS ≤1) with 8-week RINVOQ 45 mg QD induction treatment. Patients were rerandomized 1:1:1 to receive either RINVOQ 15 mg QD, 30 mg QD or placebo.1,2
AE: adverse event; AESI: adverse event of special interest; aMs: adapted Mayo score; CI: confidence interval; CPK: creatine phosphokinase; ESS: endoscopic subscore; GI: gastrointestinal; ITT: intention to treat; MACE: major adverse cardiac event; NMSC: non-melanoma skin cancer; NRI-C: non-responder imputation incorporating multiple imputations to handle missing data due to coronavirus disease 2019 (COVID-19); paMs: partial adapted Mayo score; QD: once-daily; RBS: rectal bleeding score; TEAE: treatment-emergent adverse event; UC: ulcerative colitis; URTI: upper respiratory tract infection; VTE: venous thromboembolism.
Learn from experts in gastroenterology on how you can help deliver mucosal healing for patients with UC, and how RINVOQ performed on mucosal healing as a secondary endpoint during a Phase 3 clinical trial program.
Doctor Walter Reinisch discusses the histologic endoscopic healing rates gathered from RINVOQ's moderately to severely active UC Phase 3 clinical trial program.
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REFERENCES
- RINVOQ Summary of Product Characteristics [DRAFT].
- Danese S, Vermeire S, Zhou W, et al. Lancet. Published online May 26, 2022. doi: https://doi.org/10.1016/S0140-6736(22)00581-5.
- Turner D, Ricciuto A, et al. Gasteroenterology. 2021;160:1570-1583.
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ALL-RNQG-220224 Date of preparation: February 2024
Adverse events should also be reported to AbbVie on GBPV@abbvie.com