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.
*p<0.001 vs placebo, multiplicity-controlled analysis (ITT)
Clinical remission per adapted Mayo score at Week 52 was the primary endpoint.1,2
Study design: 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 and efficacy vs for both doses vs placebo was assessed at 52 weeks.1,2
*p<0.001 vs placebo, multiplicity-controlled analysis (ITT)
Maintenance of clinical remission per adapted Mayo score at Week 52 was a ranked secondary endpoint and was assessed as Clinical Remission per adapted Mayo score at Week 52 among patients who achieved clinical remission per adapted Mayo score at week 8 of RINVOQ 45 mg induction treatment (n=159).2
Study design: U-ACHIEVE SS3 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 and efficacy vs for both doses vs placebo was assessed at 52 weeks.1,2
Additional pre-specified endpoint, not controlled for multiplicity.
*Clinical remission per partial adapted Mayo score (Symptomatic remission), was defined by partial adapted Mayo score ≤2 with no subscore >1. Error bars show 95% CI.
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 an adequate response, loss of response, or intolerance to prior conventional and /or biologic treatment.1,2 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 and efficacy for both doses vs placebo was assessed at 52 weeks.1,2
Corticosteroid-free clinical remission:1,2
CLINICAL REMISSION per adapted Mayo score at the end of 8-week RINVOQ 45 mg induction treatment (n=159) and at Week 52 of maintenance treatment & corticosteroid-free ≥90 days immediately preceding Week 52.
Corticosteroid-free remission at Week 52 was a ranked secondary endpoint and was assessed in patients who achieved clinical remission per adapted Mayo score with 8-week RINVOQ 45 mg QD induction treatment.1,2 Clinical remission per adapted Mayo score: stool frequency score ≤1 and not greater than baseline, rectal bleeding score of 0 and endoscopic subscore of 0 or 1 without friability.1,2
*p<0.001 vs placebo, multiplicity-controlled analysis (ITT)
Study design: 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 and efficacy vs for both doses vs placebo was assessed at 52 weeks.1,2
*Includes non-treatment emergent deaths. †The rates of the four most frequent adverse events are listed for all studies. ‡Search criteria were based on Company MedDRA Query. §These events were determined on the basis of external adjudication. IIMACE is defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. ¶VTE is defined as deep vein thrombosis ad pulmonary embolism (fatal and non-fatal).
There were no AESIs of active tuberculosis or lymphoma in the study.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.
Watch Professor Edouard Louis discuss results from a Phase 3 clinical trial program that evaluated RINVOQ as an induction and maintenance therapy for adults with moderately to severely active UC.1,2
RINVOQ is an oral, once daily, selective and reversible JAK inhibitor now approved 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.1
RINVOQ can be taken at any time of the day, with or without food.1
A Phase 3 clinical trial program involving 3 studies: 2 replicate induction studies and 1 maintenance study evaluated RINVOQ 45 mg vs placebo for induction, and RINVOQ 15 mg and 30 mg vs placebo for maintenance treatment.
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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.
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ALL-RNQG-220224 Date of preparation: February 2024
Adverse events should also be reported to AbbVie on GBPV@abbvie.com