A Phase 3 trial program involving 3 studies, U-ACHIEVE Induction (N=473) and U-ACCOMPLISH (N=515), and 1 maintenance study, U-ACHIEVE Maintenance (N=451). The clinical trials evaluated RINVOQ 45mg vs placebo for induction, and RINVOQ 15mg and 30mg vs placebo for maintenance treatment.*1,2 Patients in clinical remission (aMs 5–9 with centrally assessed endoscopic subscore of 2–3) at Week 0 of the LTE study/Week 52 of maintenance entered the U-ACTIVATE long-term extension study (LTE).3
*Patients who achieved clinical response per adapted Mayo score with 8-week RINVOQ 45 mg QD induction treatment entered maintenance.
RINVOQ
ACHIEVEMENT OF CLINICAL REMISSION AT MAINTENANCE WEEK 52*1,2
*Patients achieving clinical remission per adapted Mayo score at maintenance week 52 in those achieved clinical response at induction week 8, primary endpoint1
Induction studies U-ACHIEVE (UC-1) and U-ACCOMPLISH (UC-2) were replicate multicentre, double-blind, placebo-controlled clinical studies. Week 8 responders per aMs from both UC-1 and UC-2 were pooled and entered the U-ACHIEVE maintenance study (UC-3) and were re-randomised 1:1:1 to receive RINVOQ 15mg, RINVOQ 30mg or placebo for up to 52 weeks.
*p<0.001 vs placebo.
Brackets [*] indicate primary endpoint (multiplicity-controlled analysis, ITT, NRI-C).
NRI-C = non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
RINVOQ
ACHIEVED MAINTENANCE OF CLINICAL REMISSION AT MAINTENANCE WEEK 52*1,2
*Proportion of patients who achieved clinical remission per adapted Mayo score at induction week 8† and maintained clinical remission until maintenance week 52, secondary endpoint.1,2
†Following 8 weeks of induction 26% and 33% of patients in U-ACHIEVE (N=319) and U-ACCOMPLISH (N=341) treated with RINVOQ 45 mg QD achieved clinical remission per adapted Mayo score, primary endpoint.1,2
Induction studies U-ACHIEVE (UC-1) and U-ACCOMPLISH (UC-2) were replicate multicentre, double-blind, placebo-controlled clinical studies. Week 8 responders per aMs from both UC-1 and UC-2 were pooled and entered the U-ACHIEVE maintenance study (UC-3) and were re-randomised 1:1:1 to receive RINVOQ 15mg, RINVOQ 30mg or placebo for up to 52 weeks.
*p<0.001 vs placebo.
Brackets [*] indicate primary endpoint (multiplicity-controlled analysis, ITT, NRI-C).
NRI-C = non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
RINVOQ
CLINICAL REMISSION RATES PER PARTIAL
MAYO SCORE UP TO WEEK 52*1,2
*Following 8 weeks of induction treatment with RINVOQ 45 mg in patients who achieved a clinical response per aMS, additional pre-specified endpoint
Clinical remission per partial Mayo score up to Week 521,2
Partial May score ≤2 (consisting of SPS, RBS and PGA all ≤1)
Bars represent 95% CI (ITT).2
All comparisons are non-ranked and not controlled for multiplicity.
NRI-C = non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
Induction studies U-ACHIEVE (UC-1) and U-ACCOMPLISH (UC-2) were replicate multicentre, double-blind, placebo-controlled clinical studies. Week 8 responders per aMs from both UC-1 and UC-2 were pooled and entered the U-ACHIEVE maintenance study (UC-3) and were re-randomised 1:1:1 to receive RINVOQ 15mg, RINVOQ 30mg or placebo for up to 52 weeks.
CLINICAL REMISSION WITHOUT STEROIDS1,2 AT WEEK 52*†
*Per adapted Mayo score, secondary endpoint
†CORTICOSTEROID FREE CLINICAL REMISSION:1,2
Patients with clinical remission at induction Week 8 and maintenance Week 52.
AND
Corticosteroid-free for at least 90 days prior to maintenance Week 52 (n=159).1
Induction studies U-ACHIEVE (UC-1) and U-ACCOMPLISH (UC-2) were replicate multicentre, double-blind, placebo-controlled clinical studies. Week 8 responders per aMs from both UC-1 and UC-2 were pooled and entered the U-ACHIEVE maintenance study (UC-3) and were re-randomised 1:1:1 to receive RINVOQ 15mg, RINVOQ 30mg or placebo for up to 52 weeks.
*p<0.001 vs placebo.
Brackets [*] indicate primary endpoint (multiplicity-controlled analysis, ITT, NRI-C).
NRI-C = non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
RINVOQ ACHIEVEMENT OF CLINICAL REMISSION
AT WEEK 48 OF THE LTE3
Clinical response and remission endpoints achieved with RINVOQ 15 mg QD and 30 mg QD after the 52-week maintenance study2 were sustained through Week 48 of the LTE study (no statistical analyses were conducted between doses)3
aAdapted Mayo score ≤2, with stool frequency subscore ≤1 and not greater than baseline, RBS=0, and ESS ≤1.
bPartial Mayo score ≤2, with no subscore >1.
cDecrease in Adapted Mayo score ≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1.
dNo imputation for missing values; patients who did not have an evaluation at Week 48 were excluded.
eaMs 5–9 with centrally assessed endoscopic subscore of 2–3 at Week 0 of the LTE study/Week 52 of maintenance.
Patients who completed the U-ACHIEVE maintenance study analysed entered the LTE study if they were in clinical remission (adapted Mayo Score [aMs] 5–9 with centrally assessed endoscopic subscore of 2–3) at Week 0 of the LTE study/Week 52 of maintenance and continued the same dose of RINVOQ. Patients not in remission at Week 52 of maintenance (U-ACHIEVE) underwent dose escalation and were not analysed. Patients who underwent dose escalation or de-escalation at Week 48 of the LTE study were also excluded from this LTE analysis.
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; LTE, long-term extension; 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.
REFERENCES
- RINVOQ Product Information
- Danese S et al. Lancet 2022;399(10341):2113–28.
- Panaccione R et al. UEG Journal 2023;11(8):141–2.
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AU-ABBV-220267. June 2024