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.
Mucosal healing is a STRIDE-II long-term target of UC treatment.4 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 Within STRIDE II, mucosal healing was defined by endoscopic remission (Mayo ESS 0).4
*p<0.001 vs placebo.
Brackets [*] indicate ranked secondary endpoint (multiplicity-controlled analysis, ITT, NRI-C).
NRI-C = non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
*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.
Mucosal healing at Induction Week 8 and Maintenance Week 52 were ranked secondary endpoints.1,2
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
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.
Mucosal healing at Induction Week 8 and Maintenance Week 52 were ranked secondary endpoints.1,2
Maintenance of mucosal healing at Maintenance Week 52 was a ranked secondary endpoint and was assessed in patients who achieved mucosal healing with 8-week RINVOQ 45 mg induction treatment (n=216).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
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.
ENDOSCOPIC REMISSION
at Week 8 and Week 52†1,2
*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.
†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
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.
MUCOSAL HEALING & ENDOSCOPIC REMISSION
AT WEEK 48 OF THE LTE3
Endoscopic 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
aESS ≤1.
bESS=0.
cNo imputation for missing values; patients who did not have an evaluation at Week 48 were excluded.
daMs 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.
MAINTENANCE OF ENDOSCOPIC REMISSION
AT WEEK 48 OF THE LTE3
Endoscopic remission achieved with RINVOQ 15 mg QD and 30 mg QD after the 52-week maintenance study2 was sustained through Week 48 of the LTE study in the majority of patients (no statistical analyses were conducted between doses)3
aPatients who achieved endoscopic remission (ESS=0) at Week 0 and Week 48 of the long-term extension study.
bNo imputation for missing values; patients who did not have an evaluation at Week 48 were excluded.
caMs 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.
- Turner D et al. Gastroenterology 2021;160(5):1570–83.
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AU-ABBV-220268. June 2024