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
HISTO-ENDOSCOPIC MUCOSAL HEALING
at Week 8 and Week 52*1,2
*Mayo endoscopic subscore (ESS) 0 or 1 without friability and Geboes score ≤3.1, secondary endpoint
*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.
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.
*Mayo endoscopic subscore (ESS) 0 and Geboes score <2, secondary endpoint
*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.
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.
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.
REFERENCES
- RINVOQ Product Information.
- Danese S et al. Lancet 2022;399(10341):2113–28.
- Panaccione R et al. UEG Journal 2023;11(8):141–
- Turner D et al. Gastroenterology 2021;160(5):1570–83.
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WARNING: Based on the results from a post-marketing safety study of another JAK inhibitor, RINVOQ should only be used if no suitable treatment alternatives are available in patients: Refer to Product Information. |
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RINVOQ: Authority required. Refer to PBS Schedule for full authority information.
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AU-ABBV-220268. June 2024