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      • RINVOQ (upadacitinib) logo
      INITIATION GUIDE
      PRODUCT INFORMATION
      PATIENT BOOKLET
      phase-3-rinvoq-v2

      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.

      Study Design
      CLINICAL REMISSION PER ADAPTED MAYO SCORE
      CLINICAL REMISSION PER ADAPTED MAYO SCORE

      RINVOQ
      ACHIEVED SIGNIFICANTLY
      HIGHER CLINICAL REMISSION
      RATES VERSUS PLACEBO AT
      INDUCTION WEEK 81,2

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      The primary endpoints of both studies were achievements of remission per adapted Mayo score at Week 8.1,2

      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.

      Study Design

      *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.

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      *p<0.001 vs placebo. Error bars show 95% CI.
      Brackets [*] indicate ranked secondary endpoint (multiplicity-controlled analysis, ITT, NRI-C).
      All other 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.

      Study Design

      REFERENCES
       

      1. RINVOQ Product Information
      2. Danese S et al. Lancet 2022;399(10341):2113–28.

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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:
      • With history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long time smokers).
      • With malignancy risk factors (e.g. current malignancy or history of malignancy).
      • Who are 65 years of age and older.

      Refer to Product Information.

      PBS Information

      RINVOQ: Authority required. Refer to PBS Schedule for full authority information.

      Please review the full Product Information (PI) before prescribing, available below.

      RINVOQ PI

      AU-ABBV-220267. June 2024