RINVOQ (upadacitinib) is indicated for the treatment of adult patients with moderate to severe active ulcerative colitits, who have had an inadequate response, loss of response or intolerance to either conventional or biological medicine.1
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. |
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.
RINVOQ:
A QUICK INTRODUCTION
RINVOQ is an oral, once-daily, selective and reversible JAK1 inhibitor now registered for the treatment of adult patients with moderate to severe active ulcerative colitis, who have had an inadequate response, loss of response or intolerance to conventional or biological medicine.1
RINVOQ should be taken at about the same time each 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. The primary endpoint was clinical remission per adapted Mayo score at induction Week 8 and maintenance Week 52.1, 2
EARLY* RESPONSE1,2
*Rapid achievement of clinical response (partial adapted Mayo score)‡ as early as Week 2 for RINVOQ 45 mg (60% and 63%) vs placebo (27% and 26%); secondary endpoint, p<0.0001.2
‡Clinical response per partial adapted Mayo score: defined as a decrease in partial adapted Mayo score ≥1 point and a ≥30% from baseline, with a decrease in rectal bleeding score ≥1 from baseline or an absolute rectal bleeding score ≤1.1,2
SUSTAINED† REMISSION1,2
RINVOQ achieved the primary endpoints of clinical remission per adapted Mayo score at induction Week 8 and maintenance Week 52, in those who achieved a clinical response at induction week 8.1,2
†Maintenance of clinical remission (adapted Mayo score)‡ at Week 52 for RINVOQ 15 mg (59%, N=47) and RINVOQ 30 mg (70%, N=58) vs placebo (22%, N=54) in those who achieved clinical remission at the end of Week 8 with RINVOQ 45 mg (26%, N=319; and 33%, N=341); secondary endpoint, p<0.001 for all at Week 52.1
‡All endpoint definitions as per the RINVOQ Product Information.
Clinical remission: defined as adapted Mayo score ≤2 with Stool Frequency Subscore [SFS] ≤1 and not greater than baseline, RBS=0, endoscopic subscore [ESS] 0 or 1 without friability.
Corticosteroid-free clinical remission: defined as 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 among patients who achieved clinical remission at the end of the induction treatment.
MUCOSAL HEALING
ON§ AND BELOW¶ THE SURFACE1
MUCOSAL HEALING MEASURES AT INDUCTION WEEK 8 AND MAINTENANCE WEEK 52
ENDOSCOPIC REMISSION = ESS 0
MUCOSAL HEALING = ESS 0 or 1 without friability
HISTOLOGIC-ENDOSCOPIC MUCOSAL HEALING = ESS 0 or 1 without friability and Geboes ≤3.1
§Significantly improved mucosal healing (ESS 0 or 1 without friability)‡ at Week 8 for RINVOQ 45 mg (36% and 44%) vs placebo (7% and 8%) and Week 52 for RINVOQ 15 mg (49%) and RINVOQ 30 mg (62%) vs placebo (14%);secondary endpoints, p<0.001 for all.1
¶Significantly improved deep mucosal healing (ESS 0, Geboes score <2)‡ at Week 8 for RINVOQ 45 mg (11% and 13%) vs placebo (1% and 2%) and Week 52 for RINVOQ 15 mg (18%) and RINVOQ 30 mg (19%) vs placebo (5%); secondary endpoints, p<0.001 for all.1
Geboes score: a measure of histologic inflammation, where a score of ≤3.1 indicates neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue.
‡All endpoint definitions as per the RINVOQ Product Information.
SAFETY EXPERIENCE
across multiple indications1,3-5
19 Phase 3 clinical trials across 6 approved indications in rheumatology, dermatology and gastroenterology.1,3-5
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.
Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderate to severe active ulcerative colitis, who have had inadequate response, loss of response or intolerance to conventional or biological medicine.
Crohn's Disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease, who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological medicine.
Atopic dermatitis
RINVOQ is indicated for use in adults and adolescents aged 12 years and above who weigh at least 40 kg, for the treatment of moderate to severe atopic dermatitis which is inadequately controlled with active topical pharmacotherapies and for whom systemic therapy is indicated.
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).
RINVOQ may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
Ankylosing spondylitis
RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis.
Psoriatic arthritis
RINVOQ is indicated for the treatment of moderate to severe active psoriatic arthritis in adult patients who have responded inadequately to or are intolerant to one or more DMARDs.
RINVOQ may be used as monotherapy or in combination with a non-biological DMARD.
Non-radiographic
Axial Spondyloarthritis
RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) change, who have responded inadequately to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
AD: atopic dermatitis; AS: ankylosing spondylitis; ESS: endoscopic subscore; NRI-C: non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19; PsA: psoriatic arthritis; QD: once-daily; RA: rheumatoid arthritis; RBS: rectal bleeding score;
REFERENCES
- RINVOQ Product Information.
- Danese S et al. Lancet 2022;399(10341):2113–28.
- Kameda H et al. Rheumatology (Oxford) 2020;59(11):3303–13.
- Zeng X et al. Int J Rheum Dis 2021;24(12):1530–9.
- Rubbert-Roth A et al. N Engl J Med 2020;383(16):1511–21.
- 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. |
PBS Information
RINVOQ: Authority required. Refer to PBS Schedule for full authority information.
Please review the full Product Information (PI) before prescribing, available below.
AU-ABBV-220266. August 2023