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      INITIATION GUIDE
      PRODUCT INFORMATION
      PATIENT BOOKLET
      RINVOQ CD banner

      RINVOQ® (upadacitinib) 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.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:
      • 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.

      RINVOQ achieved the two co-primary endpoints of disease control:
      endoscopic response (per simple endoscopic score for Crohn’s disease [SES-CD]) and clinical remission (per stool frequency and abdominal pain score [SF/APS]) at Week 12 and 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.

      ONCE-DAILY RINVOQ

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      In 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 medicine1

      RINVOQ

      A  QUICK INTRODUCTION

      RINVOQ is an oral, once-daily, selective and reversible JAK1 inhibitor now registered 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.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 co-primary endpoints of disease control were endoscopic response (per simple endoscopic score for Crohn’s disease [SES-CD]) and clinical remission (per stool frequency and abdominal pain score [SF/APS]) at Week 12 and Week 52.1,2

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      SIGNIFICANT

      ENDOSCOPIC HEALING*1,2

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      *Significantly improved endoscopic remission at Week 12 for RINVOQ 45 mg (29% and 19%) vs placebo (7% and 2%) and Week 52 for RINVOQ 15 mg (19%) and RINVOQ 30 mg (29%) vs placebo (5%); secondary endpoints, p<0.001 for all.1,2

      See Week 12 and Week 52 endoscopic remission

      Endoscopic remission (SES-CD) = SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore >1 in any individual variable.1

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      RAPID RESPONSE†1,2

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      †More patients achieved clinical response (CR-100)^ at Week 2 with RINVOQ 45 mg (32% and 33%) vs placebo (20% and 12%); secondary endpoint, p<0.001.1,2

      See Week 2 clinical response

      ^Clinical response (CR-100) = Decrease of at least 100 points in CDAI from baseline.1

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      SUSTAINED CLINICAL
      REMISSION‡

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      ‡More patients maintained clinical remission (SF/APS)** at Week 52 with RINVOQ 15 mg (51%) and RINVOQ 30 mg (60%) vs placebo (20%) after achieving clinical remission at induction Week 12 with RINVOQ 45 mg; secondary endpoints, p<0.001 for all.1,2

      See Week 52 clinical remission

      **Clinical remission (SF/APS) = Average daily SF ≤ 2.8 and APS ≤1.0 and neither greater than baseline.1

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      SAFETY EXPERIENCE

      across multiple indications§1,3-7

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      §22 Phase 3 clinical trials across 7 approved indications in rheumatology, dermatology and gastroenterology.1,3–7

      See RINVOQ's safety profile in CD
      See RINVOQ's overall safety profile

      Induction studies (U-EXCEED and U-EXCEL) were replicate multicentre, double-blind, placebo-controlled clinical studies that evaluated RINVOQ 45 mg over 12 weeks. Patients receiving corticosteroids at baseline initiated a corticosteroid taper regimen starting at Week 4. Patients who achieved clinical response (per SF/APS) at Week 12 in U-EXCEED or U-EXCEL were re-randomized to receive RINVOQ 15 mg, RINVOQ 30 mg or placebo for an additional 52 weeks in the U-ENDURE maintenance study.1,2

      Study design

      REFERENCES

      1. RINVOQ Product Information.
      2. Loftus EV, et al. N Engl J Med. 2023;388:1966–80 (incl. supplementary appendix).
      3. Kameda H, et al. Rheumatology (Oxford). 2020;59(11):3303–13.
      4. Zeng X, et al. Int J Rheum Dis. 2021;24(12):1530–9.
      5. Rubbert-Roth A, et al. N Engl J Med. 2020;383(16):1511–21.
      6. Katoh N, et al. Dermatol Ther (Heidelb). 2023;13(1):221–34.
      7. Blauvelt A, et al. JAMA Dermatol. 2021;157(9):1047–55.

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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-RNQG-240034. April 2024