Rinvoq (upadacitinib) now indicated for moderate/severely active Crohn’s disease

Health Canada has approved AbbVie’s Rinvoq (upadacitinib extended-release tablets) for the treatment of adults with moderately to severely active Crohn's disease. The approval follows the drug’s July 2023 approval for use in moderately to severely active ulcerative colitis in adults.1,2 For both inflammatory bowel disease indications, the drug is intended for patients who have demonstrated prior treatment failure—an inadequate response, loss of response or intolerance to at least one conventional and/or biologic therapy (e.g., a tumour necrosis factor [TNF] inhibitor, such as adalimumab or infliximab).1 Upadacitinib is dosed in two phases (induction and maintenance) for adults with moderately to severely active Crohn’s disease or ulcerative colitis, as summarized in the chart below.1 Indication Age range Dosage Ulcerative colitis Induction therapy Adults ≥ 18 years of age 45 mg once daily for 8 weeks Maintenance therapy Adults 18–64 years of age 15 mg or 30 mg once dailya Adults ≥ 65 years of age 15 mg once daily Crohn’s disease Induction therapy Adults ≥ 18 years of age 45 mg once daily for 12 weeks Maintenance therapy Adults 18–64 years of age 15 mg or 30 mg once dailya Adults ≥ 65 years of age 15 mg once daily The 30 mg dose should be used only in patients with severe disease or those who do not achieve an adequate response with the 15 mg dose. Consider the benefit-risk before use. In patients who respond to induction or maintenance treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.1 Rinvoq was originally supplied as a 15 mg extended-release tablet only. In September 2023, AbbVie introduced a new 45 mg extended-release tablet to facilitate dosing during the induction phase for ulcerative colitis and Crohn’s disease.3 Approval of upadacitinib for use in Crohn’s disease is supported by data from three Phase 3 clinical trials, including two induction studies (U-EXCEED & U-EXCEL) and one maintenance study (U-ENDURE). Patients included in the induction studies for Crohn’s disease had demonstrated an inadequate response or intolerance to at least one conventional and/or biologic therapy. In all three studies, significantly more patients treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response, with clinical remission measured by the Crohn's Disease Activity Index (CDAI) or by the patient-reported symptoms of stool frequency/abdominal pain score (SF/APS).2,4 In a press release announcing the new indication for Crohn’s disease, Dr. Remo Panaccione, MD, Professor of Medicine and Director of the IBD unit, University of Calgary commented that "This approval is a significant milestone for the IBD community as Rinvoq is the first JAK inhibitor indicated in both Crohn's disease and ulcerative colitis. Rinvoq offers people living with Crohn's disease a once-daily oral treatment capable of achieving important endpoints like clinical remission and endoscopic response, which can result in rapid and sustained symptom relief that makes a meaningful difference in a person's daily life."2 In summary, upadacitinib provides an oral option for patients with Crohn’s disease or ulcerative colitis who have had an inadequate response, loss of response or intolerance to at least one conventional and/or biologic therapy. Medical Letter consultants caution that serious adverse effects, including infections, malignancies, cardiovascular events and thromboses, are a concern with JAK inhibitors.5 Therefore, one or more TNF inhibitors should be tried first.5 References 1. AbbVie Corporation. Rinvoq (upadacitinib extended-release tablets) product monograph. St-Laurent, QC; October 11, 2023. (accessed October 24, 2023). 2. AbbVie Canada. AbbVie's Rinvoq (upadacitinib) receives Health Canada approval as the first and only oral therapy for the treatment of adults with moderately to severely active Crohn's disease. October 17, 2023. (accessed October 24, 2023). 3. Murdoch L. Rinvoq approved for use in moderately to severely active ulcerative colitis in adults. August 24, 2023. (accessed October 24, 2023). 4. Loftus Jr EV, Panés J, Lacerda AP, et al. Upadacitinib induction and maintenance therapy for Crohn’s disease. N Engl J Med 2023;388:1966-80. (accessed October 24, 2023). 5. Anon. Upadacitinib (Rinvoq): a second JAK inhibitor for ulcerative colitis. Med Lett Drugs Ther 2022;64:142-4.

Rinvoq (upadacitinib) now indicated for moderate/severely active Crohn’s disease

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