Rinvoq approved for use in moderately to severely active ulcerative colitis in adults

Health Canada has approved a new indication for AbbVie’s Rinvoq (upadacitinib extended-release tablets). The Janus kinase (JAK) inhibitor is now indicated for the treatment of moderately to severely active ulcerative colitis in adults who have an inadequate response to, loss of response to, or intolerance to at least one of conventional and/or biologic therapy.1,2 Rinvoq was also approved earlier for several other indications: treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and atopic dermatitis.1 Health Canada’s approval for upadacitinib use in ulcerative colitis was based on results from three Phase 3 studies, two for induction (U-ACHIEVE induction and U-ACCOMPLISH) and one maintenance study (U-ACHIEVE maintenance). In clinical trials, patients taking upadacitinib achieved the primary endpoint of clinical remission (per modified Mayo Score) at weeks 8 and 52. Safety results in the ulcerative colitis trials were generally consistent with the known safety profile of upadacitinib, with no new important safety risks observed.2 Upadacitinib is dosed in two phases for adults with moderately to severely active ulcerative colitis. The induction dosage is 45 mg once daily for eight weeks. This is followed by a maintenance dosage of 15 mg once daily. The tablets can be taken with or without food, at any time of the day. However, the tablets should be swallowed whole, not split, crushed or chewed.1 For some patients (e.g., those with refractory, severe or extensive disease), a maintenance dosage of 30 mg once daily may be appropriate. The lowest effective dose needed to maintain response should be used. The drug should be discontinued if a response is not maintained with the 30 mg dose. For patients ≥ 65 years of age, the only recommended maintenance dose is 15 mg once daily.1 In mid-September, AbbVie plans to release a new 45 mg upadacitinib extended-release tablet for induction dosing in adults with ulcerative colitis. The new strength will join the existing 15 mg and 30 mg upadacitinib extended-release tablets.1 References 1. AbbVie Corporation. Rinvoq (upadacitinib extended-release tablets) product monograph. St-Laurent, QC; July 19, 2023. (accessed August 24, 2023). 2. AbbVie Canada. Health Canada approves AbbVie's Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis. July 25, 2023. (accessed August 24, 2023).

Rinvoq approved for use in moderately to severely active ulcerative colitis in adults

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