May 2024

Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: Results from three Phase 3, multicentre, double-blind, randomised trials

Lancet 2022;399(10341):2113–28 doi: 10.1016/S0140-6736(22)00581-5

The results of two induction studies (UC1 and UC2) and a maintenance study (UC3) show upadacitinib superiority to placebo in treating ulcerative colitis (UC). Rates of clinical remission were significantly higher for all upadacitinib doses versus placebo in all three studies.

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Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): A phase 2b/3 double-blind, randomised, placebo-controlled trial

The Lancet 2021;397:2372–2384 doi: 10.1016/S0140-6736(21)00666-8

Treatment of patients with UC with filgotinib 200 mg was associated with an increase in clinical remission at Week 10 and Week 58. The proportion of patients with clinical remission at Week 58 was significantly greater in patients who continued FIL 200 mg therapy throughout the trial. The incidence of TEAEs was similar across all treatment groups.

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Tofacitinib as induction and maintenance therapy for ulcerative colitis

N Engl J Med. 2017 May 4;376(18):1723-1736. DOI 10.1056/NEJMoa1606910

Tofacitinib, at a dose of 10 mg twice daily, was more effective than placebo for induction of remission and mucosal healing in patients with moderately to severely active ulcerative colitis. Furthermore, maintenance therapy with tofacitinib, at a dose of either 5 mg or 10 mg twice daily, was more effective than placebo in sustaining remission and mucosal healing.

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January 2024

Implementation of Regulatory Guidance for JAK Inhibitors Use in Patients with Immune-Mediated Inflammatory Diseases: An International Appropriateness Study

Autoimmun Rev. 2023;23(3):103504 doi: 10.1016/j.autrev.2023.103504 Epub ahead of print

In this two-round modified RAM study by Solitano, et al., the authors found that experts preferred to assess JAK inhibitor risk on a case-by-case basis across all specialties. Uncertainty remained on several clinical scenarios regarding the appropriate use of JAK inhibitors, however they remain an important therapy option for the treatment of IMIDs  and were deemed appropriate for patients with moderate risk profiles.

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April 2023

Identification of Two Tofacitinib Subpopulations with Different Relative Risk Versus TNF Inhibitors: An Analysis of the Open Label, Randomised Controlled Study ORAL Surveillance

Ann Rheum Dis. 2023;82(7):901-910 doi: 10.1136/ard-2022-223715

Findings from a post hoc analysis of ORAL Surveillance can help guide individualised benefit/risk assessment and clinical decision-making on treatment with tofacitinib, based on identification of subpopulations ‘at risk’.

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January 2023

Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs

Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00507-z

This post-hoc analysis of 31 clinical trials in ulcerative colitis, rheumatoid arthritis and psoriatic arthritis concludes that combined influenza adverse event incidence rates were highest in ulcerative colitis, while in each indication they were generally similar across tofacitinib, placebo, and comparator groups.

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