Rationale for Correct Answer
The correct answer is: Subcutaneous injection of vedolizumab is approved in several non-US countries
A subcutaneous form of vedolizumab is approved for use in Japan and Europe for treatment of UC and CD, and it was recently resubmitted for FDA-approval for UC.1 An oral formulation of the active ingredient in vedolizumab is currently in phase 2 trials.2 Both risankizumab and mirikizumab are selective IL-23 inhibitors.3,4 Risankizumab has demonstrated efficacy in patients with CD and UC.3,5 Mirikizumab has demonstrated efficacy in a phase 3 trial in UC and is currently being studied in a phase 3 trial in CD.2,4
References:
1. Takeda press release. April 27, 2023. https://www.takeda.com/newsroom/newsreleases/2023/takeda-announces-fda-acceptance-of-bla-resubmission-for-investigational-subcutaneous-administration-of-entyvio-vedolizumab-for-maintenance-therapy-in-moderately-to-severely-active-ulcerative-colitis/. Accessed October 9, 2023;
2. Clinicaltrials.gov;
3. D’Haens G et al. Lancet. 2022;399(10340):2015-30;
4. D’Haens G et al. N Engl J Med. 2023;388(26):2444-55;
5. Ferrante M, et al. Lancet. 2022;399(10340):2031-46;
6. Abbvie press release. June 15, 2023. Available at: https://news.abbvie.com/news/press-releases/risankizumab-skyrizi-met-primary-and-key-secondary-endpoints-in-52-week-phase-3-maintenance-study-in-ulcerative-colitis-patients.htm#:~:text=The%20COMMAND%20study%20is%20a,to%20severely%20active%20ulcerative%20colitis. Accessed October 2, 2023.