Digesting 2022 and looking forward to 2023 in IBD therapeutics
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The past year has seen quite a few new developments in inflammatory bowel disease therapy.
The SEAVUE head-to-head trial of ustekinumab vs. adalimumab for Crohn’s disease demonstrated that both biologics were highly effective in inducing clinical remission in biologic-naïve patients with moderate to severe activity. The SERENE trials showed that a higher induction dose of Humira (adalimumab, AbbVie) was no more effective than the standard induction dose for inducing clinical remission in both ulcerative colitis and CD. A higher maintenance dose (40 mg weekly) was slightly more effective than the approved maintenance dose for maintaining remission in UC.
Rinvoq (upadacitinib, AbbVie), one of the selective Janus kinase 1 inhibitors, was shown to be highly effective at inducing and maintaining clinical remission in moderate to severe UC, regardless of previous biologic exposure. Upadacitinib was approved by the FDA in March 2022 for moderate to severe UC among those who had previously tried an anti-tumor necrosis factor agent. In my own clinical practice, this has been a big game-changer.
Skyrizi (risankizumab-rzaa, AbbVie), a monoclonal antibody to the p19 subunit of interleukin-23, was found to be effective at inducing and maintaining clinical remission in moderate to severe CD and was approved by FDA in June 2022. The results of several phase 3 programs were presented at international meetings this year, and it is likely that some of these programs will lead to drug approvals in 2023.
Mirikizumab (Lilly), a monoclonal anti-IL-23 antibody, was shown to be effective for both induction and maintenance of clinical remission in moderate to severe UC. Etrasimod (Pfizer), a sphingosine-1-phosphate receptor modulator, appears to be a safe and effective agent for UC. It is anticipated that both agents could be approved for UC in 2023.
Other important developments to anticipate in 2023 include the introduction of as many as eight adalimumab biosimilars to the U.S. market, which almost certainly will drive the price of adalimumab down, and the potential approvals of subcutaneous Entyvio (vedolizumab, Takeda) and Inflectra (infliximab-dyyb, Celltrion) for the treatment of IBD.
These therapeutics have already been approved in multiple other regions including Europe. It will be interesting to see what effect the availability of the adalimumab biosimilars and subcutaneous vedolizumab and infliximab-dyyb will have on treatment algorithms, especially if the cost differences are significant.
I suspect it will take time for us to “digest” all these new developments, and the publication of real-world experiences with these new agents will help shape our clinical practice. Here’s looking to 2023!
- References:
- Danese S, et al. Lancet. 2022;doi:10.1016/S0140-6736(22)00581-5.
- D’Haens GR, et al. Gastroenterology. 2022;doi:10.1053/j.gastro.2022.01.044.
- D’Haens G, et al. Lancet. 2022;doi:10.1016/S0140-6736(22)00467-6.
- Ferrante M, et al. Lancet. 2022;doi:10.1016/S0140-6736(22)00466-4.
- Panes J, et al. Gastroenterology. 2022;doi:10.1053/j.gastro.2022.02.033.
- Sands BE, et al. Lancet. 2022;doi:10.1016/S0140-6736(22)00688-2.
- For more information:
- Edward V. Loftus Jr., MD, is professor of medicine at the Mayo Clinic in Rochester, Minnesota, and chief medical editor for Healio Gastroenterology.
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