Gastroenterology

Researchers from Spain, where biosimilar use is encouraged as a way to save on costs and expand access to biologic therapies, recently reported on a multicenter prospective observational study in patients with inflammatory bowel disease (IBD) who switched from reference infliximab to a biosimilar, CT-P13 (Inflectra, Remsima). 
“I see no reason as a healthcare provider to intentionally go back and forth needlessly, but I see no concerns that, if I do that, bad things would happen,” said Jason Schairer, MD.
Crohn disease (CD) can involve physical, psychological, and social impairments that negatively impact patients’ quality of life, and high levels of anxiety and depression have been observed in patients with CD.
The question of whether to switch patients from a reference biologic to an available biosimilar has been the subject of extensive debate, especially in patients with inflammatory bowel disease (IBD), an indication in which evidence on relevant clinical outcomes after switching is limited.
 
Celltrion presented new research that demonstrates that a formulation of its infliximab biosimilar intended for subcutaneous administration is comparable to the intravenously administered option. The phase 1 study compared the subcutaneous formulation—which can be self-administered—with the FDA-approved intravenous formulation in patients with active Crohn disease (CD).
 
This week, the FDA approved an expanded indication of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz) to include adults with moderate to severe ulcerative colitis. Tofacitinib is the first oral medicine approved for long-term use in UC, and provides an alternative to anti–tumor necrosis factor (anti-TNF) drugs that must be injected or infused.
 
While it is already known that obesity may contribute to an increased risk developing some immune-mediated inflammatory diseases, as well as more severe disease activity and a higher burden of hospitalization, a new review found that obesity is also a predictor of inferior response to anti–tumor necrosis factor (anti-TNF) agents.
The authors of a recent study report that the addition of a disease-modifying anti-rheumatic drug (DMARD) or a switch to ustekinumab showed greater efficacy than changing anti–tumor necrosis factor (anti-TNF) treatments in patients with inflammatory bowel disease (IBD) who develop paradoxical arthritis. 
One of the main concerns attributed to anti–tumor necrosis factor (anti-TNF) treatment during pregnancy is the ability for the therapy to be transferred to the fetus. Complete immunoglobulin G (IgG) antibodies, both maternal and therapeutic, are delivered to the placenta during pregnancy naturally. This fact is important for patients who are treated with adalimumab, golimumab, and infliximab, which are complete IgG1 anti-TNF antibodies, and therefore transferred easily to the placenta. 
Although the benefits of originator infliximab have been deemed to outweigh the potential harm during pregnancy, in a recent observational study, researchers looked to evaluate whether biosimilar infliximab therapy was associated with any new safety risks.
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