Posters Capture Clinical Impacts of Infliximab in Super-Responders, Pregnant Patients With IBD

Posters from Digestive Disease Week 2024 look at how super-responders and pregnant patients with inflammatory bowel disease (IBD) react to treatment with subcutaneous infliximab and an infliximab biosimilar, respectively.

IBD is an umbrella term for Crohn disease (CD) and ulcerative colitis.

Super-Responders to Subcutaneous Infliximab¹

The first study, the LIBERTY-CD study, demonstrated that subcutaneous infliximab (CT-P13 SC; Zymfentra; infliximab-dyyb; Remsima SC) maintenance therapy significantly benefits patients with moderate to severe active Crohn disease who responded to intravenous infliximab induction.

A post hoc analysis of 231 patients from the CT-P13 SC arm used group-based trajectory modeling to identify different response patterns. Four distinct trajectories were found: super-responders (n = 61), fast responders (n = 56), slow responders (n = 63), and limited responders (n = 51), stabilizing around weeks 10 to 14.

Super-responders showed the highest rates of clinical remission (73.8%; P = .002), endoscopic response (63.9%; P = .009), corticosteroid-free remission (63.6%; P = .007), and comprehensive disease control (42.6%; P = .094) at week 54. They also maintained the highest trough levels of infliximab throughout the maintenance period.

Baseline characteristics associated with super-response included lower body weight, body mass index, and oral corticosteroid use, but higher Crohn's Disease Activity Index scores and prior biologic/Janus kinase inhibitor use. The researchers said that the analysis underscores the potential for CT-P13 SC to provide substantial long-term benefits for certain subpopulations of patients with CD.

Infliximab Biosimilar in Pregnant Patients²

In the second study, the researchers confirmed that infliximab biosimilars do not result in compromised health outcomes or developmental milestones in pregnant patients with IBD. This study aimed to compare pregnancy outcomes for women with IBD using biosimilar infliximab vs the originator (Remicade) from 2017 to 2023, using data from the PIANO cohort.

The analysis was a multicenter prospective cohort that collected demographic information, IBD history, infliximab treatment type, pregnancy outcomes, congenital malformations, and developmental milestones for the first year of the child's life. Among the 89 women included, 76 used originator infliximab, and 13 used biosimilar infliximab during pregnancy. Both groups had similar clinical characteristics, with about two-thirds having Crohn disease and the rest having ulcerative colitis.

No significant differences in overall pregnancy complications were observed between the 2 groups. While more women on originator infliximab had a cesarean delivery (37% vs 15%), this difference was not statistically significant. Developmental milestones at 12 months showed no differences in communication, motor skills, social interaction, or problem-solving between the groups.

The researchers concluded that the new information could provide people with IBD who may wish to get pregnant reassurance about the safety of using infliximab biosimilars.

References

1. Schreiber S, Sands BE, Hanuaer SB, et al. Super-responders in patients with moderate-to-severe Crohn's disease treated with subcutaneous infliximab maintenance therapy: a post hoc analysis of the LIBERTY-CD study. Presented at: DDW 2024; May 18-21, 2024; Washington, DC. Poster Su1767.

2. Long MD, Kane SV, Beaulieu D, Abraham BP, Zhang X, Mahadevan U. Use of biosimilars to infliximab during pregnancy in women with inflammatory bowel disease. Presented at: DDW 2024; May 18-21, 2024; Washington, DC. Poster Mo1871.