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.
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.
Image credit: sdecoret - stock.adobe.com
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.
Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results
August 21st 2024Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.
Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition
June 2nd 2024On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.
No Differences in Long-Term Drug Survival Between Biosimilar, Originator TNF Inhibitors
August 15th 2024An analysis of subcutaneous biosimilar and originator tumor necrosis factor (TNF) inhibitors for rheumatic diseases found no significant differences in survival or discontinuation rates due to inefficacy or adverse events, with biosimilars showing lower overall discontinuation rates and higher retention rates.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
CT-P13 Shows Similar Effectiveness, Safety in Biologic-Naive Patients With Crohn Disease
July 27th 2024Celltrion’s infliximab biosimilar CT-P13 demonstrates similar effectiveness and safety to the originator in biologic-naive patients with Crohn disease in a retrospective, real-world study in Japan.