‘No meaningful difference’: Zymfentra monotherapy as effective as combined therapy for IBD
Click Here to Manage Email Alerts
Key takeaways:
- No efficacy difference for IBD was found between infliximab-dyyb monotherapy or in combination with immunosuppressants.
- Safety was also comparable between monotherapy and combination.
PHILADELPHIA — Zymfentra as monotherapy was no more effective when combined with immunosuppressants for maintenance therapy in patients with Crohn’s disease or ulcerative colitis, according to post-hoc analysis presented here.
“[Zymfentra] is a subcutaneous form of infliximab, which has shown superior efficacy over placebo for maintenance therapy up to 1 year in patients who have moderate to severe Crohn’s disease or moderate to severe ulcerative colitis,” Bruce E. Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine and chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Icahn School of Medicine at Mount Sinai, told attendees. “Additionally, the drug was also effective and well-tolerated for long-term maintenance up to 2 years in these patients.”
To determine whether immunosuppressants improved the efficacy of Zymfentra (infliximab-dyyb, Celltrion) for patients with CD and UC, Sands and colleagues conducted a post-hoc analysis of the LIBERTY-CD and LIBERTY-UC studies.
The analysis included patients with either moderately to severely active CD (n = 192) or UC (n = 237) who had been randomly assigned to the infliximab-dyyb maintenance arm of the 54-week LIBERTY trials at week 10 and were treated in the open-label extension from weeks 56 to 102. The researchers then evaluated patient outcomes by their baseline immunosuppressant use, classifying these patients as combination therapy recipients.
In CD, 126 patients received monotherapy, while 66 received combination therapy; in UC, 180 received monotherapy and 57 received combination therapy.
“No meaningful differences in efficacy outcomes were observed for patients during maintenance who had a clinical response to infliximab induction either as monotherapy or in combination with immunosuppressants at week 54 and week 102,” Sands said.
Similarly, in combined analyses of patients with CD or UC, the researchers found no significant differences between safety profiles for monotherapy and combination therapy, with comparable treatment-emergent adverse events (80.8% vs. 79.5%), systemic injection reactions (3.8% vs. 1.6%) and infection (42.5% vs. 47.2%) reported in pooled maintenance and extension phases.
Although anti-drug antibody positive conversion rates were higher for patients on monotherapy vs. combination therapy at week 54 (71.7% vs. 49.6%) and up to week 102 (79.6% vs. 63.4%), “that did not translate to different efficacy outcomes,” noted Sands.
“By and large, monotherapy seems to do about as well as combination both at week 54 as well as at week 102,” Sands said. “Of course, it’s important to point out one limitation of this study: It was post hoc. Patients were not randomized or stratified upon their baseline use of concomitant immunosuppressants.”
Collapse
Sands BE, et al. Efficacy, safety and immunogenicity of subcutaneous infliximab (CT-P13 SC) monotherapy versus combination therapy with immunosuppressants: Post hoc analysis of LIBERTY-CD and LIBERTY-UC studies (late-breaking abstract). Presented at: ACG Annual Scientific Meeting; Oct. 25-30, 2024; Philadelphia (hybrid meeting).
Read more about
Click Here to Manage Email Alerts