Infliximab Monotherapy Effective as Combo Therapy for Treating Inflammatory Bowel Disease
Researchers from Celltrion USA presented their post hoc analysis from the LIBERTY studies at the American College of Gastroenterology 2024 Annual Scientific Meeting.
Infliximab-dyyb (ZYMFENTRA®) monotherapy was just as effective as a combination therapy with immunosuppressants (IS) to treat Crohn’s disease (CD) and ulcerative colitis (UC), according to data presented in the post hoc analysis of the LIBERTY trials.1 With previous trials showing its efficacy over placebo for treating CD and UC, infliximab’s use as a monotherapy is now available as the first and only FDA-approved subcutaneous option for patients with inflammatory bowel disease (IBD).
“ZYMFENTRA, the first and only FDA-approved subcutaneous infliximab, had previously shown superior efficacy over placebo for maintenance therapy in patients with [CD] and [UC] in the randomized LIBERTY-CD and LIBERTY-UC studies. The new post hoc analysis explored the impact of baseline IS use by comparing outcomes between monotherapy and combination therapy,” according to a Celltrion USA news release.1
Infliximab is the first and only FDA-approved subcutaneous treatment for IBD. | image credit: Meeko Media / stock.adobe.com
A total of 429 individuals were included in the LIBERTY studies, including 192 (44.8%) patients with CD and 237 (55.2%) with UC. In the LIBERTY-CD study, 126 patients (65.6%) received infliximab as a monotherapy and 66 (34.4%) received the combination therapy. For the UC arm of the LIBERTY trial, 180 (75.9%) patients received the monotherapy while 57 (24.1%) were given the combination therapy.
READ MORE: Guselkumab’s Promising Results as First Subcutaneous IL-23 Inhibitor to Treat Crohn’s
“In both studies, there were no meaningful differences in efficacy outcomes between monotherapy and combination therapy at Week 54 or Week 102, despite combination therapy generally showing higher mean trough levels of infliximab after Week 10. Additionally, the overall safety profile was comparable between monotherapy and combination therapy throughout the pooled maintenance and extension phase,” wrote authors of the news release.1
Infliximab is currently approved for the subcutaneous treatment of patients with moderate-to-severe IBD following treatment with an infliximab product given by intravenous infusion. The medication is designed to serve as a blocker for tumor necrosis factor-alpha (TNF-alpha) actions, which can result in overproduction causing the immune system to target healthy parts of the body. Infliximab is given the “-dyyb” suffix to differentiate the ZYMFENTRA formula from other biosimilars.2
On October 22, 2023,3 the FDA approved the Biologics License Application (BLA) for infliximab, with self-injected route administration patented until 2040 and dosage form patented until 2037. It is currently recommended only for patients 18 years or older.1
However, according to LIBERTY trial data and the Celltrion USA news release, infliximab is not without its potential for infection and adverse reactions in specific patient populations.
“The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection,” read Celltrion USA’s news release.1 “Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions, and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection.”
Researchers also found that individuals taking infliximab could be susceptible to tuberculosis, disseminated or extrapulmonary disease, as well as fungal, bacterial, viral, or other infections.
“The new data strengthens the case for ZYMFENTRA monotherapy as a potential treatment option for patients with Crohn's disease and ulcerative colitis,” said Hetal Patel, PharmD, MBA, Head of Medical Affairs at Celltrion USA, to conclude the news release.1 “At Celltrion, we are committed to offering therapies that help patients and healthcare providers make informed, personalized treatment decisions. These findings suggest that ZYMFENTRA could offer flexibility in treatment approaches, providing confidence in monotherapy as an alternative to combination therapy, while maintaining effective disease control.”
READ MORE: Digestive Health Resource Center
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