Infliximab monotherapy has demonstrated comparable efficacy to combination therapy with immunosuppressants in treating Crohn's disease (CD) and ulcerative colitis (UC), according to a post hoc analysis of the LIBERTY trials. This finding supports the use of infliximab as a monotherapy, now available as the first and only FDA-approved subcutaneous option for patients with inflammatory bowel disease (IBD).
The LIBERTY studies included a total of 429 individuals, with 192 (44.8%) patients diagnosed with CD and 237 (55.2%) with UC. In the LIBERTY-CD study, 126 patients (65.6%) received infliximab as a monotherapy, while 66 (34.4%) received combination therapy. In the UC arm, 180 (75.9%) patients received monotherapy, and 57 (24.1%) were given combination therapy.
Efficacy and Safety
The analysis revealed no meaningful differences in efficacy outcomes between monotherapy and combination therapy at Week 54 or Week 102. According to the news release, combination therapy generally showed higher mean trough levels of infliximab after Week 10. The overall safety profile was comparable between both groups throughout the pooled maintenance and extension phase.
Infliximab functions as a tumor necrosis factor-alpha (TNF-alpha) blocker, preventing the immune system from targeting healthy parts of the body. The "-dyyb" suffix differentiates ZYMFENTRA from other biosimilars. Approved by the FDA on October 22, 2023, infliximab's self-injected route administration is patented until 2040, and its dosage form until 2037. It is currently recommended for patients 18 years or older.
Potential Risks
Despite its efficacy, infliximab carries potential risks of infection and adverse reactions, particularly in specific patient populations. Celltrion USA's news release stated, "The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection." The risk of infection may be higher in patients older than 65, those with comorbid conditions, and/or those taking concomitant immunosuppressant therapy. Clinical trials have reported serious infections, including arthritis bacterial, pneumonia, and urinary tract infection, in patients treated with infliximab.
Expert Commentary
"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. "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."
