Infliximab Biosimilar Safe, Efficacious for Patients with IBD

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In the infliximab reference group, the persistence at month 12 was 94% for Crohn’s disease and 92.8% for ulcerative colitis.

An infliximab biosimilar is showing promise in treating patients with inflammatory bowel disease (IBD) who are naïve to the biologic.1

A team, led by Yoram Bouhnik, Groupe Hospitalier Privé Ambroise Paré - Hartmann, Paris IBD Center, evaluated the persistence, effectiveness, and safety of Flixabi over 12 months in adults with IBD.


Flixabi (SB2) is a biosimilar of the reference infliximab that has shown promise treating patients with IBD. However, there is not much data in patients who are either infliximab naïve or transitioning from prior infliximab use.

The treatment is currently approved for the use of all indications that infliximab is currently approved, including rheumatoid arthritis (RA), Crohn’s disease (CD), ulcerative colitis (UC), ankylosing spondylitis, psoriatic arthritis, and psoriasis.

However, there is still a need for more data.

“Real-world data describing clinical outcomes in patients transitioning from reference biologics to corresponding biosimilars are important to inform the long-term effectiveness and safety of SB2 as treatment for patients with inflammatory bowel disease, both in treatment-naive individuals and in those transitioning from prior IFX therapy,” the authors wrote.


In the long-term, non-interventional, multicenter PERFUSE, the investigators examined patients treated with fliximab at specialist sites across France.

The patient population included 569 patients with Crohn’s disease and 168 participants with ulcerative colitis.

Treatment was initiated in September 2017, either as a first infliximab treatment, after transition from treatment with reference infliximab, or another infliximab biosimilar or both infliximab reference and infliximab biosimilar.

The investigators sought outcomes up to month 12, including persistence on flixabi, flixabi dose, disease status, immunogenicity, and safety.

The results show persistence at month 12 for Crohn’s disease was 89% (95% confidence interval [CI], 77.2-94.9) and 78.5% for ulcerative colitis (95% CI, 58.2-89.8) for patients who were naïve to infliximab.

In the infliximab reference group, the persistence at month 12 was 94% for Crohn’s disease (95% CI, 91.0-96.1) and 92.8% (95% CI, 84.8-96.7) for ulcerative colitis.

The results from the infliximab biosimilar group showed a persistence rate of 94% (95% CI, 91-96.1) for Crohn’s disease an d 92.8% (95% CI, 84.8-96.7) for ulcerative colitis.

Finally, in the infliximab multiswitch group, the persistence of Crohn’s disease was CD 100% (95% CI, 100-100), as well as 100% (95% CI, 100-100) for the ulcerative colitis group.

When examining disease activity, infliximab naïve had disease activity decline from baseline to month 12, while the proportions of patients in remission at baseline, month 6, and month 12 remained unchanged in patients with ulcerative colitis with any prior infliximab use and were comparable or higher in the Crohn’s disease cohort.

Finally, there were no immunogenicity or safety signals detected.

“Patients with IBD can be initiated on SB2 or transitioned from [infliximab reference] and/or [infliximab biosimilar] to SB2, with no loss of disease control or safety concerns, with >75% of naive and >90% of transitioned patients continuing on SB2 treatment at 12 months,” the authors wrote.



Bouhnik Y, Fautrel B, Beaugerie L, et al. PERFUSE: a French non-interventional study of patients with inflammatory bowel disease receiving infliximab biosimilar SB2: a 12-month analysis. Therapeutic Advances in Gastroenterology. 2023;16. doi:10.1177/17562848221145654