Remsima®, a biosimilar infliximab, shows efficacy and safety in “real world” analysis

by Bruce Sylvester – New “real world” data suggests that the efficacy of Remsima® (infliximab),  a biosimilar monoclonal antibody (mAb) anti-TNF-alpha agent approved by the European Commission, is similar to Remicade® (infliximab) in the treatment of IBD (Crohn’s disease and ulcerative colitis). 

Monoclonal antibodies are complex substances that bind to specific molecules, in the case of infliximab to tumor necrosis factor (TNF) alpha, a protein promoting the inflammatory response associated with auto-immune disorders. The data was presented in Vienna on Oct. 20, 2014 in a satellite symposium at UEGW 2014 (United European Gastroenterology Week).

Presenter Jørgen Jahnsen, MD, professor of gastroenterology at the University of Oslo in Norway, said, “Whilst biologics have become increasingly important as a treatment option for IBD, they are also expensive which may mean that some patients have limited access to them. The availability of a biosimilar anti-TNF-a could contribute to improving patient access to advanced biologic treatments.”

Dr. Jahnsen reported on disease activity at week 14 in 46 IBD patients, following 3 infusions of Remsima.

Of the 26 Crohn’s patients, 17 were women and 19 were men. Mean age was 37 years. Mean disease duration was 6.8 years.

Measures of disease activity for Crohn’s were changes in HBI (Harvey Bradshaw Index), calprotectin (a marker in the feces of gastrointestinal inflammation) and CRP (C-reactive protein).

Of the 20 ulcerative colitis patients, 7 were women and 13 were men. Mean age at diagnosis was 33 years. Mean age at start of treatment was 39 years. Mean disease duration was 5.6 years.

Measures of disease activity for ulcerative colitis were changes in Partial Mayo Score, Simple Activity Index and calprotectin.

He reported that the Crohn’s patients achieved significant improvements in HBI, calprotectin and CRP.

Likewise, the ulcerative colitis patients achieved significant improvements in Partial Mayo Score, Simple Activity Index and calprotectin.

No unexpected adverse events appeared during the 14 weeks of treatment and evaluation.

Dr. Jahnsen concluded that, “The efficacy and safety of Remsima in the treatment of IBD appears to be similar to Remicade.”

Remsima was approved by European Medicines Agency in June of 2013. And in September of 2013, The European Commission granted final authorization for commercialization for what is the first biosimilar monoclonal antibody to be approved by the European Commission for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

Remsima is currently licensed for use in Norway.