Biosimilar Shows Efficacy Treating Inflammatory Bowel Disease

The Remicade biosimilar inflectra (infliximab) appeared safe and effective for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC) across 38 weeks, according to a presentation at Digestive Disease Week 2016.

Researchers from Prague retrospectively analyzed anti-tumor necrosis factor (anti TNF) therapy naïve patients between January 2015 and January 2016 to understand the effects of infliximab in 90 CD patients and 29 UC patients.

The researchers collected data at 14 weeks and 38 weeks, and patients had been diagnosed for an average of about six years. About a third of the patients had additional disease manifestations on top of their intestinal condition.

The drug had been approved in Europe since 2013 and was recently approved by the FDA in April 2016.

Using endoscopy, the researchers learned that 28% of the CD patients had completely responded by week 14, while 62% had a partial response, though 10% had no response.

By week 38, 44% of the CD patients had a complete response, 39 showed a partial response, and 17 had no response.

A quarter of the ulcerative colitis patients had a complete response by week 14, while half had partial response, and the remaining quarter had no response. After 38 weeks, half had a complete response, 20% had partial response, and a third had no response.

At baseline, about a quarter of the patients had surgical treatment and 29% experienced perianal disease. By 38 weeks, only three patients’ were unchanged — seven CD patients with active perianal disease improved and nine resolved.

All patients except one with CD, and a “majority” of the UC patients were able to withdraw their steroids by week 38, the researchers reported. Adverse side effects included hospitalization (five patients), skin lesions (14 patients), though the researchers noted that this was the same as the originator biologic. Fourteen patients discontinued treatment.

“Biosimilar infliximab is effective in IBD patients naive to anti-TNF,” Martin Bortlik, MD, PhD said during his presentation. “This is a population which was naive to prior anti-TNF, but ... there are several reports reassuring us of the data in patients already treated.”