Celltrion’s Inflectra, a biosimilar version of infliximab (Remicade), is both safe and effective in patients with inflammatory bowel disease (IBD), a recent study reported at the Digestive Disease Week 2016 meeting May 21-24 in San Diego, California. The data supports the use of the drug, which was recently approved by the U.S. Food and Drug Administration (FDA), proving it to be a viable and economic option to infliximab.
Biosimilars — compounds that can be considered interchangeable with a biological drug already approved by the FDA — are intended to provide competition, and tend to be more affordable medical solutions to patients. Their development is supported by the U.S. Patient Protection and Affordable Care Act. Inflectra was the second biosimilar approved by the FDA.
The study reported data from 90 patients with Crohn’s disease and 29 patients with ulcerative colitis who had never been treated with TNF-α blocking antibodies before. In addition to safety and tolerability aspects, the study, presented by Martin Bortlik from IBD Clinical and Research Centre in Iscare, Prague, explored the response to Inflectra at weeks 14 and 38.
Patients in the study had been ill an average of 6.2 years, and 38 percent had other disease manifestations in addition to their intestinal problems. As many as 27 percent had undergone surgical treatment, and 29 percent had experienced perianal disease.
At week 14, 28 percent of the Crohn’s disease, and 24 percent of the ulcerative colitis patients showed a complete response. A large group had a partial response — 62 and 52 percent, respectively — while only 10 percent of Crohn’s and 24 percent of ulcerative colitis patients did not respond at all.
At week 38, the numbers had increased to 44 percent of the remaining 64 Crohn’s patients, and 48 percent of the ulcerative colitis patients, showing a complete response. While the proportion of patients with a partial response decreased to 39 and 20 percent, respectively, the group of nonresponders grew to 17 percent of Crohn’s and 32 percent of ulcerative colitis patients.
“In total, we observed the response in 90 percent of Crohn’s disease patients and 76 percent of UC [ulcerative colitis] patients after induction treatment with biosimilar infliximab,” Bortlik said, according to a Healio Gastroenterology report from the meeting. “The response rate slightly dropped down at week 38 to 83 percent in Crohn’s disease patients and 68 percent in UC patients.”
Also, the rates of perianal disease dropped. At study start, 19 Crohn’s patients had active perianal disease. At week 38, 36.8 percent had improved and 47.4 percent had no lingering perianal symptoms left.
Bortlik also presented data showing that by week 14, a substantial proportion of patients exhibited mucosal healing. Other findings included lower levels of C-reactive protein and calprotectin after Inflectra treatment, indicating the drug harnessed the ongoing inflammation. The positive treatment effect allowed all but one of the Crohn’s patients and most ulcerative colitis patients to stop taking corticosteroids at week 38.
The number of adverse events were in the same range as for infliximab, and included hospitalization of five patients and skin lesions in 14 patients. A total of 14 patients, amounting to 8.9 percent of Crohn’s disease and 20.7 percent of ulcerative colitis patients, stopped the treatment prematurely.