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Review shows biosimilar infliximab safe, effective in IBD
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Inflectra demonstrated “excellent clinical efficacy and safety” in patients with inflammatory bowel disease, according to the results of a systematic review and meta-analysis.
Inflectra (CT-P13/infliximab-dyyb; Celltrion) is a biosimilar of Remicade (infliximab, Janssen) approved by the FDA last year. It is marketed in the U.K. as Remsima, and is currently approved in more than 75 counties.
Atsushi Sakurab, MD, PhD, along with Yuga Komaki, MD, both of the section of gastroenterology, hepatology and nutrition, department of medicine, University of Chicago Medicine, and colleagues reviewed safety and efficacy data of biosimilar infliximab in patients with IBD, published up to May 2016, and included 11 observational studies in their meta-analysis (n = 829 patients).
“Meta-analyses of the efficacy among these studies showed that induction of clinical response in Crohn’s disease and ulcerative colitis was achieved in over 70% of patients at short (8-14 weeks) and medium (24-30 weeks) terms,” Sakurab said in a press release.
At 8-14 weeks the pooled clinical response rates were 0.79 (95% CI, 0.65-0.88) among patients with Crohn’s disease and 0.74 (95% CI, 0.65-0.82) among patients with ulcerative colitis, and at 24-30 weeks they were 0.77 (95% CI, 0.63-0.86) and 0.77 (95% CI, 0.67-0.85), respectively.
“Analysis of safety also showed that adverse effects related to CP-T13 were rare,” Komaki said in the press release.
Adverse event rates were 0.08 (95% CI, 0.02-0.26) in Crohn’s disease and 0.08 (95% CI, 0.03-0.17) in ulcerative colitis.
“Furthermore, the pooled rates of sustained clinical responses after switching from infliximab to CT-P13 remained high at 75% to 96% through a period of 1 year,” Komaki added.
At 30-32 weeks, sustained clinical response rates after switching were 0.85 (95% CI, 0.71-0.93) for Crohn’s disease and 0.96 (95% CI, 0.58-1) for ulcerative colitis, and at 48-63 weeks they were 0.75 (95% CI, 0.44-0.92) and 0.83 (95% CI, 0.19-0.99), respectively. Adverse events were also rare in patients who switched: 0.1 (95% CI, 0.02-0.31) in Crohn’s disease and 0.22 (95% CI, 0.04-0.63) in ulcerative colitis.
“Further studies are needed, but the results of our study support the use of CT-P13 in the treatment of IBD,” the investigators concluded.
These findings are in line with randomized controlled trial data recently presented at the 12th Congress of the European Crohn’s and Colitis Organization, and data from a switching study presented last year at UEG Week 2016. – by Adam Leitenberger
Disclosures: Komaki reports he was supported by the Pediatric Oncology Research Fellowship of the Children’s Cancer Association of Japan.
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