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Infliximab biosimilar safe, effective in Crohn’s disease, UC

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SAN DIEGO — Use of Inflectra, a biosimilar to Remicade, appeared safe and effective out to 38 weeks in patients naive to anti-tumor necrosis alpha therapies, according a presenter at Digestive Disease Week 2016.

“Biosimilar infliximab is effective in IBD patients naive to anti-TNF,” Martin Bortlik, MD, PhD, IBD Clinical and Research Centre, Iscare, Prague, 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.”

Bortlik reported retrospectively on data from January 2015 to January 2016 on consecutive patients with IBD who were treatment-naive and treated with CT-P13 (Inflectra, Celltrion), a biosimilar to Remicade (infliximab, Janssen). The biosimilar has been approved in Europe since 2013 and just gained approval by the FDA in April 2016.

This study looked at response at week 14, using endoscopy to measure a physical change, and week 38, using biologic response levels. Prior to the start of treatment, mean disease duration was 6.2 years, 38% of patients had extra-intestinal manifestations, 27% underwent surgical treatment and 29% of the patients with Crohn’s disease had a history of perianal disease.

At week 14, Bortlik showed 28% of patients with Crohn’s (n = 90) responded completely, 62% had at least a partial response and 10% had no response. At week 38, 44% of patients with Crohn’s (n = 64) had complete response, 39% had partial response and 17% had no response.

In ulcerative colitis, at week 14, 24% of patients (n = 29) had complete response, 52% had partial response and 24% had no response. At week 38, 48% had complete response, 20% had partial response and 32% had no response.

“In total, we observed the response in 90% of Crohn’s disease patients and 76% of UC patients after induction treatment with biosimilar infliximab,” Bortlik said. “The response rate slightly dropped down at week 38 to 83% in Crohn’s disease patients and 68% in UC patients.”

At week 0, 19 patients with Crohn’s had active perianal disease. At week 38, seven patients (36.8%) improved and nine patients (47.4%) resolved. Only three patients were unchanged.

“More than 80% of Crohn’s disease patients with perianal disease improve substantially by week 38,” Bortlik said.

Bortlik also showed mucosal healing as based on endoscopic examination at week 0 and then again at week 14: “All patients had Mayo two or Mayo three and one half of them improved so that they had Mayo 0 or Mayo 1, meaning they had mucosal healing at week 14.”

C-reactive protein measured at week 0 and week 38 also improved in both groups (Crohn’s disease, P = .0001; UC, P = .0361), as did fecal calprotectin (Crohn’s disease, P = .0211; UC, P = .0188).

When looking at trough levels for the biosimilar, Bortlik showed a continuous decline from week 2 at 20.9 ± 12.4 µg/mL to week 38 at 5 ± 5.6 µg/mL. At week 38, 8.6% of patients were adalimumab antibody-positive, Bortlik said.

“All but one patient with Crohn’s disease and the majority of UC patients could withdraw their steroids at week 38,” he added.

Adverse events ranged from hospitalization (five patients) to skin lesions (14 patients), but Bortlik said they were “exactly the same” as the originator biologic. Treatment was discontinued in 14 patients (12%), 8.9% of patients with Crohn’s disease and 20.7% of patients with UC. – by Katrina Altersitz

Reference:

Bortlik M, et al. Abstract #515. Presented at: Digestive Disease Week; May 21-24, 2016; San Diego.

Disclosures: Bortlik reports no relevant financial disclosures.