Europe Leading the Way on Biosimilars for Bowel Diseases

Damian McNamara

March 18, 2016

AMSTERDAM — European studies are showing that there are no significant changes in outcome after patients with inflammatory bowel disease switch to a biosimilar from more expensive antibody therapies, according to results presented during a packed session here at the European Crohn's and Colitis Organisation 2016 Congress.

"In the short- to medium-term, all is fine. The response is high and the immunomodulation is in line" with reference antibodies, said session comoderator Alessandro Armuzzi, MD, from Complesso Integrato Columbus Catholic University in Rome.

"What we do not know is the long-term effect on immunogenicity," Dr Armuzzi told Medscape Medical News. He said he is reserving final judgment until 2-, 3-, and 4- year data come in.

"I'm not expecting anything surprising, but we need to have long-term data," he said.

In the United States, biosimilar agents could soon be moving beyond the preclinical stage. The approval of an infliximab (Remicade, Janssen Biotech) biosimilar, called CTP-13, was recently supported by a US Food and Drug Administration advisory panel, and the agency generally follows the panel's guidance.

Because 20 biosimilars are currently approved in Europe, American physicians are looking for data from their European colleagues who are already using these agents to treat patients with inflammatory bowel disease. In general, the picture looks promising.

'No Surprising Signals'

In a prospective 1-year study of 291 patients in Hungary, the clinical response rate with CTP-13 was 47% in patients with Crohn's disease and was 46% in those with ulcerative colitis.

"CTP-13 effectively maintains clinical remission and response in both Crohn's disease and ulcerative colitis," said Krisztina Gecse, MD, PhD, from Semmelweis University in Budapest.

Efficacy tended to be better in patients naïve to anti-TNF-alpha treatment, she reported. There were significant reductions in mean C-reactive protein levels by week 14 in patients with Crohn's disease and in those with ulcerative colitis; this was maintained throughout the 54-week study.

"There were no surprising signals in adverse events," Dr Gecse said. In fact, the "adverse-event profile and rates were comparable to the originator based on historical cohorts." The most common events were respiratory tract infection, reported by eight patients, gastroenteritis, reported by six, and viral infection, reported by three.

The Netherlands Experience

Findings were also positive in a prospective observational study of 78 patients conducted in the Netherlands. There were no significant changes in quality of life, trough levels of the therapy, or adverse events at 16 weeks.

"The switch from Remicade to CTP-13 in a real-life cohort of inflammatory bowel disease patients did not have a significant impact on short-term outcomes," said Lisa Smits, a student researcher at Radboud University Medical Center in Nijmegen. On the basis of these data, switching is feasible, she added.

The median change in disease activity score was zero, as were absolute changes in the Harvey-Bradshaw Index (HBI) for Crohn's disease and the Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis.

Five patients discontinued CTP-13, which generated some discussion after the presentation. "Of the five who stopped, three had progression of antidrug antibodies that were already present at baseline," Smits reported. In addition, one participant moved abroad and another withdrew from the study because of disease remission.

'Effective and Safe'

Results from a study conducted in the Czech Republic largely mirrored those from the other studies.

There was no difference in disease activity scores or laboratory measures 24 weeks after 74 patients with inflammatory bowel disease switched from infliximab to biosimilar therapy, said Martin Kolar, MD, from Charles University in Prague.

More important, no increase in immunogenicity was observed. Two patients discontinued therapy — one because of acute relapse and the other because of eosinophilic inflammation.

The leading adverse event after a switch to the biosimilar was joint pain, seen in seven patients, but it was a chronic condition and not new-onset joint pain.

"We continue to monitor up to week 48, and so far, there has been no evidence that switching patients leads to worse outcomes or any adverse events," Dr Kolar explained.

Dr Gecse, Ms Smits, Dr Kolar, and Dr Armuzzi have disclosed no relevant financial relationships.

European Crohn's and Colitis Organisation (ECCO) 2016 Congress: Abstracts OP028, OP030, and OP032. Presented March 17, 2016.

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