Long-term Studies Back Biologic-to-Biosimilar Switch

Damian McNamara

November 01, 2017

BARCELONA — For patients with inflammatory bowel disease, switching between innovator infliximab and its biosimilar CTP-13 is safe, and outcomes are similar regardless of the pattern of switching, results from a phase 3 study show.

This is the first randomized controlled trial to confirm previous research, said Alex Kudrin, MD, PhD, a biopharmaceutical consultant in Brighton, United Kingdom.

"There have been a lot of concerns about switching," he pointed out. "Although there have been observational studies with biosimilars for infliximab, there have been no randomized controlled trials comparing innovator infliximab with its biosimilar. That's why the results of this study are quite important," he said here at United European Gastroenterology Week 2017.

Dr Kudrin and his colleagues compared long-term responses, remission rates, and safety data for 220 patients with inflammatory bowel disease who were randomly assigned to one of four treatment regimens. Fifty-six patients remained on CT-P13 throughout the 1-year study, 54 remained on infliximab, 55 switched from CT-P13 to infliximab at week 30, and 55 switched from infliximab to CT-P13 at week 30.

All patients — who were from Europe, South Korea, the United States, and other countries — had moderate to severe disease at baseline. The use of immunomodulators and corticosteroid therapy was balanced between treatment groups.

The proportion of patients who achieved the primary outcome — a reduction in Crohn's Disease Activity Index (CDAI) score of at least 70 by week 6 — was not significantly different between the four treatment groups.

At week 54, there were no statistically or clinically significant differences in response between treatment groups.

There was no difference in clinical remission — a secondary end point — in the four treatment groups. Although levels of calprotectin and C-reactive protein decreased from baseline, there were no significant differences in degrees of decline. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores — another secondary end point — did not differ significantly between groups at baseline or at week 6, week 14, week 30, or week 52.

Safety Results

"In terms of safety, there were no new safety signals, and the incidence was similar between groups in terms of adverse drug reactions, adverse events, and serious adverse events," Dr Kudrin reported.

Infections were similar at 30 weeks and up to 1 year, regardless of switching pattern, he added. No deaths were reported during the study. Only a few infusion-related reactions occurred, but they were unrelated to the switching pattern.

"Importantly, immunogenicity was similar between patients who switched to CT-P13 or to innovator infliximab," said Dr Kudrin. All those antibodies were neutralized.

We have been waiting for a long time to see if we can switch without any disadvantages for the patients.

"We have been waiting for a long time to see if we can switch without any disadvantages for the patients," said session comoderator Johan Burisch, MD, from the University of Copenhagen.

However, "the patient numbers were small, so there still might be questions about whether the safety profile continues to be as beneficial as we've seen today," he told Medscape Medical News.

Updated Results From the Nor-Switch Trial

During a late-breaking research session, 18-month results from the Nor-Switch trial were presented by Kristin Jørgensen, MD, from Akershus University Hospital in Lørenskog, Norway.

In the extension trial, 183 people took the originator infliximab for 52 weeks and then switched to CT-P13 for 26 weeks, and 197 patients took CT-P13 for the full 78 weeks.

The rate of disease worsening was lower in the switch group than in the continuous group (12% vs 17%).

Disease-specific composite measures and trough drug levels did not differ between groups. Likewise, treatment-emergent adverse events, most often mild infections, did not differ significantly between groups. And there were no differences detected in anti-drug antibodies during the study period. No patients died during the study period.

"The study showed comparable efficacy, safety, and immunogenicity in patients switching from originator infliximab to CT-P13 and patients on long-term CT-P13 treatment," Dr Jørgensen explained.

"These results support switching from infliximab to CT-P13 for nonmedical reasons," she added. However, she cautioned, these results should not be generalized to other biosimilars.

Dr Kudrin is a consultant for Celltrion. Dr Burisch and Dr Jørgensen have disclosed no relevant financial relationships.

United European Gastroenterology (UEG) Week 2017. Presented October 30, 2017.

Follow Medscape Gastroenterology on Twitter @MedscapeGastro and Damian McNamara @MedReporter

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