Biosimilar Infliximab Appears Safe, Effective in IBD Patients

By Anne Harding

NEW YORK (Reuters Health) - There is no change in drug levels and disease activity in patients with inflammatory bowel disease (IBD) taking Remicade after they are switched to a biosimilar version of the medication, according to new findings.

“In my personal opinion, that should be the standard of care, for patients to receive an infliximab biosimilar, if prices of innovator drugs remain as high as they are,” Dr. Luc Derijks of Maxima Medical Center in Veldhoven, the Netherlands, who helped conduct the study, told Reuters Health in a telephone interview. He noted that the biosimilar version of the medication is less than half of the cost of Remicade.

The European Union has approved Inflectra (from Hospira, Lake Forest, Illinois, USA) and Remsima (from Celltrion Healthcare, Incheon, South Korea) based on studies in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS), Dr. Derijks and his team note in Alimentary Pharmacology & Therapeutics, online December 5.

While the EU extrapolated the approval from these registration studies to all conditions treated with Remicade, they add, physicians have been reluctant to switch to the less expensive version because there have been few studies in IBD patients.

Dr. Derijks and his colleagues enrolled 133 IBD patients at two hospitals who were on Remicade, switching them to Inflectra as part of routine care and following them with proactive therapeutic drug monitoring before the first, second, fourth and seventh dose of biosimilar. Patients received a letter from their gastroenterologist informing them of the plan to switch and explaining that the drugs are “highly similar.” While a few patients had “severe doubts,” they were persuaded to switch after further discussion of biosimilars.

The researchers followed patients for 12 months, during which time 35 stopped taking the drug, in most cases related to subjective higher disease activity (rarely confirmed objectively with higher scores) or adverse events. Adverse events included general malaise and fatigue, in seven patients, and arthralgia, skin problems and infusion reactions, each in two patients.

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There were no statistically different differences in disease activity or drug levels when patients were on Remicade compared to when they were on Inflectra.

Eight patients had antibodies to infliximab and were switched to a different treatment.

Baseline levels of IFX varied widely, the researchers found, with some patients having undetectable levels and others having very high levels. Based on a therapeutic range of 3-7 micrograms/mL, they note, 40% of patients were within this range.

“A relatively high proportion of patients discontinued biosimilar therapy within the first year, but this is probably due to the nonblinded setup of our study and the fact that a real-life cohort was monitored rather than a well-defined and preselected population, which induces the nocebo effect,” the authors note. From 10% to 20% of patients stop taking Remicade every year, Dr. Derijks added.

Using proactive therapeutic drug monitoring could help clinicians optimize treatment with infliximab and its biosimilars, Dr. Derijks said, and may well be cost-effective. “That should be examined in well-defined studies,” he said.

The researchers reported no personal or funding interests.

SOURCE: https://bit.ly/2ksQxkY

Aliment Pharmacol Ther 2017.

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