Biosimilar Safety and Efficacy Comparable to Biologic Treatment in IBD Patients

Biologic compounds have long been considered the gold standard immunosuppressive therapy for moderate-to-severe inflammatory bowel disease (IBD), but growing evidence suggests that biosimilars offer similar benefits at a much lower cost. Now, a new study by Cleveland Clinic physicians comparing the biologic compound infliximab with the biosimilar infliximab-abda shows that the two therapies are comparable in both safety and efficacy.

“We found that biosimilars are equivalent to bio-originators in terms of how the patients experience it, and how well they tolerate the drug,” says first author Ruthvik Padival, MD, an advanced IBD fellow at Cleveland Clinic.

The study looked at patients being treated at Cleveland Clinic for IBD including Crohn’s disease and ulcerative colitis in 2018 and 2019. Researchers identified 99 patients who were switched from infliximab to infliximab-abda for non-medical reasons, mainly due to changes in insurance coverage.

Similar results for both drugs

They found that patients did not exhibit an increase in medication use (prednisone for evidence of an IBD flare or pain medications for worsening pain) following the switch, and the patients’ median c-reactive protein (CRP) was similar before and after changing therapies. This was true both for all patients and for patients who had a CRP greater than 1.

Infliximab drug concentration and antibody levels were similar pre- and post-switch, as were the patients’ endoscopic scores for both Crohn’s disease and ulcerative colitis. Finally, acute healthcare utilization, determined by the number of emergency department visits and hospitalizations, was similar after patients switched to infliximab-abda.

The researchers did identify that some patients needed a slightly higher dose of the biosimilar than they did of the bio-originator, but more studies are needed to determine the significance of this finding and if there are optimal dosing recommendations in IBD patients, Dr. Padival says.

“There’s been a lot of biosimilar research done in Europe suggesting that, overall, biosimilars are equivalent in terms of disease efficacy, including endoscopic activity,” says Cleveland Clinic gastroenterologist Taha Qazi, MD, coauthor on the study. “But this is the first situation where we had a large hospital system in the United States that switched from a bio-originator to a biosimilar.”

Limitations to the study include the fact that it only included patients who had made a single medication switch. It also only looks at patients who had been doing well on their therapy, or who had only recently started the bio-originator therapy.

Next steps for the research

Next, Dr. Padival says he wants to take a more detailed look at specific disease characteristics and clinical symptoms in patients who switch to biosimilars. But, he says, the new study is an important first step in looking at biosimilars as a potentially cost-saving alternative for patients.

“Historically, biologics have been the mainstay of therapy for moderate-to-severe IBD,” he says. “But now we’re noticing a shift, where patients can experience very similar—if not within the range of extremely similar—results from biosimilar compounds that are not only equally effective, but also have a very similar safety profile and potentially lower cost.”