Sometimes, no news is good news.

Such is the case with a recent Houston Methodist Hospital study evaluating the performance of infliximab-dyyb — a biosimilar version of the original biologic drug infliximab — as a treatment for inflammatory bowel disease (IBD).

Results from the prospective, observational, one-year clinical trial showed that both drugs performed similarly across all important metrics and demographic groups, confirming that long-term outcomes in a real-world clinical setting closely match earlier results from a randomized controlled trial.

"With IBD, you really don't want to mess with something that's working and risk moving your patient out of remission or endoscopic healing," says Dr. Bincy Abraham, principal investigator of the study and an IBD specialist at Houston Methodist Hospital. "It can be distressing to learn that a patient's insurance company wants them to switch to a new medication. We did this study to ensure that clinicians have enough real-world data to feel comfortable switching a patient's medication without unexpected or detrimental effects."

Unremarkable results welcome

For the study, researchers evaluated clinical outcomes (partial Mayo and Harvey Bradshaw index), patient-reported outcomes (short IBD questionnaire, treatment satisfaction, work productivity, anxiety and depression screening), health care resource utilization (hospitalizations, emergency department visits, gastroenterology appointments) and adverse events for 115 participants initiating infliximab-dyyb treatment for the first time.

Of the 67 participants with Crohn's disease (CD), 31% were biologic naïve, 54% switched from the original and 15% switched from a different biologic. Of the 48 participants with ulcerative colitis (UC), 37% were biologic naïve, 44% switched from the original and 19% switched from a different biologic.

In both CD and UC, patients switching from the original to the biosimilar maintained their clinical outcomes and patient reported outcomes.

Among biologic-naïve patients, clinical outcomes improved for UC and were maintained for CD, while both disease types showed improvements in patient-reported outcomes.

Adverse events, IBD-related hospitalizations, ED visits and gastroenterology appointments occurred at rates consistent with known profiles for the original drug.

"This is exactly what we expected — and wanted — to see," Dr. Abraham says. "You want the biosimilar's efficacy to be the same as the original, because if it suddenly produced significantly better results, it would no longer be a biosimilar. This is simply an evidence-based study that confirms what we already knew from the randomized controlled trials, and that's highly reassuring to providers."

Infliximab impact on quality of life

In addition to being one of the first known studies to evaluate the real-world performance of infliximab-dyyb in North American patients with IBD, this is one of only a few studies on biosimilars to incorporate quality of life data.

"Post-approval non-interventional studies evaluating comparative outcomes can play a key role in building a real-world evidence base to help inform clinical practices and policy decisions," Dr. Abraham explains. "There never seems to be enough quality-of-life data published on IBD treatments, but it's very important for clinicians to know that patients are happy with a treatment, side effects are minimal, and productivity and absenteeism are improved."

Cost of treatment is another significant real-world concern for clinicians, patients and insurance carriers alike.

"Most patients switch to biosimilars for reasons related to reimbursement, insurance coverage or high out-of-pocket costs," Dr. Abraham says. "Biosimilars should have similar effectiveness and ideally be less expensive than the reference product, as we consider their use to be an important opportunity to increase access to quality care for our patients."