Biosimilar Education Needed for Pediatric Patients With IBD and Caregivers

Not only did a majority of each group say they hadn’t heard of biosimilars, but those who had heard of them had negative perceptions.

Education among providers around the safety and efficacy of biosimilars has been important for uptake of these agents, but education among patients and caregivers is also crucial. A study published in Journal of Pediatric Gastroenterology and Nutrition found that not only had a majority of pediatric patients and caregivers not heard of biosimilars, but those who had heard of them were more likely to have a negative perception.

The study assessed perspectives among patients aged 11 to 21 years with inflammatory bowel disease (IBD) and the caregivers of patients with IBD between the ages of 3 and 21 years. The patients were being treated with the anti–tumor necrosis factor (TNF) originator product.

The authors noted that past studies have found adults with IBD were also unfamiliar with biosimilars and had a negative perception and that pediatric providers in IBD were less comfortable than adult providers with using biosimilars. “This is likely because anti-TNF biosimilars are relatively new in gastroenterology and early studies were conducted in adult patients with rheumatoid arthritis,” they explained.

The cross-sectional survey included 14 questions and was conducted among participants at Nationwide Children’s Hospital in Columbus, Ohio. The analysis included responses from 98 caregivers and 67 patients. Of the patients, 46 of their caregivers also filled out the survey.

Caregivers were slightly more familiar with biosimilars, although 64% had still never heard of biosimilars compared with 79% of patients. The majority of patients on the originator had been on it for at least 2 years (70% according to patients and 63% according to caregivers). The respondents also felt the originator had worked well, with 76% of patients and 70% of caregivers choosing “very well” and 22% of patients and 26% of caregivers choosing “well.”

There was a lot of uncertainty among patients and caregivers:

  • 55% of caregivers and 66% of patients chose “unsure” in response to the statement “I am very comfortable switching from Remicade (infliximab) to a biosimilar"
  • 64% of caregivers and 73% of patients chose “unsure” in response to “I would prefer to use a biosimilar than Remicade (infliximab)”
  • 86% of caregivers and 87% of patients chose “unsure” in response to “I think a biosimilar would have more side effects than Remicade (infliximab)”
  • 82% of caregivers and 78% of patients chose “unsure” in response to “I think biosimilars would treat my/my child’s disease just as well as Remicade (infliximab)”
    • This is the only statement in which patients agreed (18%) more than disagreed (4%)

While receiving information about how biosimilars had an equivalent efficacy to the originator made more patients and caregivers comfortable with the idea of switching to a biosimilar, 48% of caregivers and 30% of patients remained concerned about more adverse effects with a biosimilar. Information about the lower cost of biosimilars didn’t change the comfort level anymore.

Among caregivers who had heard of biosimilars, the perception was strongly negative. Although 27% of caregivers who had never heard of biosimilars disagreed with the statement “I am very comfortable switching from Remicade (infliximab) to a biosimilar,” that proportion increased drastically to 57% among caregivers who had previously heard of biosimilars. Similarly, only 20% of caregivers who had never heard of biosimilars disagreed with “I would prefer to use a biosimilar than Remicade (infliximab)” compared with 57% of caregivers who have heard of them.

“Educating patients and caregivers about biosimilars and improving negative impressions of biosimilars are vital as insurance companies are frequently requesting that patients undergo a nonmedical switch from the originator to a biosimilar,” the authors concluded. They added, “Negative feelings toward an intervention may affect patient outcomes in a multitude of ways, including worsening symptoms, which is referred to as the ‘nocebo effect.’”

Reference

Yossef L, Wright M, Benedict J, et al. Patient and caregivers' perspectives on biosimilar use in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. Published online April 20, 2022. doi:10.1097/MPG.0000000000003462