Faced with switching to a biosimilar medication, children and adolescents with juvenile arthritis (JA) and their parents were primarily concerned about the use of a new, unknown device, and worried that the therapy’s color resembled other medicines with known side effects, a study shows.
Their concerns were alleviated by reassurance from trusted medical staff, the study found.
The study, “Same but different? A thematic analysis on adalimumab biosimilar switching among patients with juvenile idiopathic arthritis,” was published in the journal Pediatric Rheumatology.
Juvenile idiopathic arthritis (JIA) — the idiopathic meaning the cause is unknown — comprises a group of chronic inflammatory conditions in children that affect the joints, causing swelling, stiffness, and pain.
Some children with JIA will be diagnosed with uveitis, an inflammatory condition that causes swelling and destruction of ocular tissues, mainly in a part of the eye called the uvea. Early uveitis symptoms include eye pain, blurry vision, and sensitivity to light, but the condition can lead to vision loss.
However, these biological medicines are expensive, which can limit their broader use. In response, generic versions — called biosimilars — are becoming more readily available.
Biosimilars are not clinically different regarding quality, safety, and efficacy. However, reports have suggested that patients’ perceptions of a new medicine can cause them to reject the medication — called failed switching. This can limit therapeutic options, increase healthcare usage and cost, and have a negative effect on patient outcomes.
Therefore, before the NHS switched to the biosimilar treatment for JIA, U.K. researchers designed an interview-based study to better understand how children and adolescents with the disease, and their parents, perceived biosimilar switching.
A total of nine JIA patients — all with uveitis, between the ages of 6 and 17, and regularly taking Humira — and their families were interviewed about their perceptions of biosimilar switching. Patients were interviewed together with their parent(s) and questions were directed at all participants.
After interviewing the families, the team identified five main themes that affected patients’ and parents’ perceptions of the switch to a biosimilar: medicine administration, specifically the device and formulation; concerns about possible ineffectiveness and side effects; benefits, particularly regarding access and cost; equivalence, or concerns that it was the same medicine; and trust in the clinical staff.
Administration of the medicine using a different, unfamiliar device was the children’s primary concern. One parent said, “I wasn’t sure whether there’s going to be an option of prefilled syringe and pen device … we are using a prefilled syringe … she said she would like to stick with that.”
Some children recalled a stinging sensation caused by a preservative in previous versions of Humira. One parent said to a child, “Your concerns as well have been about ‘just tell me it’s not going to hurt anymore’ or … about whether it’s stingy or not.”
Several families expressed concern about the yellow color of the medication, which is similar to the color of methotrexate, an anti-inflammatory medicine. That medication was associated with negative side effects by some of the patients. As one parent said, “… if it is yellow, he’s not going to go near it.”
Anxiety about potential side-effects in switching from the known to the unknown also was frequently mentioned. “It’s not ideal because you know that something works and it really is just to know that it’s not going to have the side effects,” said one parent.
Other concerns were expressed about the potential to switch back to the original medication in the event of poor outcomes, and the availability of the new medicine.
While some families were worried the biosimilar would be not be as good as the original, many agreed with one parent who said, “Just because it is cheaper doesn’t mean that it is inferior.”
Participants identified the cost savings, improved medicine accessibility, and resources used elsewhere as benefits of switching. As one parent pointed out, “Now that there is somebody else out there they might not have to fight to get the drug that their kids deserve. It is good.”
With respect to equivalence — the medicine being the same — most respondents did not have serious concerns. “For me, it is the same drug but by a different supplier so it doesn’t really make any difference so I do not mind at all,” one parent said.
For many participants, trust in the medical staff alleviated their concerns about biosimilar switching, and families most resistant to the changeover did not blame the staff. One parent said, “They wouldn’t let you have something that’s not going to work.”
Based on these results, the researchers provided recommendations for biosimilar switching. These included biosimilar teaching for all staff, written and verbal patient education before switching, information for families regarding disease and medication, and drug availability. They also encouraged teaching the practical aspects of using different device types, and urged that patients and their families be informed by familiar medical staff rather than anonymous administrators.
“The themes identified in our study may assist with proactively addressing patient expectations during medication counselling and patient education programs in order to minimise the incidence of failed switching and contribute to an improved patient experience,” the researchers said.