Approximately Half of Patients Demonstrated Poor Health Literacy Prior to Biosimilar Switch

A real-world study showed patients with inflammatory bowel disease (IBD) or chronic inflammatory rheumatic disease treated with reference adalimumab who were switched to the biosimilar CT-P17 generally believed the switch was a treatment necessity. Higher satisfaction rates were observed among those who were convinced of the necessity compared with those with greater concerns about treatment.¹

However, health literacy levels were categorized as either problematic or insufficient in 51.3% of patients with longer disease duration and long-standing biologic use, according to data presented at the 2024 European Congress of Rheumatology (EULAR).¹

“Switches to biosimilars are not always well-accepted by patients,” wrote a team of investigators led by Laure Gossec, MD, PhD, professor of rheumatology in Sorbonne Université and Pitié-Salpêtrière Hospital, France.¹ “Patients’ beliefs, concerns, and knowledge about health could impact their satisfaction towards switching.”

To assess the beliefs about medicine and health knowledge that may influence a patient’s satisfaction post-switch to a biosimilar, investigators conducted the prospective, multicenter, observational YU-MATTER study. The French study enrolled patients with IBD or chronic inflammatory rheumatic disease who were treated with the reference drug or a biosimilar with low concentration (50 mg/mL). These patients were then switched to CT-P17, a high concentration and citrate-free formulation, for 3 months.¹

The primary outcome was patient satisfaction after the 3-month trial period, which was evaluated through a 7-point Likert scale. The Beliefs About Medicines Questionnaire (BMQ) was used to assess patient beliefs prior to the switch, including any concerns and perceived necessity.¹

The BMW is a validated tool that has been shown to predict treatment adherence. The assessment consists of 2 5-item scales, in which a score of 1 represents “strongly disagree” and 5 represents “strongly agree,” that evaluate the necessity of a prescribed medication for managing their disease as well as worries about adverse effects.²

Patients’ knowledge was determined using the 16-item European Health Literacy Survey Questionnaire (HLS-EU-Q16). Any association between beliefs and/or knowledge and satisfaction with the switch was assessed using the Wilcoxon test.¹

A total of 232 patients were included in the study, of which most (82%, n = 167) had either Crohn’s disease or ulcerative colitis, and 28% (n = 65) were diagnosed with a rheumatic condition, including rheumatoid arthritis (n = 17), non-radiographic axial spondyloarthritis/psoriatic arthritis (n = 13), or radiographic axial spondyloarthritis (n = 35). Among the cohort, the median disease duration was 9 years, the median age was 43 years, and approximately half of patients (49.6%) were women. The median total adalimumab duration prior to the switch was 47 months.¹

The scores of both the BMQ and HLS-EU-Q16 were comparable across patient characteristics, including the type of disease, disease duration, duration of adalimumab treatment, age, and sex. The link between the HLS-EU-Q16 score and the BMQ necessity/concerns differential was moderate (Spearman coefficient: 0.37, 95% confidence interval [CI]: 0.26 - 0.48).¹

Before the switch to the biosimilar, patients reported an overall positive view of the drug, as determined by the BMQ-necessity score being higher than the BMQ-concerns score. Health literacy was deemed adequate in 48.7% of patients; however, it was categorized as problematic in 36.2% and insufficient in 15.1%.¹

At the end of the trial, most (76.2%, n = 144/189) were satisfied with the switch to CT-P17. Unsurprisingly, the median necessity/concerns differential was higher among those who were satisfied with the switch compared with unsatisfied patients (+6 vs +3, respectively; P = .001). However, the HLS-EU-Q16 score was not linked to patient satisfaction (P = .12).¹

“These results suggest that although satisfaction with switching was generally high, beliefs and concerns remain important and could lead to non-adherence,” investigators concluded.¹ “Patient information and education should be reinforced before a switch to a biosimilar.”

References

1. ^{Gossec L, Bouguen G, Marotte H, Foulley, et al. Perceived Need for Treatment is Associated with Patient Satisfaction After a Switch to a Biosimilar; Health Literacy is Often Limited: A Prospective Multicentre Observational Study of 232 Patients. Presented at: EULAR. Vienna, Austria. June 12 – 15, 2024.}
2. ^{R. Neame, A. Hammond, Beliefs about medications: a questionnaire survey of people with rheumatoid arthritis, Rheumatology, Volume 44, Issue 6, June 2005, Pages 762–767, https://doi.org/10.1093/rheumatology/keh587}