Lana Pine is the editor of HCPLive Rheumatology. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. In her free time, she enjoys cooking, yoga, listening to podcasts, and drawing. She can be reached via email at LPine@mjhlifesciences.com.

Lana Pine

 or chronic inflammatory rheumatic disease treated with reference adalimumab who were switched to the 

 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.

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)

“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.

 “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.

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.

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.

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.

A total of 232 patients were included in the study, of which most (82%; n = 167) had either Crohn disease or ulcerative colitis, and 28% (n = 65) were diagnosed with a rheumatic condition, including 

 (n = 17), non-radiographic axial spondyloarthritis/

 (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.

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% CI, 0.26-0.48).

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%.

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; 

= .001). However, the HLS-EU-Q16 score was not linked to patient satisfaction (

“These results suggest that although satisfaction with switching was generally high, beliefs and concerns remain important and could lead to non-adherence,” investigators concluded.

 “Patient information and education should be reinforced before a switch to a biosimilar.”

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.

R. Neame, A. Hammond, Beliefs about medications: a questionnaire survey of people with rheumatoid arthritis, 

, Volume 44, Issue 6, June 2005, Pages 762–767, https://doi.org/10.1093/rheumatology/keh587

Articles

Health literacy was categorized as problematic in 36.2% of patients and insufficient in 15.1%.

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

Although most Israeli gastroenterologists do not have concerns about the safety and efficacy of biosimilars, most clinicians still preferred the brand name drug option, particularly regarding adalimumab, according to a study published in 

. Physicians are most opposed to switching to biosimilars in pregnant patients and those who have had difficulty achieving remission.

Biosimilars for inflammatory bowel disease (IBD) have been available in Europe since 2013, and the United States and Israel since 2016. They have been 

 conditions including gastroenterology, oncology, immunology, hematology, and inflammatory diseases.

“There is still insufficient evidence and a lack of clear guidelines regarding the preference of one drug over the other and regarding the replacement of the original drug with a biosimilar during treatment,” a team of Israeli investigators stated. “Many questions remain. Until enough evidence has accumulated from head-to-head comparisons, and until clear guidelines on the subject emerge, we decided to investigate the perception of Israeli gastroenterologists prescribing these drugs.”

A cross-sectional, 20-question survey was conducted among members of the Israeli Gastroenterology Association (IGA) between March and May 2022 regarding the prevalence of biosimilar uptake. The survey, sent via email, included questions about the decision to start a new biological treatment, switching between the originator and biosimilar, the clinician’s personal experience with biologic treatments, and demographic data, such as age, gender, and job position.

Of the 356 eligible gastroenterologists, 108 completed the questionnaire. The mean age was 47.6 years, 65% were men, 63% had more than 10 years of profession experience, and 45% worked in a hospital only. On average, physicians were treating 24 patients with IBD per month with biologics.

When asked about safety concerns, the average response was 2 on a scale in which 1 represented “not concerned” and 5 represented “concerned very much.” In total, 62% prescribed biosimilars to patients in the past year. Most (81%) of patients were biologically naïve and only 19% were switched to a biosimilar. When surveyed, 75% of gastroenterologists believed that the efficacy of biosimilars and biologics were the same. Thirteen percent believed that the originator was more effective, 2% thought the biosimilar was more effective, and 10% did not know.

When beginning a new biologic drug with no binding guidelines, over half (58%) of gastroenterologists preferred the brand name infliximab and 67% preferred the brand name adalimumab.

According to physicians, resistance to switching occurred in 19% of patients in remission over 2 years, 36% of pregnant women, 29% with active disease, and 70% of those with difficulty achieving remission. When a lack of response after switching occurred, most (78%) gastroenterologists decided to change the mechanism of action instead of returning to the brand name drug (21%).

The patient’s perspective regarding changing the drug to a biosimilar was rated 4.1 on average. The statement that there is enough information on biosimilars available from randomized controlled trials was rated a 3.3, and the desire to learn about biological drugs from reliable sources was rated a 4.0.

Investigators believed a strength of the study was the range of gastroenterologists across Israel that participated in the survey. However, the validity of the questionnaire remains uncertain. Further, they were unable to determine why some eligible doctors chose not to participate.

“With the rapidly gained momentum of biosimilars and the expected introduction of more biosimilars to the IBD field in the coming years, studies such as this one are very valuable,” investigators concluded. “Its utility is in both directing the coming studies to answer unsolved questions and in guiding the delivery of special educational knowledge to IBD practicing physicians to relieve their concerns.”

Richter V, Cohen DL, Bermont A, Shalem T, Broide E, Shirin H. The perception among Israeli gastroenterologists regarding treatment of patients with biosimilar medications. 

. 2023;59(3):523. doi:10.3390/medicina59030523

Although 75% of gastroenterologists believed that the efficacy of biosimilars and biologics were the same, most clinicians still preferred the brand name drug option.

Lana Pine

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

Most Israeli Gastroenterologists Prefer Reference Products Over Biosimilars