Questionnaire Identifies Higher Risk of Biosimilar Treatment Discontinuation

Questionnaires given to patients receiving the adalimumab biosimilar SB5 early on in treatment were useful in identifying those at higher risk of treatment discontinuation before 12 months, according to a study published in Digestive and Liver Disease.¹

Yoram Bouhnik, MD, PhD

Credit: Clinical Trials Mobile Application (CTMA)

Inflammatory bowel disease (IBD) has increased globally over the past few decades, with an estimated 250,000 to 300,000 cases in France alone. Although conventional therapy usually includes biologic medications, including tumor necrosis factor inhibitors (TNF) like adalimumab, the high cost of these drugs is often a detriment for patients.²

“Biosimilars are functionally similar molecules to biologics which represent more affordable alternatives to the reference products,” wrote Yoram Bouhnik, MD, PhD, Groupe Hospitalier Privé Ambroise Paré - Hartmann, Paris IBD Center, and colleagues. “[They] are therefore a pharmaceutical opportunity that should not be overlooked. However, consolidating data on their long-term safety and effectiveness, especially in indications other than the one which served for the authorization process are welcomed by authorities.”

The long-term, observational PERFUSE (NCT03662919) study enrolled 318 adult patients with Crohn’s disease (CD) and 88 adult patients with ulcerative colitis (UC) across 27 tertiary care sites in France between October 2018 and December 2020. Patient-reported outcome measures (PROMs) were used to understand patient training and satisfaction, including perception of their interactions with their physicians, perception of their illness, beliefs about medicine, as well as assess their impact on 12-month persistence on the biosimilar. The Perceived Efficacy in Patient-Physician Interactions questionnaire (PEPPI) evaluated the quality of communications between patients and physicians.

The online questionnaire (ePRO) was designed with patient associations and sent out at 1-month post-baseline. Higher scores were indicative of higher confidence and satisfaction. Information on treatment persistence was collected during routine clinical visits up to 15 months after treatment initiation. Findings were categorized by prior experience with subcutaneous biologic medications and proper injection device training.

A total of 145 (57.1%) naïve patients and 67 (44.1%) pre-treated patients responded to the ePRO. Baseline characteristics were similar among respondents and non-respondents, although there was a higher proportion of females in the respondent group population.

Naïve patients were more likely to be offered training when compared with the pre-treated cohort (86.9% [n = 126/145] vs 31.3% [n = 21/67], respectively; P <.05), although disparities were observed between sites. Among the naïve patient group, 96.8% (n = 122/126) attended the training session.

Satisfaction scores among both cohorts were high, with no statistically significant differences observed regarding confidence of using the injection device and satisfaction in overall care between subgroups. Patients also reported being similarly satisfied with the information they received on biosimilars (naïve cohort: 8.2; pre-treated cohort: 8.7).

Patients who completed the survey were significantly more likely to achieve 12-month persistence on SB5 when compared with non-respondents (68.0% [60.9; 74.1] vs 52.3% [44.5; 59.6]; P <.05). Higher persistence rates were also seen in patients with a better perception of their illness (odds ratio [OR] = 1.02, [1.0; 1.05]; P <.05).

Investigators noted the observational real-world design limited the study as it relied on already available data coupled with the patient’s choice of completing the optional survey, which led to low response rates. Information such as quality of life and adverse events under previous treatment were not collected. Further, investigators were unable to examine the reasons for discontinuation, immunogenicity, and safety data.

“Early online patient questionnaires may help identify patients at a higher risk of non-persistence who may require closer follow-up,” investigators concluded. “Recent changes in the regulatory landscape in France, with the introduction of a pay-per-performance model, may change switching practices, warranting further investigation.”

References

1. ^{Bouhnik Y, Carbonnel F, Fumery M, et al. The PERFUSE study: The experience of patients receiving Adalimumab biosimilar SB5 [published online ahead of print, 2023 Jun 10]. Dig Liver Dis. 2023;S1590-8658(23)00657-6. doi:10.1016/j.dld.2023.05.025}
2. ^{Cai Z, Wang S, Li J. Treatment of inflammatory bowel disease: a comprehensive review. Front Med. 2021; 8765474}