Individuals with inflammatory bowel disease (IBD) and treating clinicians both acknowledge strong satisfaction ratings of the adalimumab biosimilar known as ABP 501 among both treatment initiators and switchers, according to recent findings.¹

These findings were the results of an analysis into real-world data on ABP 101’s biosimilarity to adalimumab, given that while data existed on its use in those with rheumatoid arthritis and psoriasis, further information for IBD patients and clinicians was seen as necessary.

The investigators acknowledge that European IBD specialists' confidence in use of biosimilars has increased, though a survey of US gastroenterology advanced practice providers indicated concerns such as more than 60% reporting discomfort in switching patients over.² To address these issues, the new analysis on satisfaction of ABP 501 was led by Ran Jin, from Amgen Inc. in Thousand Oaks, California.

“In this current study, we evaluated the real-world experience of ABP 501 use in patients with CD or UC in five major European countries from both physicians’ and patients’ perspectives with regard to patient clinical status, treatment satisfaction, and HRQoL,” Jin and colleagues wrote.

Background and Methods

The investigators examined data in this study that were drawn from the 2020–2021 Adelphi IBD Disease Specific Programme, a survey of gastroenterologists as well as their patients in Spain, France, Italy, Germany, and the UK. This survey had been carried out in the period between September 2020 - June 2021, and it was preceded by a validated methodology previously detailed.

The clinicians involved in this research had actively been taking part in treatment of individuals with Crohn's disease (CD) and ulcerative colitis (UC). Subjects of this analysis found to be eligible for inclusion in the team’s research were at least 18 years old, with a confirmed diagnosis of either CD or UC, and these individuals were not enrolled in a clinical trial at the time of consultation.

The clinicians involved were instructed by the investigators to fill out patient record forms for 5 - 8 consecutive subjects with CD and 5 - 7 consecutive UC patients, regardless of their treatment. Another set of individuals given ABP 501 was also used to ensure a sufficient number for the research team’s analysis.

The clinicians recorded their data through abstraction of patients’ clinical records, and they supplemented the data through their perspectives given to the investigators. Subjects voluntarily filled out their questionnaires to report on their own health-related quality of life (HRQoL).

Findings

The investigators’ work involved 239 subjects starting ABP 501 and 136 who were instructed to switch from RP-ABP 501. Those who had initiated were given ABP 501 for a median of 7.5 months during the treatment period, while those labeled as ‘switchers’ had been given it for a median of 7.7 months post-switch from the RP’s median of about 14.0 months.

The research team reported that about 74% of those labeled as ‘initiators’ and 89% of those in the switcher cohort were shown to be in clinical remission through reports by their clinicians. Notably, both they and their patients were also found to have expressed high satisfaction with the biosimilar, with the range being around 92% - 99%.

Using the Short IBD Questionnaire, the EuroQol visual analogue scale, and the Work Productivity and Activity Impairment scoring system, the subjects of the research were shown to have indicated minimal impairment of their HRQoL while on the biosimilar. Lastly, the investigators found the main reason for subjects’ switching from RP to ABP 501 was reported as lower costs.

“This study provides real-world evidence to help reassure both patients and physicians that the patient experience associated with the use of ABP 501 appears similar to that with the RP, regardless of whether the patient is initiated on ABP 501 or has switched from the RP to ABP 501,” they wrote.

References

1. ^{Jin, R., Nduka, C., Courmier, D. et al. Real-World Experience of Adalimumab Biosimilar (ABP 501) Use in Patients with Inflammatory Bowel Disease in Europe. Adv Ther (2023). https://doi.org/10.1007/s12325-023-02712-w.}
2. ^{Bernasko N, Clarke K. Why is there low utilization of biosimilars in inflammatory bowel disease patients by gastroenterology advanced practice providers? Crohns Colitis 360. 2021;3(4):otab004.}