Study Observes Low Switch Back Rates in Infliximab Biosimilar ABP 710

Patients with inflammatory bowel disease (IBD) who received the infliximab biosimilar ABP 710 (infliximab-axxq) persisted on treatment during a median follow-up period of 295 days. The majority of patients switched from the originator, although the switch back rate back to the reference drug was generally low. Investigators noted that reasons for switching and differences in patterns between infliximab-naïve patients and those who switched were unknown and continue to warrant future research.

ABP 710 is a US Food and Drug Administration (FDA)-approved drug for the treatment of IBD-related, immune-mediated diseases such as Crohn’s disease (CD) and ulcerative colitis (UC).

“Approval of IFX biosimilars for CD and UC treatment was based on the principle of extrapolation without indication-specific comparative clinical trial data,” wrote Ran Jin, MD, PhD, observational research senior manager at Amgen Inc, and colleagues, in an abstract presented at Digestive Disease Week (DDW) 2023. “Postmarketing real-world evidence can provide useful information to the medical community.”

The retrospective analysis, which used the Optum claims database, included adult patients with either a CD or UC diagnosis, which was verified using ICD-10 diagnostic codes. Eligible patients received ABP 710 between July 2020 and December 2021 and had ≥183 days of uninterrupted enrollment both pre- and post-ABP 710 treatment. Information on patient demographics and prior medication use were collected at baseline.

Kaplan-Meier analysis was used to analyze persistence and switching patterns post-ABP 710 initiation were reported using descriptive statistics. Outcome measures were categorized at baseline by previous experience with the infliximab originator: patients without (infliximab-naïve) or with (switchers) prior exposure to the reference drug.

Of the 472 patients included in the study, 329 had a CD diagnosis and 143 had UC. Most (83.9%) were classified as switchers and 16.1% were infliximab-naïve. The median age was 43 years, most (78.0%) were White, and 46.6% were women. The baseline use of all examined products, which included nonsteroidal anti-inflammatory drugs, corticosteroids, 5-aminosalicylic acid, oral immunosuppressants, and targeted therapies, was higher in the infliximab-naïve cohort when compared with switchers.

During the study follow-up period, 74.5% of switchers and 51.3% of infliximab-naïve patients remained on ABP 710 treatment without a treatment gap. A proportion (5.3%) of patients resumed ABP 710 after taking a drug holiday, which was defined as >90 days of a predefined permissible treatment gap.

Infliximab treatment or other targeted therapies were completely discontinued in 19.7% of infliximab-naïve patients and 6.1% of those in the switchers cohort. A total of 23.7% of infliximab-naïve patients and 14.1% of switchers moved to another advanced therapy, with investigators observing a varied switching patterns between both cohorts.

Switchers most often switched back to the reference drug (10.4%) and patients in the infliximab-naïve group most often switched to tumor necrosis factor inhibitor (TNF) biologics (10.5%).

References

1. ^{JinR, ArvizuM, Harris Collier D, Melmed G, et al. EP146: TREATMENT PATTERNS OF AN INFLIXIMAB BIOSIMILAR (ABP 710) AMONG PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD): A RETROSPECTIVE US CLAIMS DATABASE ANALYSIS. Abstract presented at Digestive Disease Week (DDW) 2023 Annual Meeting. Chicago, IL. May 6-10, 2023.}