Patients with IBD who revert to infliximab after biosimilar more likely to quit treatment
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Key takeaways:
- Results showed 22.7% of patients who reinitiated infliximab after biosimilar use discontinued treatment due to unwanted response.
- Disease remission drove discontinuation among 2.3%.
Patients with inflammatory bowel disease who reinitiated infliximab treatment after using a biosimilar had a threefold increased risk for discontinuation over time due to unwanted response, according to research.
“Despite the fact that many patients in clinical practice successfully transitioned from infliximab originator to biosimilar, studies have demonstrated that on average 7% of patients with IBD who transitioned subsequently retransitioned to originator infliximab (ie, they stopped the biosimilar and reinitiated the originator),” Rosanne W. Meijboom, of the Pharmacy Foundation of Haarlem Hospitals in the Netherlands, and colleagues wrote in Therapeutic Advances in Gastroenterology. “It is unclear if retransitioning is related to the drug product or to the patient and his/her disease.”
In a noninterventional, multicenter cohort study, researchers compared the risks and reasons for infliximab discontinuation among patients with IBD who reinitiated treatment with the originator vs. those who remained on a biosimilar between January 2015 and September 2019. They identified 198 individuals (median age, 39.9 years; 53% women) who transitioned from infliximab to a biosimilar, of whom 24.7% switched back to the originator during follow-up (median, 8.6 months).
After matching, there were 44 patients in the retransitioning cohort (median age, 39.9 years; 65.9% women; median dosing interval, 48.5 days) and 127 patients in the biosimilar cohort (median age, 44 years; 48.9% women; median dosing interval, 56 days).
Results showed that 22.7% of those in the retransitioning cohort discontinued treatment because of unwanted response compared with 13.4% in the biosimilar cohort, while 2.3% and 9.4%, respectively, discontinued due to disease remission.
Compared with patients in the biosimilar cohort, patients in the retransitioning cohort were at increased risk for overall discontinuation because of unwanted response (adjusted HR = 3.7; 95% CI, 1-13.9).
Researchers noted patients who retransitioned due to an increase in objective disease markers had higher discontinuation rates (66.7%) compared with patients who retransitioned because of symptoms alone (23.7%).
“Our study demonstrated that patients who retransitioned discontinued infliximab treatment more often due to unwanted response compared with patients who remained on biosimilar, whereas patients who remained on biosimilar discontinued infliximab more often due to remission,” Meijboom and colleagues concluded. “Patients who retransitioned have, over time, over a threefold increased risk for discontinuing infliximab due to unwanted response compared with patients who remained on biosimilar.”
They continued: “These findings indicate that retransitioning is mainly related to the patient and/or his/her disease, including patients’ beliefs on the biosimilar, and less likely related to the infliximab biosimilar itself.”
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