Outcomes after double switching from originator Infliximab to biosimilar CT‐P13 and biosimilar SB2 in patients with inflammatory bowel disease: a 12‐month prospective cohort study

Abstract

SummaryBackgroundThere are few data regarding multiple switching from the originator Infliximab to its biosimilars.AimTo assess outcomes and patient perspectives in a prospective manner after double switching from Infliximab to the biosimilars CT‐P13 and SB2.MethodsA total of 158 consecutive patients with inflammatory bowel disease (IBD) receiving CT‐P13 maintenance therapy were switched to SB2 and followed for 54 weeks. Patients were stratified according to previous switch from the originator Infliximab to CT‐P13 (double switch group) or not (single switch group).ResultsThe drug persistence was high (94.9%) after 54 weeks. In total, 17 (10.8%) patients experienced loss of response to SB2, including 10 patients who were managed through dose optimisation and continued treatment. No changes were observed in clinical activity scores, fatigue, biological activity and pharmacokinetical parameters after the switch. The safety profile was in line with the current knowledge of Infliximab. According to the Beliefs about Medicines Questionnaire, the patients’ perspectives did not change after switching from CT‐P13 to SB2. The primary patient concerns remained after the switch, which were focused on effectiveness and safety rather than on the molecular differences between originator and biosimilars or socioeconomic benefits. There were also no differences in the concerns and beliefs between the double and single switch groups.ConclusionDouble switching from the originator Infliximab to CT‐P13 and then to SB2 was not associated with an impairment in patient beliefs, while the effectiveness, immunogeniity and safety of anti‐TNF therapy remained stable after 54 weeks of follow‐up.

Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus

“…Statement 6 relied on the concept of interchangeability. Interchangeability allows a biosimilar product to be replaced by the reference product [19,20], making multiple switches from one biosimilar to another feasible in cases of drug unavailability [21][22][23].…”

476 Multiple Infliximab Biosimilar Switches Appear to Be Safe and Effective in a Real-World Inflammatory Bowel Disease Cohort

“…Single switch from IFX originator trials. 5,6 For double switches the data comes from observational cohorts 13,20,21 and no data on IBD an triple switch has been reported yet. For this reason clinicians have relied on real-world cohort studies despite limitations.…”

“…Further evidence that supports a comparable effectiveness of double switching from originator to CT-P13 to SB2, compared to a single switch comes from a study involving 158 patients, 115 of whom had two switches and 43 a single switch. 21 All patients were at the moment of switch in sustained steroid-free clinical remission for at least 6 months. IFX persistence was 94.9% after median follow-up, which is slightly 90.6%).…”

“…28 Moreover, IFX levels remained stable after switching. 14,21 Our study has several strengths including its prospective nature and the large sample size. Furthermore our study provides data for patients with a single switch, double switch and a triple switches.…”