Researchers Present Findings on Switching to CT-P13 in IBD

This week, the European Crohn’s and Colitis Organisation (ECCO) will hold its 14th Congress in Copenhagen, Denmark. During the meeting, which runs from March 6-9, experts will gather from around the globe to discuss significant medical research into the treatment of inflammatory bowel disease (IBD), and numerous researchers will present findings on real-world switches to biosimilar infliximab CT-P13 (Inflectra, Remsima).

UK Study Reports a Smooth Switch

Among researchers who will discuss CT-P13 are investigators from a single center in the United Kingdom who performed a retrospective review of patients who were switched from reference infliximab to CT-P13.¹ In the study, 96 patients were switched. At the time of the switch, 76 patients had normal C-reactive protein (CRP), and 15 had elevated CRP.

Eight months after the switch, 80 patients remained in biochemical remission, and in 14 patients, CRP had increased. In total, 72 patients achieved clinical remission, and of 51 who underwent endoscopic assessment, 31 had achieved mucosal healing.

At 13 months, 69 patients remained on the biosimilar, while 10 had discontinued to due immunogenicity, 5 stopped infliximab after loss of response, 5 discontinued in order to undergo surgery, 5 discontinued after achieving remission, and 2 discontinued due to adverse events (AEs). One patient died due to hospital-acquired pneumonia.

According to the authors, the biosimilar was well tolerated, and clinical efficacy and loss of response for CT-P13 were similar to that of the innovator infliximab. These findings, they say, hold promise for wider switching to cost-saving biosimilars.

Spanish Data Find Good Safety and Efficacy 2 Years After Switching

Researchers from Spain will report similarly positive findings from a switch to CT-P13.² In a prospective, single-center observational study in 100 patients with IBD, all patients switched from the reference infliximab to CT-P13 and were followed up to 24 months.

At 24 months, 72% of patients remained on the biosimilar, 15% had discontinued due to loss of response, 4% discontinued due to AEs, and 8% discontinued due to remission or mucosal healing.

At months 6, 12, 18, and 24, the respective rates of remission were 75.8%, 69.6%, 69.9%, and 68.5%. In total, 22% of patients had a dose escalation.

Serious AEs were reported in 14% of patients, and 2 patients developed anti-drug antibodies (ADAs).

According to the authors, these data demonstrate that, at 2 years, CT-P13 maintained good effectiveness and safety profiles, and most patients continued treatment.

Irish Researchers Find No Change in Clinical Remission Post-Switch

Researchers from 2 tertiary Irish hospitals will report on an open-label, prospective cohort study that involved 74 patients with IBD, all of whom switched to CT-P13 between 2017 and 2018.³

Data were collected at 3-month intervals starting 6 months prior to the switch, and no significant difference was found in CRP levels before and after the switch. There was also no difference observed in infliximab levels pre- and post-switch, and no new clinically significant ADAs were detected.

The researchers report that the switch also produced a significant cost savings for the 2 centers studied, with the biosimilar allowing for a cost reduction of up to 69% versus the reference product.

French Study Reports that Patient Education Plays a Role in Switch Acceptance

Finally, French researchers will report that patient education has a positive impact on a switch’s success.⁴

In a single center, 86 patients with IBD, all of whom had been in clinical remission for 6 months or more, completed a questionnaire on their knowledge of biosimilars and their acceptance of a switch. Patients had a choice as to whether to accept the switch.

At baseline, 77% of patients had never heard of a biosimilar, but 85% were in favor of a switch, though 61% expressed some concerns.

Initially, 47% of patients refused the switch, but 78% of that subgroup agreed to additional education from a nurse. Eventually, 68% of the subgroup accepted the switch.

At week 16, among patients who switched, persistence on the biosimilar was 91%. No new ADAs were detected after the switch.

At week 16, 84% of patients said they knew about biosimilars, 93% were in favor of the switch, and 39% expressed concerns.

These findings demonstrate, write the authors, that not only is a switch to CT-P13 safe, but also that education plays a key role patient acceptance.

References

1. Bhandare AP, Crooks B, Nigam GB, Limdi JK. Switching from originator infliximab to CT-P13: single-center experience from the UK. Presented at the 14th Congress of the European Crohn’s and Colitis Organisation; March 6-9, 2019; Copenhagen, Denmark. Abstract P337. ecco-ibd.eu/publications/congress-abstract-s/item/p337-switching-from-originator-infliximab-to-ct-p13-single-centre-experience-from-the-uk.html.

2. Guerra Veloz M, Belvis Jimenez M, Valdes Delgado T, et al. Long-term follow-up of switching from original infliximab to infliximab biosimilar: real-world data. Presented at the 14th Congress of the European Crohn’s and Colitis Organisation; March 6-9, 2019; Copenhagen, Denmark. Abstract P335. ecco-ibd.eu/publications/congress-abstract-s/item/p335-long-term-follow-up-of-switching-from-original-infliximab-to-infliximab-biosimilar-real-world-data.html.

3. McGettigan N, Mc Shane C, Mc Carthy O, Keogh A, Devans D, Slattery E. A prospective study of planned switch from infliximab originator remicade to biosimilar inflectra: a multi-center Irish experience. Presented at the 14th Congress of the European Crohn’s and Colitis Organisation; March 6-9, 2019; Copenhagen, Denmark. Abstract P725. ecco-ibd.eu/publications/congress-abstract-s/item/p725-a-prospective-study-of-planned-switch-from-infliximab-originator-remicade-to-biosimilar-inflectra-a-multi-centre-irish-experience.html.

4. Hastier-De Chelle A, Cluzeau V, Condat J, Arab N, Hébuterne X, Filippi J. Impact of patient education on switch acceptance in IBD patients in remission, with infliximab originator switched for an infliximab biosimilar: a prospective study. Presented at the 14th Congress of the European Crohn’s and Colitis Organisation; March 6-9, 2019; Copenhagen, Denmark. Abstract P544. ecco-ibd.eu/publications/congress-abstract-s/item/p544-impact-of-patient-education-on-switch-acceptance-in-ibd-patients-in-remission-with-infliximab-originator-switched-for-an-infliximab-biosimilar-a-prospective-study.html.