4 Studies Highlight Biosimilar Switching's Effect on Patients With IBD

At the European Crohn’s and Colitis Organisation’s 13th annual congress, held in Vienna, Austria, a number of studies explored switching from reference infliximab to its biosimilar.

Multiple Switches of Reference and Biosimilar Infliximab

A study¹ on a reverse switch from biosimilar infliximab to reference infliximab in 117 patients with inflammatory bowel disease (IBD) in Hungary found that all but 1 patient tolerated the first infusion after the switch.

Previously, biosimilar infliximab was mandated for all Hungarian infliximab-naïve patients and for exposed patients with at least a 1-year drug holiday. The switch back to the reference product took place after a change in the nation’s health system policy and was mandatory for all patients, which provided an opportunity to study the short-term drug sustainability, safety, and immunogenicity profile of a reversed switch in a consecutive, multicenter, real-life cohort.

Only 1 patient did not tolerate the first infusion; that patient experienced an infusion-related reaction. Follow-up and therapeutic drug monitoring measurements are in progress.

Switching to Biosimilar CT-P13 Did Not Affect Quality of Life

An open-label, noninferiority, multicenter study² in patients who were in stable remission from IBD sought to demonstrate that patients’ quality of life is noninferior after switching from originator infliximab to CT-P13 (and to demonstrate that the efficacy and safety of CT-P13 is non-inferior to that of the reference in patients with IBD). Quality of life was assessed by IBD questionnaire (IBDQ) measurements at baseline and after 2 and 6 infusions of the biosimilar.

In total, 119 patients participated (42 patients had ulcerative colitis [UC]; 77 patients had Crohn disease [CD]). The mean (± standard error of the mean) changes in IBDQ after 2 infusions and 6 infusions compared with originator were, respectively, −0.6 (±4.4) and −5.4 (±4.3) for the UC group and −2.7 ± 2.5 and −1.0 (± 5.5) for the CD group. There was no significant difference in clinical efficacy between the 2 drugs.

“[Quality of life] and clinical efficacy did not significantly change for IBD patients in stable remission switched from the originator infliximab to CT-P13 in daily clinical practice,” say the researchers.

Communicating With Patients Is Key

A 2016 French study³ surveyed 76 patients with IBD (as well as 25 patients with rheumatic diseases and 5 patients with other diseases) in order to gather patient perspectives on switching to a biosimilar infliximab from its reference. Semi-structured interviews were conducted on using an interview guide.

Of the patients, 61% were in favor of generics, but 86.8% had never heard of biosimilars. Only 56.6% of patients would agree to switch to the biosimilar infliximab (these patients mainly agreed to switch on the basis of equivalent safety and tolerability of the biosimilar), while 27.6% refused (mainly because they had confidence in their existing treatment and believed that a switch would be ineffective), and 15.8% felt unsure and reported that they would need to be convinced to switch by a specialist. These responses were mirrored, say the researchers, by those of the patients with rheumatic and other diseases.

“These results show the need for communication with patients about the concept of biosimilars,” concluded the researchers, who added that “A discussion with the patient…seems necessary to reduce the ‘nocebo effect.’”

Even After Switching, Some Patients Remain Concerned

In a prospective, observational, monocentric French study⁴ in 117 patients whose IBD was in clinical remission for at least 6 months, researchers provided each patient with individualized information about biosimilars and the possibility of switching from reference infliximab to CT-P13.

Between June 2015 and December 2015, 113 of the patients (97%) consented to the switch. During the follow-up period, 14 (12.4%) experienced a loss of response. Among these patients, 11 later regained clinical remission after dose optimization, 1 experienced an infusion reaction, 1 chose to switch back to the reference drug and regained clinical remission, and 1 did not did not respond to dose optimization. Eight patients discontinued therapy after achieving deep remission.

A significant improvement in fatigue was demonstrated in those who switched (as measured by Functional Assessment of Chronic Illness Therapy-Fatigue scale) and there was no difference in patient perspective as measured by Beliefs about Medicines Questionnaire. Despite these findings, an additional questionnaire showed that patients were still concerned about the possibility of their therapy being switched, especially the possibility of being switched according to a pharmacist’s decision.

“These latter concerns did not change after switching,” say the authors.

References

1. Ilias A, Szanto K, Gonczi L, et al. Non-medical mandatory reversed back and forth switch between infliximab and its biosimilars: early clinical outcomes. Presented at the 13th Congress of the European Crohn’s and Colitis Organisation, February 14 to 17, 2018; Vienna, Austria. Abstract P694. https://www.ecco-ibd.eu/publications/congress-abstract-s/abstracts-2018/item/p694-non-medical-mandatory-reversed-and-back-and-forth-switch-between-infliximab-and-its-biosimilar-early-clinical-outcomes.html.

2. Pierik MJ, van der Meulen-de Jong AE, Bloemsaat-Minekus JPJ, van Megen YJB, Dijkstra G. Switching from the originator infliximab to biosimilar CT-P13 did not change the quality of life and clinical efficacy for IBD patients in stable remission in daily clinical practice (interim analysis). Presented at the 13th Congress of the European Crohn’s and Colitis Organisation, February 14 to 17, 2018; Vienna, Austria. Abstract P464. https://www.ecco-ibd.eu/publications/congress-abstract-s/abstracts-2018/item/p464-switching-from-the-originator-infliximab-to-biosimilar-ct-p13-did-not-change-the-quality-of-life-and-clinical-efficacy-for-ibd-patients-in-stable-remission-in-daily-clinical-practice-interim-analysis.html.

3. Baudrant M, Roche A, Allenet B, et al. Interchangability by a biosimilar of infliximab: what do patients think? Presented at the 13th Congress of the European Crohn’s and Colitis Organisation, February 14 to 17, 2018; Vienna, Austria. Abstract P780. https://www.ecco-ibd.eu/publications/congress-abstract-s/abstracts-2018/item/p780-interchangeability-by-a-biosimilar-of-infliximab-what-do-patients-think.html.

4. Petitdidier N, Gagniere C, Rentien AL, et al. Patients’ perspectives on switching from reference infliximab to CT-P13 biosimilar in patients with inflammatory bowel disease: a 12-month prospective observational cohort study. Presented at the 13th Congress of the European Crohn’s and Colitis Organisation, February 14 to 17, 2018; Vienna, Austria. Abstract P528. https://www.ecco-ibd.eu/publications/congress-abstract-s/abstracts-2018/item/p528-patients-x2019-perspectives-on-switching-from-reference-infliximab-to-ct-p13-biosimilar-in-patients-with-inflammatory-bowel-disease-a-12-month-prospective-observational-cohort-study.html.