Serum concentrations after switching from originator infliximab to the biosimilar CT-P13 in patients with quiescent inflammatory bowel disease (SECURE): an open-label, multicentre, phase 4 non-inferiority trial

Strik, Anne S.; Vrie, Wim van de; Bloemsaat-Minekus, Joanne P J; Nurmohamed, Michael T.; Bossuyt, Peter; Bodelier, Alexander; Rispens, Theo; Megen, Y.J.B. van; D’Haens, Geert R.

doi:10.1016/s2468-1253(18)30082-7

Cited by 62 publications

(45 citation statements)

References 17 publications

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“…Awareness is required especially in the interpretation of subjective health complaints by the patient. Indeed, open‐label observational studies examining outcomes after switching from a biologic originator to a biosimilar showed no difference in objective disease markers such as infliximab drug levels, C‐reactive protein levels and fecal calprotectin levels, but could mark some differences regarding subjective disease features …”

Section: Discussionmentioning

confidence: 99%

Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients

Pouillon

Danese

Hart

et al. 2019

Aliment Pharmacol Ther

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Background:The nocebo effect is a negative effect of a pharmacological or nonpharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes.Aim: To develop evidence-based consensus recommendations for the prevention and management of the nocebo effect in biosimilar-treated patients with IBD. Methods:The "NOCE-BIO Consensus Group" was composed of 19 members from five European countries, and with different fields of expertise. A literature review on the nocebo effect, with specific focus on information about its prevention and management in biosimilar-treated IBD patients, was performed. Preliminary statements were formulated and voted on during a consensus group meeting held in Milan, Italy, in July 2018. A statement was accepted if >75% of participants voted 4 ("agree") or 5 ("strongly agree") on a scale of 1-5.Results: Consensus was reached on 11 recommendation statements. Seven statements reached consensus after one voting round and four statements reached consensus after two voting rounds. All statements were supported by very low-quality level of evidence.The panel agreed that patient-health-care provider relationship is a key driver of acceptance of biosimilars, which limits the risk of negative bias and the nocebo effect. Lack of knowledge among patients and health-care providers about the effectiveness and safety of biosimilars should be minimized. Education about biosimilars needs to be tailored to the individual patient, and positive framing is recommended. Conclusions:The nocebo effect is under-recognised in the era of biosimilars, although it may negatively impact on the cost-savings of biosimilars. Future research should focus on the magnitude, the risk factors, the impact, and the management of the nocebo effect in biosimilars-treated IBD patients.

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Section: Discussionmentioning

confidence: 99%

Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients

Pouillon

Danese

Hart

et al. 2019

Aliment Pharmacol Ther

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“…In line with these observations, other clinical trials demonstrated similar efficacy, safety, and immunogenicity outcomes . Nowadays, switching patients from Remicade ® to CT‐P13 has become part of routine care in most European countries since evidence about switching is reassuring . Although IFX is an effective therapeutic agent for inducing and maintaining remission in IBD patients, side effects are relatively frequently observed.…”

Section: Introductionmentioning

confidence: 58%

“…Controlled clinical trials are needed in order to investigate the consequences of switching patients from Remicade ® to CT‐P13 with regard to both efficacy and safety. The SECURE trial, a multicenter clinical trial performed in the Netherlands and Belgium, investigated pharmacokinetics in patients with quiescent IBD receiving IFX maintenance treatment before and after switching from Remicade ® to CT‐P13 . In this noninferiority trial, no differences were observed in IFX serum concentrations at trough after switching to CT‐P13.…”

Section: Introductionmentioning

confidence: 99%

Hemolytic anemia after switching from infliximab originator to biosimilar CT‐P13 in a patient with inflammatory bowel disease: A case report

Strik

D’Haens

Löwenberg

2019

Clinical Case Reports

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“…Due to the significant inter-study heterogeneity of the patient populations, baseline characteristics, dosing schedules, and follow-up periods, a meaningful comparison between the published observational switch studies becomes difficult to conduct and interpret. For example, 6 out of 21 published observational studies (Table 3) reported a loss of effectiveness over the study period for both CD and UC patient populations, with values ranging from 6.3 to 30.2% and 0 to 22%, respectively [15][16][17][18][19][20]. Five studies reported a loss of response for IBD switch groups as a whole, varying from 0 to 24.6% [21][22][23][24][25].…”

Section: Evidence From Published Observational Switch Studiesmentioning

confidence: 99%

Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease

2020

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Background and Aims Biosimilar approval, such as Inflectra™ (CT-P13) for treating ulcerative colitis (UC) and Crohn's disease (CD), has reduced direct drug costs. Though clinicians are comfortable with biosimilar use in treatment-naïve patients, there are concerns in some jurisdictions that there are insufficient data from well-controlled trials to support non-medical switching. A systematic review, along with a critical assessment of the study design, was conducted to assess the potential impact of switching stable CD/UC patients from infliximab to CT-P13. Methods A literature search using PubMed and abstracts/posters from 3 major gastroenterology conferences from 2014 to 2018 was completed. Two individual reviewers extracted data from each relevant report and compiled it into evidence tables to facilitate descriptive analyses. Key randomized trial and observational study designs were critically assessed to contextualize data relevance. Results A total of 49 reports (3 randomized controlled trials, 40 observational trials, and 1 case series) were included. Most studies revealed no efficacy, safety, or immunogenicity concerns with non-medical switch. Limitations of supporting data include a small number of randomized controlled trials; predominance of observational studies with varying outcome assessments and lack of appropriate controls; and scarcity of research on biosimilar switch long-term effects. Conclusions The majority of studies suggested non-medical switch is safe. However, clinicians and regulatory bodies should be aware of differences and limitations in study designs when making inferences about the risks and benefits of switching stable IBD patients to biosimilars.

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Serum concentrations after switching from originator infliximab to the biosimilar CT-P13 in patients with quiescent inflammatory bowel disease (SECURE): an open-label, multicentre, phase 4 non-inferiority trial

Cited by 62 publications

References 17 publications

Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients

Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients

Hemolytic anemia after switching from infliximab originator to biosimilar CT‐P13 in a patient with inflammatory bowel disease: A case report

Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease

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