Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris, France

Avouac, Jérôme; Moltó, Anna; Abitbol, Véred; Etcheto, Adrien; Salcion, Axelle; Gutermann, Loriane; Klotz, C.; Elhaï, Muriel; Cohen, Pascal; Soret, Pierre Antoine; Morin, Florence; Conort, O.; Chast, François; Goulvestre, Claire; Jeunne, Claire Le; Chaussade, Stanislas; Kahan, André; Roux, Christian; Allanore, Yannick; Dougados, Maxime

doi:10.1016/j.semarthrit.2017.10.002

Cited by 66 publications

(64 citation statements)

References 23 publications

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“…The rate of acceptance of SB4 in this study was higher than that reported previously for CT‐P13 in our first transitioning study (the BIO‐SWITCH study, with an acceptance rate of 88%) . The rate of SB4 treatment persistence was also higher than that in previously published studies on non‐mandatory transitioning from REM to CT‐P13 (persistence rates varying from 76% at month 6 , 74% at week 34 , and 72% at month 12 ). We hypothesize that the higher rates of acceptance and treatment persistence of SB4 could be attributed to the implementation of the structured communication strategy prior to the initiation of the transition to SB4.…”

Section: Discussioncontrasting

confidence: 80%

“…In light of shared treatment decision‐making between patients and physicians, non‐mandatory transitioning might be a preferable approach over mandatory transitioning. First attempts with non‐mandatory transitioning have, unfortunately, shown suboptimal rates of CT‐P13 acceptance and persistence in 4 different cohort studies , with discontinuation of CT‐P13 being driven mainly by patients’ subjective health complaints .…”

mentioning

confidence: 99%

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Open‐Label, Non‐Mandatory Transitioning From Originator Etanercept to Biosimilar SB4

Tweehuysen

Huiskes

Bemt

et al. 2018

Arthritis & Rheumatology

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Section: Discussioncontrasting

confidence: 80%

mentioning

confidence: 99%

Open‐Label, Non‐Mandatory Transitioning From Originator Etanercept to Biosimilar SB4

Tweehuysen

Huiskes

Bemt

et al. 2018

Arthritis & Rheumatology

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“…Other, indirect, evidence about the impact of the nocebo effect in biosimilar‐treated patients was extracted from open‐label observational switching studies. Again, the majority of this indirect evidence was extrapolated from studies conducted in patients with rheumatic diseases, however two studies also included IBD patients . There were no data about the etiology and risk factors of the nocebo effect in biosimilar‐treated IBD patients, however one systematic review summarised contributing factors to the nocebo effect across other indications …”

Section: Methodsmentioning

confidence: 99%

“…This high drop‐out rate was mainly due to subjective disease features and adverse events, suggesting that incorrect attribution and/or the nocebo effect were the main drivers . Other open‐label observational studies confirmed that treatment persistence after switching to a biosimilar was negatively influenced by mainly subjective health complaints and patient‐reported outcomes, also hinting towards a role of the nocebo effect …”

Section: Introductionmentioning

confidence: 90%

“…It has been recognised as an important clinical challenge in the current era of biosimilars, since it can lower patients' quality of life and negatively affect treatment adherence rates . Evidence that the nocebo effect might indeed lead to unnecessary cessation of biologic treatment is mainly indirectly derived from open‐label observational studies, because double‐blinded trials are less susceptible to the nocebo effect . In the BIO‐SWITCH study, 192 patients with rheumatoid arthritis (RA), psoriatic arthritis or ankylosing spondylitis (AS) were observed after transition from infliximab originator to infliximab biosimilar CT‐P13 .…”

Section: Introductionmentioning

confidence: 99%

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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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The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review

Barbier

Ebbers

Declerck

et al. 2020

Clin Pharma and Therapeutics

110

102

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To date, no consensus exists among stakeholders about switching patients between reference biological products (RPs) and biosimilars, which may have been curbing the implementation of biosimilars in clinical practice. This study synthesizes the available data on switching and assesses whether switching patients from a RP to its biosimilar or vice versa affects efficacy, safety, or immunogenicity outcomes. A total of 178 studies, in which switch outcomes from a RP to a biosimilar were reported, was identified. Data were derived from both randomized controlled trials and real‐world evidence. Despite the limitations stemming from a lack of a robust design for most of the studies, the available switching data do not indicate that switching from a RP to a biosimilar is associated with any major efficacy, safety, or immunogenicity issues. Some open‐label and observational studies reported increased discontinuation rates after switching, which were mainly attributed to nocebo effects. Involvement of the prescriber in any decision to switch should remain and attention should be paid to the mitigation of a potential nocebo effect.

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Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris, France

Cited by 66 publications

References 23 publications

Open‐Label, Non‐Mandatory Transitioning From Originator Etanercept to Biosimilar SB4

Open‐Label, Non‐Mandatory Transitioning From Originator Etanercept to Biosimilar SB4

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

The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review

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