Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations

Sieczkowska, Joanna; Jarzębicka, Dorota; Banaszkiewicz, Aleksandra; Plocek, Anna; Gawrońska, Agnieszka; Toporowska-Kowalska, Ewa; Oracz, Grzegorz; Meglicka, Monika; Kierkuś, Jarosław

doi:10.1093/ecco-jcc/jjv233

Cited by 117 publications

(102 citation statements)

References 14 publications

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“…9,10 About 50% of patients with psoriasis who start infliximab have to discontinue treatment within the first year because of loss of efficacy attributed to antiinfliximab antibodies and a faster drug clearance.…”

Section: Cohort 1: Patients With Psoriasis Who Switched From the Inflmentioning

confidence: 99%

The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis

Dapavo

Vujic

Fierro

et al. 2016

Journal of the American Academy of Dermatology

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Section: Cohort 1: Patients With Psoriasis Who Switched From the Inflmentioning

confidence: 99%

The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis

Dapavo

Vujic

Fierro

et al. 2016

Journal of the American Academy of Dermatology

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“…Switching from the infliximab originator to its biosimilar was also shown to be safe in pediatric CD patients, and appeared to be as effective as the originator [107,108].…”

Section: Biosimilars In Ibdmentioning

confidence: 97%

Emerging biologics in inflammatory bowel disease

Chan

2016

J Gastroenterol

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Early biologic therapy is recommended in patients with inflammatory bowel disease and poor prognostic factors and in those refractory to conventional medications. Anti-tumor necrosis factor (anti-TNF) agents are the most commonly used biologic agents. However, some patients may not have an initial response to anti-TNF therapy, and one-third will develop loss of response over time. Anti-TNF drugs can also be associated with side effects. In addition, the use of biologics is currently limited by their cost, especially in developing countries. A number of new therapeutic targets, including novel small molecules, and cellular therapy are available or under investigation. These novel molecules include oral Janus kinase (JAK) inhibitor (tofacitinib), interleukin inhibitor (ustekinumab), oral SMAD7 antisense oligonucleotide (mongersen), and anti-integrin inhibitors (vedolizumab). Here, we review the mechanisms of action, the efficacy, and the safety data of these novel agents. Biological products that are highly similar to reference biologic products whose patents have expired-also known as ''biosimilars''-can be produced at lower cost with similar efficacy, and are also available for the treatment of IBD. We review the efficacy data for such agents as well.

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“…Nevertheless, there is no evidence to support true interchangeability, which requires the safe and tolerable switch from originator to biosimilar and back again. Recent studies of infliximab biosimilars indicated efficacy and safety similar to the infliximab originator [95][96][97]. Importantly, antibodies to infliximab also recognize biosimilar infliximab [98].…”

Section: Future Directions Inflammatory Bowel Diseasementioning

confidence: 99%

The Impact of Therapeutic Antibodies on the Management of Digestive Diseases: History, Current Practice, and Future Directions

Sofia

Rubin

2017

Dig Dis Sci

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The development of therapeutic antibodies represents a revolutionary change in medical therapy for digestive diseases. Beginning with the initial studies that confirmed the pathogenicity of cytokines in inflammatory bowel disease, the development and application of therapeutic antibodies brought challenges and insights into their potential and optimal use. Infliximab was the first biological drug approved for use in Crohn's disease and ulcerative colitis. The lessons learned from infliximab include the importance of immunogenicity and the influence of pharmacokinetics on disease response and outcomes. Building on this foundation, other therapeutic antibodies achieved approval for inflammatory bowel disease and many more are in development for several digestive diseases. In this review, we reflect on the history of therapeutic antibodies and discuss current practice and future directions for the field.

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Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations

Abstract: Switching from infliximab originator to its biosimilar seems to be a safe option in children with CD. After the switch the biosimilar was just as effective as the originator.

Cited by 117 publications

References 14 publications

The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis

The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis

Emerging biologics in inflammatory bowel disease

The Impact of Therapeutic Antibodies on the Management of Digestive Diseases: History, Current Practice, and Future Directions

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