Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort

Gecse, Krisztina; Lovász, Barbara D.; Farkas, Klaudia; Banai, János; Bene, László; Gasztonyi, Beáta; Golovics, Petra A.; Kristóf, Tünde; Lakatos, László; Csontos, Á; Juhász, Márk; Nagy, Ferenc; Palatka, Károly; Papp, Mária; Patai, Árpád V.; Lakner, Lilla; Salamon, Ágnes; Szamosi, Tamás; Szepes, Zoltán; Tóth, Gábor; Vincze, Áron; Szalay, Balázs; Molnár, Tamás; Lakatos, Péter L.

doi:10.1093/ecco-jcc/jjv220

Cited by 175 publications

(144 citation statements)

References 30 publications

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“…However, patients with previous infliximab exposure exhibited lower response rates and were more likely to develop allergic reactions [106].…”

Section: Biosimilars In Ibdmentioning

confidence: 99%

“…Multiple studies have shown that CT-P13 appears to have comparable efficacy and safety for patients requiring induction therapy and maintenance of remission in IBD [105,106]. 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: 99%

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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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“…However, patients with previous infliximab exposure exhibited lower response rates and were more likely to develop allergic reactions [106].…”

Section: Biosimilars In Ibdmentioning

confidence: 99%

Section: Biosimilars In Ibdmentioning

confidence: 99%

Emerging biologics in inflammatory bowel disease

Chan

2016

J Gastroenterol

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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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“…Indeed, these studies could elucidate the controversial points regarding the efficacy and safety of the long-term use of this biosimilar drug (4) . A small number of cases of IBD patients treated with CT-P13 have been published to date (5,7,8,(10)(11)(12)17,21) . Moreover, it is also known that there is still no prospective head-to-head or non-inferiority randomized studies comparing CT-P13 with the reference IFX.…”

Section: Dear Sirmentioning

confidence: 99%

Anvisa Approves the First Biosimilar Monoclonal Antibody Based on Comparability in Brazil

Teixeira¹,

Kotze²,

Damião³

2016

Arq. Gastroenterol.

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Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort

Abstract: This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions.

Cited by 175 publications

References 30 publications

Emerging biologics in inflammatory bowel disease

Emerging biologics in inflammatory bowel disease

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

Anvisa Approves the First Biosimilar Monoclonal Antibody Based on Comparability in Brazil

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