Induction Therapy With Biosimilar Infliximab in Children With Crohn Disease

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

doi:10.1097/mpg.0000000000001643

Cited by 30 publications

(37 citation statements)

References 27 publications

(30 reference statements)

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“…They reported one acute infusion reaction, but no unexpected adverse events. 13 A prospective study on paediatric patients introduced to CT-P13 showed a decline in median calprotectin levels from 840 to 250 μg/g in 17 patients at week 12 (P = .008) (14). Our study observed therapeutic responses in 90% of the patients during F I G U R E 1 Proportion of anti-tumour necrosis factor α-naïve paediatric patients with IBD on maintenance therapy with infliximab or its biosimilar.…”

Section: Discussionmentioning

confidence: 58%

“…The following year, the same authors reported outcomes to induction therapy with CT-P13 in 36 patients with paediatric IBD, with assessments performed before the infusion and at week 14. 13 When they used the Paediatric Crohn's Disease Activity Index, they observed a clinical response in 86% and clinical remission in 67% of the patients. Faecal calprotectin levels or trough level measurements were not available.…”

Section: Discussionmentioning

confidence: 99%

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Infliximab and its biosimilar produced similar first‐year therapy outcomes in patients with inflammatory bowel disease

Nikkonen

Kolho

2019

Acta Paediatrica

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Aim Tumour necrosis factor α inhibitors (anti‐TNFα) are the main therapy for moderate to severe inflammatory bowel disease (IBD) in children. Biosimilars to the original drug infliximab are now available, but there are few reports on their real‐life use. We compared the outcomes of patients treated with infliximab and its biosimilar, CT‐P13. Methods We collected outcome data on anti‐TNFα‐naive patients who started infliximab in the Children's Hospital, University of Helsinki, Finland, in 2015‐2016. We studied 51 paediatric patients with IBD at a median age of 12 (range 4‐16): 65% had Crohn disease, 23 received the original infliximab drug and 28 received the biosimilar. During 2015, infliximab was introduced to all treatment‐naïve patients, and during 2016, all treatment‐naïve patients received the biosimilar. Results We found no statistically significant differences between the two drug products related to the outcome of the therapy during the first year. There were no significant differences in the trough levels between the treatment groups. Likewise, the proportion of patients with therapy enhancement was comparable between the two treatment groups. Conclusion The first‐year therapy outcomes of infliximab and its biosimilar were comparable. There were no alarming signs of differences in safety.

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Section: Discussionmentioning

confidence: 58%

Section: Discussionmentioning

confidence: 99%

Infliximab and its biosimilar produced similar first‐year therapy outcomes in patients with inflammatory bowel disease

Nikkonen

Kolho

2019

Acta Paediatrica

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“…In the Norwegian study by Jahnsen et al, infusion reaction occurred in 1 CD and 1 UC patients, rate of adverse event was 2.2% and 3.1% in CD and UC [40]. The studies from Poland revealed that safety profile is similar to that reported for the reference IFX and adverse event rate did not differ significantly either in CD or in UC before and after the switch from IFX to CT-P13 [38,44]. The Hungarian multicenter study revealed adverse events in 17.1% of all patients.…”

Section: Safety and Tolerabilitymentioning

confidence: 77%

A Review on Biosimilar Infliximab, CT-P13, in the Treatment of Inflammatory Bowel Disease

Farkas

Molnár

2017

Immunotherapy

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The introduction of biological agents has led to significant changes in the treatment of inflammatory bowel disease (IBD). The relatively high price of infliximab (IFX) and the expiration of the patents led to the introduction of biosimilar agents. CT-P13 was the first IFX biosimilar approved in the same indications as the reference product; however, the approval was based on randomized clinical trials conducted in patients with rheumatoid arthritis and ankylosing spondylitis. In the past 2-3 years, new findings from prospective observational studies supported the short-, medium- and long-term clinical efficacy and safety of CT-P13 in patients with IBD. This review summarized the clinical use and efficacy of the first biosimilar IFX, CT-P13, in the treatment of IBD.

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“…A study of 96 patients comparing the efficacy of infliximab compared to biosimilar CT-P13 in maintaining remission in inflammatory bowel diseases found similar long-term outcomes and safety between the two treatment groups[ 10 ]. Additionally, a study on CT-P13 in pediatric Crohn’s disease reported remission after three doses in 24 of 36 patients and clinical response in 31 of 36[ 11 ]. CT-P13 is currently marketed as Remsima™ and Inflectra™.…”

Section: Inflammatory Bowel Diseasesmentioning

confidence: 99%

Biosimilars: Review of current applications, obstacles, and their future in medicine

Kaida-Yip

Deshpande

Saran

et al. 2018

WJCC

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Biosimilars are a growing drug class designed to be used interchangeably with biologics. Biologics are created in living cells and are typically large, complex proteins that may have a variety of uses. Within the field of gastroenterology alone, biologics are used to treat inflammatory bowel diseases, cancers, and endocrine disorders. While biologics have proven to be effective in treating or managing many diseases, patient access is often limited by high costs. The development of biosimilars is an attempt to reduce treatment costs. Biosimilars must be nearly identical to their reference biologics in terms of efficacy, side effect risk profile, and immunogenicity. Although the manufacturing process still involves production within living cells, biosimilars undergo fewer clinical trials than do their reference biologics. This ultimately reduces the cost of production and the cost of the biosimilar drug compared to its reference biologic. Currently, seven biosimilars have been approved by the United States Food and Drug Administration (FDA) for use in Crohn’s disease, ulcerative colitis, and colorectal cancer. There are other biologics involved in treating gastroenterologic diseases for which there are no FDA approved biosimilars. Although biosimilars have the potential to reduce healthcare costs in chronic disease management, they face challenges in establishing a significant market share. Physician comfort in prescribing reference biologics instead of biosimilars and patient reluctance to switch from a biologic to a biosimilar are two common contributing factors to biosimilars’ slow increase in use. More time will be needed for biosimilars to establish a larger and more consistent market share compared to their reference biologics. Additional data confirming the safety and efficacy of biosimilars, increased number of available biosimilars, and further cost reduction of biosimilars will all be necessary to improve physician confidence in biosimilars and patient comfort with biosimilars.

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Induction Therapy With Biosimilar Infliximab in Children With Crohn Disease

Abstract: Induction therapy with CT-P13 in children with CD is effective. The profile appears similar to that reported for the reference infliximab. No unexpected adverse events occurred.

Cited by 30 publications

References 27 publications

Infliximab and its biosimilar produced similar first‐year therapy outcomes in patients with inflammatory bowel disease

Infliximab and its biosimilar produced similar first‐year therapy outcomes in patients with inflammatory bowel disease

A Review on Biosimilar Infliximab, CT-P13, in the Treatment of Inflammatory Bowel Disease

Biosimilars: Review of current applications, obstacles, and their future in medicine

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