Similar Growth Outcomes in Children with Inflammatory Bowel Disease Initiated on Infliximab Originator or Biosimilar

McClinchie, Madeline G; Lakhani, Alyshah; Abdel‐Rasoul, Mahmoud; McNicol, Megan; Shaikhkhalil, Ala; Boyle, Brendan M.; Maltz, Ross

doi:10.1097/mpg.0000000000003890

Cited by 3 publications

(1 citation statement)

References 35 publications

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“…Recently, favourable clinical data have been published on the efficacy of CT-P13 in pediatric IBD ( 15 , 17 , 21 – 25 ). However, these studies have not compared long-term clinical efficacy based on EH and durability between the IFX originator and CT-P13 in pediatric IBD.…”

Section: Introductionmentioning

confidence: 99%

Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease

Kim,

Choi,

Choe

et al. 2024

Front. Immunol.

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Background and aimsFavourable clinical data were published on the efficacy of CT-P13, the first biosimilar of infliximab (IFX), in pediatric inflammatory bowel disease (IBD); however, few studies have compared the effect on endoscopic healing (EH) and drug retention rate between the IFX originator and CT-P13. Therefore, we aimed to compare EH and the drug retention rate between the IFX originator and CT-P13.MethodsChildren with Crohn’s disease (CD) and ulcerative colitis (UC)/IBD-unclassified (IBD-U) at 22 medical centers were enrolled, with a retrospective review conducted at 1-year and last follow-up. Clinical remission, EH and drug retention rate were evaluated.ResultsWe studied 416 pediatric patients with IBD: 77.4% had CD and 22.6% had UC/IBD-U. Among them, 255 (61.3%) received the IFX originator and 161 (38.7%) received CT-P13. No statistically significant differences were found between the IFX originator and CT-P13 in terms of corticosteroid-free remission and adverse events. At 1-year follow-up, EH rates were comparable between them (CD: P=0.902, UC: P=0.860). The estimated cumulative cessation rates were not significantly different between the two groups. In patients with CD, the drug retention rates were 66.1% in the IFX originator and 71.6% in the CT-P13 group at the maximum follow-up period (P >0.05). In patients with UC, the drug retention rates were 49.8% in the IFX originator and 56.3% in the CT-P13 group at the maximum follow-up period (P >0.05).ConclusionsThe IFX originator and CT-P13 demonstrated comparable therapeutic response including EH, clinical remission, drug retention rate and safety in pediatric IBD.

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Section: Introductionmentioning

confidence: 99%

Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease

Kim,

Choi,

Choe

et al. 2024

Front. Immunol.

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Change from originator infliximab to biosimilar does not affect 1‐year outcome in children with inflammatory bowel disease

Solomon,

Kuzoian,

Michel

et al. 2024

JPGN rep.

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ObjectivesPayer mandates have resulted in children with inflammatory bowel disease (IBD) switching from originator Remicade® (O‐Rem) to an infliximab biosimilar (B‐IFX). Patients and families are fearful of switching because disease has been well controlled on O‐Rem. Real‐world data documenting clinical outcomes after such switches in pediatric patients are limited. The aim of this project was to examine 1 year of follow‐up in a large adolescent/young adult IBD cohort who changed from O‐Rem to B‐IFX.MethodsWe identified patients with IBD at Connecticut Children's receiving O‐Rem for at least 1 year, who were either in clinical remission or had low disease activity, and who were subsequently switched to B‐IFX. An age, gender, IBD‐subtype, and duration since diagnosis cohort that continued on O‐Rem was then matched to the switch cohort and served as a comparator group (1: switch vs. 2: no‐switch). B‐IFX was Inflectra® in all cases.ResultsTwo hundred seventy‐nine patients (mean age 18.7 years, Crohn's disease = 243, ulcerative colitis = 36) were studied (switch, n = 93, no‐switch, n = 186). Mean time since diagnosis was >6 years in both groups, and mean duration of anti‐tumor necrosis factor use was >5 years. There were no significant changes in hemoglobin, albumin, C‐reactive protein, erythrocyte sedimentation rate, or disease activity in either group over 1 year. Dosing modifications as well as the frequency of low‐level antibodies to infliximab were similar in both groups over the study period.ConclusionSwitching from O‐Rem to B‐IFX has no impact on clinical or laboratory parameters over the subsequent year. Clinicians can reliably reassure patients and families that switching is safe.

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Improved Clinical Outcomes With Early Anti-Tumour Necrosis Factor Alpha Therapy in Children With Newly Diagnosed Crohn’s Disease: Real-world Data from the International Prospective PIBD-SETQuality Inception Cohort Study

Klomberg,

van der Wal,

Aardoom

et al. 2023

Journal of Crohn's and Colitis

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Background and Aims Treatment guidelines for paediatric Crohn’s disease [CD] suggest early use of anti-tumour necrosis factor alpha [anti-TNFα] in high-risk individuals. The aim is to evaluate the effect of early anti-TNF in a real-world cohort. Methods Children with newly diagnosed CD were prospectively recruited at 28 participating sites of the international observational PIBD-SETQuality study. Outcomes were compared at 3 months, 1 and 2 years between patients receiving early anti-TNF [<90 days after diagnosis] and those not receiving early anti-TNF. Outcomes included sustained steroid-free remission [SSFR] without treatment intensification [specified as SSFR*] and sustained steroid-free mild/inactive disease without treatment intensification [specified as SSFMI*]. Penalised logistic regression model-based standardisation was applied to estimate the relative risks [RR] of early therapy on outcomes. RRs were estimated for high-risk and low-risk patients, based on presence of predictors of poor outcome [POPOs] and disease activity at diagnosis. Results In total, 331 children (median age 13.9 years [IQR 12.2–15.3]) were enrolled, with 135 [41%] receiving early anti-TNF. At 1 year, patients on early anti-TNF had higher rates of SSFR* [30% vs 14%, p <0.001] and SSFMI* [69% vs 33%, p <0.001], with RRs of 2.95 [95% CI 1.63-5.36] and 4.67 [95% CI 2.46-8.87], respectively. At 1 year, the RRs for SSFMI* were higher, and statistically significant in high-risk patients, i.e. those with moderate/severe disease compared with mild/inactive disease at diagnosis (5.50 [95% CI 2.51-12.05] vs 2.91 [95% CI 0.92-9.11]), and those with any POPO compared with no POPO (5.05 [95% CI 2.45-10.43] vs 3.41 [95% CI 0.54-21.7]). Conclusion In this cohort of children with newly-diagnosed CD, early anti-TNF demonstrated superior effectiveness in high-risk patients.

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Similar Growth Outcomes in Children with Inflammatory Bowel Disease Initiated on Infliximab Originator or Biosimilar

Cited by 3 publications

References 35 publications

Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease

Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease

Change from originator infliximab to biosimilar does not affect 1‐year outcome in children with inflammatory bowel disease

Improved Clinical Outcomes With Early Anti-Tumour Necrosis Factor Alpha Therapy in Children With Newly Diagnosed Crohn’s Disease: Real-world Data from the International Prospective PIBD-SETQuality Inception Cohort Study

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