Outcomes, dosing, and predictors of vedolizumab treatment in children with inflammatory bowel disease (VEDOKIDS): a prospective, multicentre cohort study

Atia, Ohad; Shavit-Brunschwig, Zivia; Mould, Diane R.; Stein, Ronen; Matar, Michael A.; Aloi, Marina; Ledder, Oren; Focht, Gili; Urlep, Darja; Hyams, Jeffrey S.; Broide, Efrat; Weiss, Batia; Levine, Jeremiah; Russell, Richard K.; Turner, Dan

doi:10.1016/s2468-1253(22)00307-7

Cited by 34 publications

(24 citation statements)

References 33 publications

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“…As highlighted by Vuijk and de Ridder, 1 ulcerative colitis (UC) patients had higher serum vedolizumab trough concentrations than Crohn's disease (CD) patients. Interestingly, this observation was also reported by two prior (paediatric) PK analyses from a phase II trial and a multicentre cohort study 4,5 . Whether these differences in trough concentrations are a reflection of higher drug clearance between CD and UC (secondary to differences in disease mechanism) and/or a variation in the extent of the inflammatory burden is not clear.…”

Section: Figurementioning

confidence: 56%

“…Interestingly, this observation was also reported by two prior (paediatric) PK analyses from a phase II trial and a multicentre cohort study. 4,5 Whether these differences in trough concentrations are a reflection of higher drug clearance between CD and UC (secondary to differences in disease mechanism) and/or a variation in the extent of the inflammatory burden is not clear. Unfortunately, our current sample size was too limited to reach additional exposure-response conclusions using sensitivity analyses.…”

Section: Editorial: Achievements and Unresolved Questions In Improvin...mentioning

confidence: 99%

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Editorial: achievements and unresolved questions in improving the pharmacokinetics of vedolizumab in adolescents with inflammatory bowel disease—authors' reply

Colman

Minar

2023

Aliment Pharmacol Ther

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Section: Figurementioning

confidence: 56%

Section: Editorial: Achievements and Unresolved Questions In Improvin...mentioning

confidence: 99%

Editorial: achievements and unresolved questions in improving the pharmacokinetics of vedolizumab in adolescents with inflammatory bowel disease—authors' reply

Colman

Minar

2023

Aliment Pharmacol Ther

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“…Most SAEs in previous reports were exacerbation of UC, but in some cases, infusion reactions, viral infections, and leukocytoclastic vasculitis were reported as SAEs. 7,8,10,12,13,22,23 VDZ is relatively safe for pediatric patients with IBD, but we should be alert for AEs, such as infusion reactions, a fever, or headache, as with other biologics.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of vedolizumab in pediatric patients with ulcerative colitis: multicenter study in Japan

Yokoyama

Yamamoto

Nambu

et al. 2023

J of Gastro and Hepatol

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Background: Vedolizumab (VDZ) is a humanized monoclonal antibody that binds to α4β7 integrin expressed in T-lymphocytes and is gut selective. Few studies have evaluated the safety and efficacy of VDZ in pediatric ulcerative colitis (UC) patients, especially from Asia. Methods: A longitudinal multicenter retrospective study was conducted at 10 Japanese tertiary medical institutions. Patients aged ≤18 years old who received VDZ for UC between January 2019 and July 2021 were enrolled. Information on the clinical characteristics, prior/concomitant treatment, and safety during the observation period was collected. Results: The data obtained from 48 patients (males, n = 30; females, n = 18) were analyzed. The median age at VDZ induction was 14 (range 4-18) years old. VDZ was indicated in 73% of patients as switching from previous biologics due to primary failure, loss of response, and adverse events (AEs) and was the first biologic in 27%. Remission was achieved or maintained at weeks 14, 30, and 54 in 79.2%, 75.0%, and 65.8% of patients, respectively. There were no significant differences between the number of previous biologics exposures and VDZ effectiveness. The hematocrit, serum albumin concentrations, and erythrocyte sedimentation rate (ESR) at baseline differed significantly by VDZ effectiveness. Nine AEs, including infusion reaction, were noted in seven (14.3%) patients. There were no severe AEs related to VDZ administration. Conclusions: VDZ was safe and effective in children with UC. The hematocrit, albumin, and ESR at VDZ initiation might be predictors for VDZ effectiveness. VDZ may be an important option for pediatric patients and can be used as an alternative to immunomodulators.

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“…Atia et al reported that 42% of children with UC treated with vedolizumab achieved steroid-free remission at 14 weeks, even after 68% had failed with a different biologic agent. 20 Dhaliwal et al reported that 44% of their pediatric UC patients treated with ustekinumab (11 of 25) achieved steroid-free remission at 52 weeks, even though all their patients had failed previous IFX therapy. 21 In the ENVISION I study, 60% of pediatric UC patients receiving high-dose adalimumab weekly had achieved clinical remission at 8 weeks, and 45% of patients still maintained remission at 52 weeks.…”

Section: Discussionmentioning

confidence: 99%

Prognosis of pediatric ulcerative colitis after infliximab failure: A multicenter registry‐based cohort study

Nambu,

Kudo,

Tachibana

et al. 2023

J of Gastro and Hepatol

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Background and AimEven with increasing numbers of biologic agents available for management of ulcerative colitis (UC), infliximab (IFX) retains an important place in treatment of pediatric patients with this disease. As few reports have addressed outcomes in pediatric UC patients who had to discontinue IFX, we examined clinical course and prognosis after IFX failure in pediatric UC.MethodsA prospective cohort study of pertinent cases enrolled in the Japanese Pediatric Inflammatory Bowel Disease Registry between 2012 and 2020 was conducted to determine outcomes for pediatric UC patients who received IFX but required its discontinuation during follow‐up (IFX failure).ResultsOf the 301 pediatric UC patients in the registry, 75 were treated with IFX; in 36 of these, IFX was discontinued during follow‐up. Severity of UC at onset and absence of concomitant immunomodulator therapy were significant risk factors for IFX failure (P = 0.005 and P = 0.02, respectively). The cumulative colectomy rate after IFX failure was 41.3% at 1 year and 47.5% at 2 years. Colectomy was significantly more frequent when IFX was discontinued before June 1, 2018, than when IFX was discontinued later (P = 0.013). This difference likely involves availability of additional biologic agents for treatment of UC beginning in mid‐2018 (P = 0.005).ConclusionIn pediatric UC patients, approximately 50% underwent colectomy during a 2‐year interval following IFX failure. Prognosis after IFX failure appeared to improve with availability of new biologic agents and small‐molecule drugs in mid‐2018.

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Outcomes, dosing, and predictors of vedolizumab treatment in children with inflammatory bowel disease (VEDOKIDS): a prospective, multicentre cohort study

Cited by 34 publications

References 33 publications

Editorial: achievements and unresolved questions in improving the pharmacokinetics of vedolizumab in adolescents with inflammatory bowel disease—authors' reply

Editorial: achievements and unresolved questions in improving the pharmacokinetics of vedolizumab in adolescents with inflammatory bowel disease—authors' reply

Safety and efficacy of vedolizumab in pediatric patients with ulcerative colitis: multicenter study in Japan

Prognosis of pediatric ulcerative colitis after infliximab failure: A multicenter registry‐based cohort study

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