Efficacy and safety of vedolizumab for pediatrics with inflammatory bowel disease: a systematic review

Fang, Shengbo; Song, Yanqing; Wang, Libo

doi:10.1186/s12887-022-03229-x

Cited by 7 publications

(3 citation statements)

References 51 publications

(114 reference statements)

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“…[3][4][5] Published data in children with IBD treated with vedolizumab is more limited and retrospective in nature, with variable 52-week clinical remission rates (CR) reported of 24%-45%. [6][7][8] Therapeutic drug monitoring (TDM) is the practice of monitoring drug levels to personalize dosages and optimize drug efficacy. The use of TDM with anti-tumor necrosis factor (TNF) therapy has been shown to improve outcomes in children with IBD [9][10][11][12] ; however, more limited data are available regarding the use of TDM with vedolizumab.…”

Section: Introductionmentioning

confidence: 99%

“…These trials were then followed by real‐world studies in adults supporting vedolizumab's effectiveness in treating inflammatory bowel disease (IBD) 3–5 . Published data in children with IBD treated with vedolizumab is more limited and retrospective in nature, with variable 52‐week clinical remission rates (CR) reported of 24%–45% 6–8 …”

Section: Introductionmentioning

confidence: 99%

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Proactive therapeutic drug monitoring and vedolizumab dose optimization in children with inflammatory bowel disease

Rowland,

McNicol,

Kiel

et al. 2024

J. pediatr. gastroenterol. nutr.

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ObjectivesTherapeutic drug monitoring (TDM) and dose optimization have been shown to improve clinical outcomes with antitumor necrosis factor and recent studies in adults suggest an exposure–response relationship with drug levels associated with improved clinical outcomes. However, these levels are not universally recognized as therapeutic targets for vedolizumab dosing. We aimed to assess the impact of a TDM quality improvement (QI) initiative on 52‐week clinical outcomes and describe proactively obtained vedolizumab levels during the induction period in children with inflammatory bowel disease (IBD).MethodsA QI initiative to proactively obtain TDM levels at Week 6 was implemented in 2019. A retrospective review of pediatric patients with IBD treated with vedolizumab from 2018 to 2022 was performed. Baseline demographic data, medication dosing details, disease characteristics, lab results, and 12‐month clinical outcomes were recorded. For this study, we defined therapeutic target levels (>20 μg/mL at Week 6 and >12 μg/mL during maintenance) based on existing data correlating these levels with improved clinical outcomes.ResultsFifty‐nine patients (31 Crohn disease [CD], 28 ulcerative colitis [UC]/indeterminate colitis [IC]) were included in the study. In total, 68% (40/59) of patients had vedolizumab levels at Week 6 and 90% (53/59) had levels drawn at Week 6 or 14. Thirty‐five percent of Week 6 trough levels were below our defined target of 20 μg/mL. Fifty‐two of 59 patients had available data at 52 weeks. Over 80% (42/52) of patients remained on vedolizumab 52 weeks after initiation (CD 79% [23/29], UC/IC 83% [19/23]). Sixty‐two percent (26/42) of patients that remained on vedolizumab at 52 weeks were treated with an intensified dosing interval of <8 weeks. Thirty‐one of these 42 (74%) were in clinical remission (CR) rate at 52 weeks with 29/42 (69%) in corticosteroid‐free remission. The CR rate for the entire cohort including those who discontinued therapy due to a lack of efficacy before 52 weeks was 60% (31/52).ConclusionProactive TDM and early dose optimization with vedolizumab may improve drug durability and clinical outcomes in pediatric patients with IBD.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Proactive therapeutic drug monitoring and vedolizumab dose optimization in children with inflammatory bowel disease

Rowland,

McNicol,

Kiel

et al. 2024

J. pediatr. gastroenterol. nutr.

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“…Despite respiratory tract infections being the most common adverse events (AEs), there is no definitive evidence linking them to vedolizumab. 83,84 Generally, gut-selective mechanisms underpin its safety profile. 85,86 Vedolizumab demonstrates commendable biosafety during IBD flare-ups associated with CMV infection.…”

mentioning

confidence: 99%

Cytomegalovirus Pneumonia in Inflammatory Bowel Disease: Literature Review and Clinical Recommendations

Ren,

Yong,

Wang

et al. 2023

IDR

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The objective was to elucidate the correlation between CMVP and immunosuppressive therapy in IBD patients, we hope this review could expand on the significance of CMV as an opportunistic pathogen and the potential impact on morbidity and mortality in IBD patients. Methods: Records and clinical trajectories linked to CMVP in IBD patients were extracted from the PubMed database, irrespective of language barriers. The reference lists incorporated in these studies were manually inspected. Conclusions were generated using straightforward descriptive analysis. Results: In total, 18 IBD patients, including Crohn's disease (CD, 67%) and Ulcerative Colitis (UC, 33%), affected by CMVP were identified from 17 published articles. A minority of these patients (17%) exhibited active disease, whereas the majority (83%) presented with quiescent disease. Fever (100%) and dyspnea (44%) emerged as the most prevalent clinical symptoms. All the patients had undergone immunosuppressive therapy. A significant proportion, up to 89%, had received thiopurine treatment prior to the CMVP diagnosis. Interestingly, none of the patients were subjected to biological therapy. Half of the patients manifested with Hemophagocytic Lymphohistiocytosis (HLH). Almost all patients (94%) were administered antiviral treatment and a substantial 83% experienced full recovery. Immunosuppressive agents were either tapered or discontinued altogether. A subset of patients, 17%, suffered fatal outcomes. Conclusion: Our findings underscore the need for heightened suspicion of CMVP in IBD patients who exhibit symptoms such as fever and dyspnea. During the COVID-19 pandemic, CMVP should be considered a potential differential diagnosis. It was observed that CMVP primarily transpires during CD remission. Azathioprine emerged as the predominant immunosuppressant linked to CMV reactivation. The prompt application of effective antiviral therapy can substantially enhance patient outcomes. CMV vaccine might serve as a viable prevention strategy.

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Vedolizumab in paediatric IBD: a huge step forward but not there yet

Klomberg¹,

Ridder²

2023

The Lancet Gastroenterology & Hepatology

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Efficacy and safety of vedolizumab for pediatrics with inflammatory bowel disease: a systematic review

Cited by 7 publications

References 51 publications

Proactive therapeutic drug monitoring and vedolizumab dose optimization in children with inflammatory bowel disease

Proactive therapeutic drug monitoring and vedolizumab dose optimization in children with inflammatory bowel disease

Cytomegalovirus Pneumonia in Inflammatory Bowel Disease: Literature Review and Clinical Recommendations

Vedolizumab in paediatric IBD: a huge step forward but not there yet

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