High anti-TNF alfa drugs trough levels are not associated with the occurrence of adverse events in patients with inflammatory bowel disease

Bodini, Giorgia; Demarzo, Maria Giulia; Saracco, Margherita; Coppo, Claudia; Maria, Costanza De; Baldissarro, Isabella; Savarino, Edoardo; Savarino, Vincenzo; Giannini, Edoardo G.

doi:10.1080/00365521.2019.1666914

Cited by 7 publications

(12 citation statements)

References 24 publications

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“…A retrospective study by Greener and colleagues also demonstrated no association between increased infliximab levels (above 15 μg/mL) and the risk of AEs. Similar findings were observed in a study by Bodini and colleagues who examined the association between TNF blockers (infliximab and adalimumab) and AEs [ 8 , 35 ]. As these are retrospective studies and not prospective or cross-sectional, recall bias could have affected patients’ reporting.…”

Section: Discussionsupporting

confidence: 87%

Association of Infliximab and Vedolizumab Trough Levels with Reported Rates of Adverse Events: A Cross-Sectional Study

Veisman

Barzilay

Bruckmayer

et al. 2021

JCM

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Infliximab and vedolizumab are effective treatments for inflammatory bowel disease (IBD), although associated with adverse events (AE). While low or non-existent drug levels and positive antidrug antibodies have been associated with therapeutic failure, there is no clear association between higher drug levels and AE. A cross-sectional study consisting of Crohn’s disease (CD) and ulcerative colitis (UC) patients receiving infliximab or vedolizumab at the Sheba Medical Center was performed. Patients completed a questionnaire regarding AEs related to biological therapy. Serum trough levels obtained on the same day were analyzed. Objective measures of outcomes were retrieved from medical records. Questionnaires were completed by infliximab (n = 169) and vedolizumab (n = 88)-treated therapy patients. Higher infliximab levels were only numerically associated with the occurrence of at least one AE (p = 0.08). When excluding fatigue and abdominal pain, higher infliximab levels were statistically associated with the occurrence of at least one AE (p = 0.03). Vedolizumab drug levels > 18μg/mL were also linked with the occurrence of more AEs. No specific association was observed between the increased levels of either infliximab or vedolizumab and specific AEs (neurological symptoms, upper GI symptoms, infectious complications, and musculoskeletal symptoms). As significant AEs are very rare, additional multi-center studies are required.

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Section: Discussionsupporting

confidence: 87%

Association of Infliximab and Vedolizumab Trough Levels with Reported Rates of Adverse Events: A Cross-Sectional Study

Veisman

Barzilay

Bruckmayer

et al. 2021

JCM

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“…The most effective treatments for patients affected with IBD are immunosuppressive drugs, such as antimetabolites, and biological therapy such as anti‐TNF‐α monoclonal antibodies 10,11 . IBD treatment with these drugs is inherently burdened by some degree of immunosuppression and by a greater likelihood of infections, although there does not seem to be a strong association between the occurrence of infections and biological drug dose 12,13 . This notwithstanding, patients with IBD are often concerned regarding the potential for the occurrence of immunosuppression‐related events, and in general, in patients with IBD, the occurrence of stressor events may represent a trigger for disease relapse 14 …”

Section: Research Lettermentioning

confidence: 99%

Concerns related to COVID‐19 pandemic among patients with inflammatory bowel disease and its influence on patient management

Bodini

Demarzo

Casagrande

et al. 2020

Eur J Clin Investigation

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“…[15][16][17][18] To date, only a few studies [15][16][17][18]21,34 explored the relationship between AE and IFX trough concentration (all retrospectively, except one 17 ). Most studies have been conducted in adults, [15][16][17][18]34 with sample sizes of 83-209 patients and median durations on IFX treatment (6-27 months) shorter than our study. As mentioned earlier, only a single paediatric study 21 examined associations between higher anti-TNF exposure and AEs rate.…”

Section: Discussionmentioning

confidence: 99%

“…These studies failed to demonstrate a clear dose-dependent effect of IFX on skin lesions [11][12][13][14][15] or other AEs. [15][16][17][18] However, paediatric IBD patients have a more severe course compared to adults, requiring more immunosuppressive therapies with the risk of opportunistic infections increasingly being recognized in this population. 19 In addition, younger age at time of anti-TNF initiation in adults has been associated with higher risk of developing skin lesions.…”

Section: Introductionmentioning

confidence: 99%

Identifying risk factors of anti‐TNF induced skin lesions and other adverse events in paediatric patients with inflammatory bowel disease

van Hoeve,

Thomas,

Hillary

et al. 2023

J. pediatr. gastroenterol. nutr.

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ObjectivesWhile higher infliximab (IFX) trough concentrations (TCs) are associated with better outcomes in patients with inflammatory bowel disease (IBD), they could pose a risk for adverse events (AEs), including IFX‐induced skin lesions. Therefore, we studied correlations between IFX TCs and occurrence of AEs in paediatric IBD patients.MethodsIn this single‐centre study, all children with Crohn's disease (CD) and ulcerative colitis (UC) receiving IFX maintenance therapy who underwent proactive drug monitoring between March 2015 and August 2022 were included. IFX doses/intervals/TCs and patient characteristics were systematically registered, as well as AEs and skin lesions appearance.ResultsA total of 109 patients (72 CD and 37 UC) contributed 2913 IFX TCs. During a median follow‐up of 3.0 [1.5–4.5] years, we observed 684 AEs in 101 patients and 49 skin lesions in 35 patients. There was no significant difference (p = .467) in median TCs between patients with and without skin lesions. However, higher median IFX doses were associated with an increased hazard rate of skin lesions [HR 1.084 (1.024–1.148), p = .005], in addition to female sex [2.210 (1.187–5.310), p = .016] and diagnosis of CD [1.695 (1.241–1.877), p = .011]. Considering IFX therapeutic TC cut‐offs of 5.0 and 9.0 µg/mL, there was no significant difference in AE rate (p = .749 and p = .833, respectively). Also, no significant association between IFX doses and AE rate (p = .159).ConclusionsIncreasing the IFX dose to achieve therapeutic TCs may not increase the overall risk of AEs in paediatric IBD patients. However, concerns arise regarding the risk of skin lesions, especially in female CD patients.

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High anti-TNF alfa drugs trough levels are not associated with the occurrence of adverse events in patients with inflammatory bowel disease

Cited by 7 publications

References 24 publications

Association of Infliximab and Vedolizumab Trough Levels with Reported Rates of Adverse Events: A Cross-Sectional Study

Association of Infliximab and Vedolizumab Trough Levels with Reported Rates of Adverse Events: A Cross-Sectional Study

Concerns related to COVID‐19 pandemic among patients with inflammatory bowel disease and its influence on patient management

Identifying risk factors of anti‐TNF induced skin lesions and other adverse events in paediatric patients with inflammatory bowel disease

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