scholarly journals Do pharmacokinetics justify dose-optimization for loss of response to Vedolizumab in IBD?

@Gijournal ◽  
2021 ◽  
Vol 1 ◽  
Author(s):  
Joseph Sleiman ◽  
Aline Charabaty ◽  
Asad ur Rahman
Keyword(s):  
Tumor Necrosis ◽  
Real Life ◽  
Drug Level ◽  
Dose Optimization ◽  
Therapeutic Drug ◽  
Loss Of Response ◽  
Life Data ◽  
Real Life Data ◽  
Inflammatory Bowel ◽  
Necrosis Factor

Knowledge surrounding therapeutic drug monitoring (TDM) in inflammatory bowel disease is growing, especially for tumor necrosis factor-? inhibitors class of drugs. Yet, TDM for the ?4?7 integrin antibody vedolizumab (VDZ) has not been equally established, as real-life data on VDZ pharmacokinetics, VDZ drug level and treatment response are scarce. We summarize the @GIJournal discussion held on July 14, 2021 during which the article by Ungar et al. “Dose-optimization for loss-of-response to vedolizumab - pharmacokinetics and immune mechanisms” was critically reviewed by our expert Dr. Aline Charabaty (AC), and moderated by Dr. Asad ur Rahman (AR).

scholarly journals Twelve-Year Retention Rate of First-Line Tumor Necrosis Factor Inhibitors in Rheumatoid Arthritis: Real-Life Data From a Local Registry

2016 ◽  
Vol 68 (4) ◽  
pp. 432-439 ◽  
Author(s):  
Ennio Giulio Favalli ◽  
Francesca Pregnolato ◽  
Martina Biggioggero ◽  
Andrea Becciolini ◽  
Alessandra Emiliana Penatti ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumor Necrosis Factor ◽  
Tumor Necrosis ◽  
Retention Rate ◽  
Real Life ◽  
Tumor Necrosis Factor Inhibitors ◽  
First Line ◽  
Life Data ◽  
Real Life Data ◽  
Necrosis Factor

Effectiveness and safety of biologics in pediatric inflammatory bowel disease: Real-life data from the Sicilian Network

2020 ◽  
Vol 44 (2) ◽  
pp. 223-229 ◽  
Author(s):  
Anna Claudia Romeo ◽  
Marco Ventimiglia ◽  
Valeria Dipasquale ◽  
Ambrogio Orlando ◽  
Michele Citrano ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Real Life ◽  
Life Data ◽  
Pediatric Inflammatory Bowel Disease ◽  
Real Life Data ◽  
Inflammatory Bowel

scholarly journals Effectiveness and Safety of the Sequential Use of a Second and Third Anti-TNF Agent in Patients With Inflammatory Bowel Disease: Results From the Eneida Registry

2019 ◽  
Author(s):  
María José Casanova ◽  
María Chaparro ◽  
Miguel Mínguez ◽  
Elena Ricart ◽  
Carlos Taxonera ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Combination Therapy ◽  
Adverse Events ◽  
Bowel Disease ◽  
Tumor Necrosis ◽  
Significant Proportion ◽  
Short Term ◽  
Loss Of Response ◽  
Inflammatory Bowel ◽  
Necrosis Factor

Abstract Background The effectiveness of the switch to another anti–tumor necrosis factor (anti-TNF) agent is not known. The aim of this study was to analyze the effectiveness and safety of treatment with a second and third anti-TNF drug after intolerance to or failure of a previous anti-TNF agent in inflammatory bowel disease (IBD) patients. Methods We included patients diagnosed with IBD from the ENEIDA registry who received another anti-TNF after intolerance to or failure of a prior anti-TNF agent. Results A total of 1122 patients were included. In the short term, remission was achieved in 55% of the patients with the second anti-TNF. The incidence of loss of response was 19% per patient-year with the second anti-TNF. Combination therapy (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.8–3; P < 0.0001) and ulcerative colitis vs Crohn’s disease (HR, 1.6; 95% CI, 1.1–2.1; P = 0.005) were associated with a higher probability of loss of response. Fifteen percent of the patients had adverse events, and 10% had to discontinue the second anti-TNF. Of the 71 patients who received a third anti-TNF, 55% achieved remission. The incidence of loss of response was 22% per patient-year with a third anti-TNF. Adverse events occurred in 7 patients (11%), but only 1 stopped the drug. Conclusions Approximately half of the patients who received a second anti-TNF achieved remission; nevertheless, a significant proportion of them subsequently lost response. Combination therapy and type of IBD were associated with loss of response. Remission was achieved in almost 50% of patients who received a third anti-TNF; nevertheless, a significant proportion of them subsequently lost response.

Therapeutic drug monitoring of adalimumab in inflammatory bowel disease in children

2021 ◽  
Vol 19 (3) ◽  
pp. 14-25
Author(s):  
A.S. Illarionov ◽  
◽  
T.V. Radygina ◽  
A.S. Potapov ◽  
A.P. Fisenko ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Tumor Necrosis ◽  
Therapeutic Drug ◽  
Endoscopic Remission ◽  
Inflammatory Bowel ◽  
Factor Α ◽  
Necrosis Factor

Objective. To evaluate the significance of therapeutic drug monitoring of adalimumab (ADA) concentration levels and antibodies to it in inflammatory bowel disease (IBD) in children. Patients and methods. In this study, 103 children with IBD (24 patients with ulcerative colitis (UC) and 79 with Crohn’s disease (CD)) aged 3–18 years were examined during maintenance therapy with ADA (100 mg/mL in 0.4 mL). Body weight, duration of disease and therapy, use of azathioprine (AZA), achievement of clinical and endoscopic remission, albumin levels, residual levels of ADA and antibodies to the drug, circulating cytokine levels in serum were assessed. Results. A significant decrease in ADA levels in children in the absence of clinical remission in CD (5.21 [3.32; 7.43] μg/mL in remission) and in UC (2.42 [0.42; 4.51] μg/mL, p = 0.001) was shown. A high-quality separation model for residual ADA levels for exacerbation/remission conditions for clinical and endoscopic activity for children with CD and UC was obtained through ROC-analysis. The minimum residual ADA levels for maintaining clinical remission in children with CD were 8.1 μg/mL and 10.5 μg/mL for mucosal healing. In children with UC, as well as in children weighing <40 kg, these levels were higher. The formation of antibodies to ADA was minimal; combination therapy with AZA showed no efficacy. Key cytokines correlating with ADA concentration were interleukins IL-6, -13, -31, -27, -9, and tumor necrosis factor-α. Conclusion. To improve the efficacy of ADA therapy in children with IBD, therapeutic drug monitoring should be performed, considering the nosology and body weight of the child, as well as the goal of therapy (clinical and endoscopic remission). Key words: inflammatory bowel disease, Crohn’s disease, ulcerative colitis, adalimumab, therapeutic drug monitoring, tumor necrosis factor-α, cytokine profile, azathioprine

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