Discrepancy between patient‐ and healthcare provider‐reported adverse drug reactions in inflammatory bowel disease patients on biological therapy

Thomas, Pepijn W. A.; Römkens, Tessa E H; West, Rachel; Rüssel, Maurice G.; Jansen, Jeroen M.; Lint, Jette A. van; Jessurun, Naomi T; Hoentjen, Frank

doi:10.1002/ueg2.12107

Cited by 11 publications

(6 citation statements)

References 23 publications

(54 reference statements)

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“…GI intolerance was the most reported AE in our cohort. GI intolerance was reported by patients instead of physicians which may explain the high number of patients detected with GI intolerance, as normally, physicians report and tend to underreport these complaints 31 . Other AEs, such as hepatotoxicity, infections and malaise (Table 2) occurred as well during follow‐up, leading to a quite high number of patients with significant side effects.…”

Section: Discussionmentioning

confidence: 99%

Therapeutic drug monitoring of methotrexate in patients with Crohn's disease

van de Meeberg,

Fidder,

Oldenburg

et al. 2023

Aliment Pharmacol Ther

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SummaryBackgroundTherapeutic drug monitoring (TDM) has the potential to improve efficacy and diminish side effects. Measuring methotrexate‐polyglutamate (MTX‐PG) in erythrocytes might enable TDM for methotrexate in patients with Crohn's disease (CD).AimTo investigate the relationship between MTX‐PGs and methotrexate drug survival, efficacy and toxicityMethodsIn a multicentre prospective cohort study, patients with CD starting subcutaneous methotrexate without biologics were included and followed for 12 months. Primary outcome was subcutaneous methotrexate discontinuation or requirement for step‐up therapy. Secondary outcomes included faecal calprotectin (FCP), Harvey Bradshaw Index (HBI), hepatotoxicity and gastrointestinal intolerance. Erythrocyte MTX‐PGs were analysed at weeks 8, 12, 24 and 52 or upon treatment discontinuation.ResultsWe included 80 patients with CD (mean age 55 ± 13y, 35% male) with a median FCP of 268 μg/g (IQR 73–480). After the 12‐month visit, 21 patients (26%) were still on subcutaneous methotrexate monotherapy. Twenty‐one patients stopped because of disease activity, 29 because of toxicity, and four for both reasons. Five patients ended study participation or stopped methotrexate for another reason. A higher MTX‐PG3 concentration was associated with a higher rate of methotrexate drug survival (HR 0.86, 95% CI 0.75–0.99), lower FCP (β −3.7, SE 1.3, p < 0.01) and with biochemical response (FCP ≤250 if baseline >250 μg/g; OR 1.1, 95% CI 1.0–1.3). Higher MTX‐PGs were associated with less gastrointestinal intolerance. There was no robust association between MTX‐PGs and HBI or hepatotoxicity.ConclusionsHigher MTX‐PG3 concentrations are related to better methotrexate drug survival and decreased FCP levels. Therefore, MTX‐PG3 could be used for TDM if a target concentration can be established.

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Section: Discussionmentioning

confidence: 99%

Therapeutic drug monitoring of methotrexate in patients with Crohn's disease

van de Meeberg,

Fidder,

Oldenburg

et al. 2023

Aliment Pharmacol Ther

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“…Because health care providers might underreport side effects, both patients and physicians are asked about the occurrence of side effects [ 66 ]. If any side effects occur, respondents are asked to clarify the time of onset, severity, and if there are any persisting side effects after medication dosage was changed or stopped.…”

Section: Methodsmentioning

confidence: 99%

Digital Outcome Measurement to Improve Care for Patients With Immune-Mediated Inflammatory Diseases: Protocol for the IMID Registry

Looijen¹,

Linschoten²,

Brugma³

et al. 2023

JMIR Res Protoc

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Background Despite enormous clinical improvements, due to better management strategies and the availability of biologicals, immune-mediated inflammatory diseases (IMIDs) still have a significant impact on patients’ lives. To further reduce disease burden, provider- as well as patient-reported outcomes (PROs) should be taken into account during treatment and follow-up. Web-based collection of these outcomes generates valuable repeated measurements, which could be used (1) in daily clinical practice for patient-centered care, including shared decision-making; (2) for research purposes; and (3) as an essential step toward the implementation of value-based health care (VBHC). Our ultimate goal is that our health care delivery system is completely aligned with the principles of VBHC. For aforementioned reasons, we implemented the IMID registry. Objective The IMID registry is a digital system for routine outcome measurement that mainly includes PROs to improve care for patients with IMIDs. Methods The IMID registry is a longitudinal observational prospective cohort study within the departments of rheumatology, gastroenterology, dermatology, immunology, clinical pharmacy, and outpatient pharmacy of the Erasmus MC, the Netherlands. Patients with the following diseases are eligible for inclusion: inflammatory arthritis, inflammatory bowel disease, atopic dermatitis, psoriasis, uveitis, Behçet disease, sarcoidosis, and systemic vasculitis. Generic and disease-specific (patient-reported) outcomes, including adherence to medication, side effects, quality of life, work productivity, disease damage, and activity, are collected from patients and providers at fixed intervals before and during outpatient clinic visits. Data are collected and visualized through a data capture system, which is linked directly to the patients’ electronic health record, which not only facilitates a more holistic care approach, but also helps with shared decision-making. Results The IMID registry is an ongoing cohort with no end date. Inclusion started in April 2018. From start until September 2022, a total of 1417 patients have been included from the participating departments. The mean age at inclusion was 46 (SD 16) years, and 56% of the patient population is female. The average percentage of filled out questionnaires at baseline is 84%, which drops to 72% after 1 year of follow-up. This decline may be due to the fact that the outcomes are not always discussed during the outpatient clinic visit or because the questionnaires were sometimes forgotten to set out. The registry is also used for research purposes and 92% of the patients with IMIDs gave informed consent to use their data for that. Conclusions The IMID registry is a web-based digital system that collects provider- and PROs. The collected outcomes are used to improve care for the individual patient with an IMID and facilitate shared decision-making, and they are also used for research purposes. The measurement of these outcomes is an essential step toward the implementation of VBHC. International Registered Report Identifier (IRRID) DERR1-10.2196/43230

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“…In addition, some drugs are relatively expensive. [60][61][62] Therefore, seeking deeper remission may be associated with more adverse reactions and costs, especially for patients with advanced age, immunosuppressed conditions, underlying diseases, high risk of treatment and poor economic status. Consequently, the EDG for intestinal BD in 2020 by the JSBD emphasized that adverse events due to enhanced treatment must be comprehensively considered before upgrading the treatment target.…”

Section: Treatment Targetsmentioning

confidence: 99%

The treatment principles and targets for intestinal Behcet’s disease

2023

Therap Adv Gastroenterol

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Behcet’s disease (BD) is a chronic and recurrent systemic vasculitis involving large, medium and small blood vessels as well as arteries and veins. BD with predominant gastrointestinal manifestations is diagnosed as intestinal BD, which is associated with severe complications such as massive gastrointestinal hemorrhage, perforation, and obstruction. Recently, treat-to-target (T2T) strategies have been successfully used in many chronic diseases and been suggested in the management of BD, while there are no related reviews about the global treatment strategy including treatment principles and targets for intestinal BD in detail. Herein, we review the treatment principles from the aspects of departments of Rheumatology and Gastroenterology. In addition, treatment targets of intestinal BD are reviewed from three aspects such as evaluable markers, effective markers and potency-ratio markers. Some definitions and conceptions from inflammatory bowel disease (IBD) bring us reference and enlightenments.

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Discrepancy between patient‐ and healthcare provider‐reported adverse drug reactions in inflammatory bowel disease patients on biological therapy

Cited by 11 publications

References 23 publications

Therapeutic drug monitoring of methotrexate in patients with Crohn's disease

Therapeutic drug monitoring of methotrexate in patients with Crohn's disease

Digital Outcome Measurement to Improve Care for Patients With Immune-Mediated Inflammatory Diseases: Protocol for the IMID Registry

The treatment principles and targets for intestinal Behcet’s disease

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