Screening prior to biological therapy in Crohn's disease: Adherence to guidelines and prevalence of infections. Results from a multicentre retrospective study

Have, Mike van der; Belderbos, Tim D.; Fidder, Herma H.; Leenders, Max; Dijkstra, Gerard; Peters, Charlotte P.; Eshuis, Emma J.; Ponsioen, Cyriel Y.; Siersema, Peter D.; Oijen, Martijn G.H. van; Oldenburg, Bas

doi:10.1016/j.dld.2014.07.006

Cited by 24 publications

(21 citation statements)

References 28 publications

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“…Our study highlights the lack of HBV screening performed by gastroenterologists prior to the administration of anti-TNF therapy with a screening rate of 28%. This has been shown in other studies that have cited HBV screening rates of 13 to 25% in patients with inflammatory bowel disease initiating anti-TNF therapy [17,18] with higher rates of screening from 2009 to 2010 (36 to 49%, [17]). Such low screening rates are surprising especially given that hepatitis b is under the purview of gastroenterology subspecialty training.…”

Section: Discussionsupporting

confidence: 61%

Gastroenterologists Have Suboptimal Hepatitis B Virus Screening Rates in Patients Receiving Immunosuppressive Therapy

et al. 2016

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Section: Discussionsupporting

confidence: 61%

Gastroenterologists Have Suboptimal Hepatitis B Virus Screening Rates in Patients Receiving Immunosuppressive Therapy

et al. 2016

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“…In a meta-analysis of 6 cohorts, TNFi þ IS was associated with a 19% higher risk of serious infection as compared with TNFi monotherapy (RR, 1.19; 95% CI, 1.03-1.37), with minimal heterogeneity (I 2 ¼ 8%) (Figure 3). [15][16][17]20,21,28 The overall results were consistent in subgroup analysis based on adjustment for IBD disease severity, prior infections, study design, and analysis approach (Table 2).…”

Section: Tumor Necrosis Factor Inhibitor-based Combination Therapy Vssupporting

confidence: 55%

“…From 11,947 unique studies identified using our search strategy, the full text of 115 studies were reviewed in detail, and eventually 15 studies were included in the quantitative analysis [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] ; in addition, 3 studies comparing TNFi-based therapy vs chronic corticosteroids and non-TNFi biologics vs TNFi-based therapy were evaluated qualitatively. [30][31][32] Figure 1 shows the study selection flowsheet.…”

Section: Resultsmentioning

confidence: 99%

“…[18][19][20][21][22][23][24][25][26] Three of these studies were sponsored postmarketing registry studies, [15][16][17] and 3 studies involved single-center or multicenter cohorts. [27][28][29] Table 1 shows the study-level characteristics of included studies. Eight studies were conducted in Europe, and 4 studies were conducted in North America.…”

Section: Resultsmentioning

confidence: 99%

“…In contrast, combination therapy of TNFi þ corticosteroids was associated with a 64% higher risk of serious infection as compared with TNFi monotherapy (4 cohorts: RR, 1.64; 95% CI, 1.33-2.03), with minimal heterogeneity (I 2 ¼ 8%). 15,17,28,29 Similarly, the combination of TNFi þ immunomodulators þ corticosteroids was associated with a 35% higher risk of serious infection as compared with TNFi monotherapy (2 cohorts: RR, 1.35; 95% CI, 1.04-1.77). 15,28…”

Section: Tumor Necrosis Factor Inhibitor-based Combination Therapy Vsmentioning

confidence: 99%

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Comparative Risk of Serious Infections With Biologic and/or Immunosuppressive Therapy in Patients With Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis

Singh

Facciorusso

Dulai

et al. 2020

Clinical Gastroenterology and Hepatology

152

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This article has an accompanying continuing medical education activity, also eligible for MOC credit, on page e7. Learning Objective-Upon completion of this activity, successful learners will be able to list the relative risk of serious infection with various treatment strategies in patients with inflammatory bowel disease; and in addition to biologic and immunomodulator therapies, list risk factors for serious infections in patients with inflammatory bowel diseases. BACKGROUND & AIMS: We performed a systematic review and meta-analysis to evaluate the comparative risk of serious infections with tumor necrosis factor (TNF) antagonists, non-TNF targeted biologics, tofacitinib, and immunosuppressive agents in patients with inflammatory bowel diseases (IBDs). METHODS: In a systematic search of publications, through March 18, 2018, we identified 15 observational studies (>500 person-years) of patients with IBD treated with TNF antagonists, non-TNF targeted biologics, tofacitinib, and/or immunosuppressive agents (thiopurines, methotrexate) that reported risk of serious infections. Only studies with active comparators were included, to allow appropriate comparative synthesis. We performed random-effects meta-analysis and estimated relative risk (RR) and 95% CIs. RESULTS: Compared with anti-TNF monotherapy, risk of serious infection increased with the combination of anti-TNF and an immunosuppressive agent (in 6 cohorts: RR, 1.19; 95% CI, 1.03-1.37), with anti-TNF and a corticosteroid (in 4 cohorts: RR, 1.64; 95% CI, 1.33-2.03), or with all 3 drugs (in 2 cohorts: RR, 1.35; 95% CI, 1.04-1.77); there was minimal heterogeneity among studies. In contrast, monotherapy with an immunosuppressive agent was associated with a lower risk of serious infections than monotherapy with a TNF antagonist (7 cohorts: RR, 0.61; 95% CI 0.44-0.84) or a TNF antagonist with an immunosuppressive agent (2 cohorts: RR, 0.56; 95% CI, 0.39-0.81). Infliximab-based therapy was associated with a lower risk of serious infections compared with adalimumab-based therapy in patients with ulcerative colitis (4 cohorts: RR, 0.57; 95% CI, 0.33-0.97), but not Crohn's disease (4 cohorts: RR, 0.91; 95% CI, 0.49-1.70). Few data were available on the comparative safety of biologic agents that do not inhibit TNF and tofacitinib. CONCLUSIONS: Combination therapies for IBD that include TNF antagonists, especially with corticosteroids, are associated with a higher risk of serious infection, whereas monotherapy with an immunosuppressive agent is associated with a lower risk, compared with monotherapy with a TNF antagonist. Studies are needed to evaluate the comparative safety of non-TNF targeted biologics and small molecules for treatment of IBD.

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Implementation of a Best Practice Advisory to Improve Infection Screening Prior to New Prescriptions of Biologics and Targeted Synthetic Drugs

Baker

Fine

Suter

et al. 2023

Arthritis Care & Research

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ObjectiveUse of biologic and targeted synthetic DMARDs (b/tsDMARDs) in patients with pre‐existing tuberculosis (TB), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection can have serious consequences. Although various society guidelines recommend routine screening for these infections prior to initiating certain b/tsDMARDs adherence to these recommendations varies widely. This quality improvement initiative evaluated local compliance with screening and assessed if automated computerized decision support system (CDSS) in the form of a best practice advisory (BPA) in the electronic health record could improve patient screening.MethodsEstablished patients with autoimmune rheumatic disease (ARD) aged 18 years or older with at least one visit to our rheumatology practice between 10/1/2017 and 3/3/2022 were included. When prescribing a new b/tsDMARD, clinicians were alerted via a BPA that showed the most recent results for TB, HBV, and HCV. Screening proportions for TB, HBV, and HCV before BPA initiation were compared with those of eligible patients after the BPA implementation.ResultsA total of 711 patients pre‐BPA and 257 patients post‐BPA implementation were included in the study. The BPA implementation was associated with statistically significant improvement in screening for TB from 66% to 82% (p=<0.001), HCV from 60 to 79% (p=<0.001), hepatitis B core antibody (HBcAb) 32% to 51% (p=<0.001), and hepatitis B surface antigen (HBsAg) from 51% to 70% (p=<0.001).ConclusionImplementation of a BPA can improve infectious disease screening for patients with ARD who are started on b/tsDMARD and has potential to improve patient safety.This article is protected by copyright. All rights reserved.

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Screening prior to biological therapy in Crohn's disease: Adherence to guidelines and prevalence of infections. Results from a multicentre retrospective study

Cited by 24 publications

References 28 publications

Gastroenterologists Have Suboptimal Hepatitis B Virus Screening Rates in Patients Receiving Immunosuppressive Therapy

Gastroenterologists Have Suboptimal Hepatitis B Virus Screening Rates in Patients Receiving Immunosuppressive Therapy

Comparative Risk of Serious Infections With Biologic and/or Immunosuppressive Therapy in Patients With Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis

Implementation of a Best Practice Advisory to Improve Infection Screening Prior to New Prescriptions of Biologics and Targeted Synthetic Drugs

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