scholarly journals Impact of treatment with immunomodulators and tumour necrosis factor antagonists on the incidence of infectious events in patients with inflammatory bowel disease

2022 ◽  
Vol 127 ◽  
Author(s):  
Per Andersson ◽  
Pontus Karling
Keyword(s):  
Inflammatory Bowel Disease ◽  
Combination Therapy ◽  
Tumour Necrosis Factor ◽  
Bowel Disease ◽  
Tumour Necrosis ◽  
Significant Risk ◽  
Significant Difference ◽  
Inflammatory Bowel ◽  
Necrosis Factor ◽  
Observation Period

Background: Corticosteroids, immunomodulators (IM) and tumour necrosis factor antagonists (anti-TNF) are commonly used in the treatment of inflammatory bowel disease (IBD) but they also supress the defence against infectious disease. The aim of this study was to analyse the incidence of infectious events in patients with IBD and the association to concomitant medical therapy. Methods: We performed a retrospective medical chart review of patients with IBD aged 18–65 years included in the Swedish Registry of Inflammatory Bowel Disease in the catchment area of Umeå University Hospital, Sweden. Data were collected from the period 01 January 2006, to 31 January 2019. An infectious event was defined as an outpatient prescription of antimicrobials or a positive diagnostic test for infection. Results: During a period of 5,120 observation-years, we observed 1,394 events in 593 patients. The mean number of infectious events per 100 person-years was 27.2 (standard deviation [SD]: 0.46). There were no differences in mean incidence rates between patients treated with no immunosuppression (23.0 events per 100 person-years, SD: 50.4), patients treated with IM monotherapy (27.6 events per 100 person-years, SD: 49.9), patients treated with anti-TNF monotherapy (34.3 events per 100 person-years, SD: 50.1) and patients on combination therapy (22.5 events per 100-person-years, SD: 44.2). In a multivariate logistic regression, female gender (adjusted odds ratio [AOR]: 2.24; 95% confidence interval [CI]: 1.49–3.37) and combination therapy (AOR: 3.46; 95% CI: 1.52–7.85) were associated with higher risks of infection (>32 events per 100 person years). Also, patients treated with any immunosuppression treatment for 25–75% (AOR: 2.29; 95% CI: 1.21–4.34) and for >75% (AOR: 1.93; 95% CI: 1.19–3.12) of the observation period were at higher risks compared to patients treated with immunosuppression <25% of the observation period. Conclusion: We observed no significant difference in risk for infections between patients on monotherapy with IM or anti-TNF and patients with low use of immunosuppression, but there was a significant risk for combination therapy.

scholarly journals P356 Infectious events in patients with inflammatory bowel disease: The impact of immunomodulators and tumour necrosis factor antagonist therapy

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S338-S339
Author(s):  
P Andersson ◽  
P Karling
Keyword(s):  
Inflammatory Bowel Disease ◽  
Combination Therapy ◽  
Tumour Necrosis Factor ◽  
Bowel Disease ◽  
Tumour Necrosis ◽  
Antagonist Therapy ◽  
Tumour Necrosis Factor Antagonist ◽  
Inflammatory Bowel ◽  
Factor Antagonist ◽  
Necrosis Factor

Abstract Background Immunomodulators (IM) and tumour necrosis factor antagonist therapy (anti-TNF) are effective treatments for inflammatory bowel disease (IBD) but has been associated with an increased risk for infectious diseases. We investigated the frequency of infectious events in patients with IBD and the association of infectious events with concomitant treatment with IM and anti-TNF therapy. Methods We performed a retrospective medical chart review of patients with IBD, 18 to 65 years of age, included in the Swedish Registry of IBD (SWIBREG) and treated in the catchment area of Umeå University Hospital, Sweden. Data were collected from the period January 1, 2006, to January 31, 2019. An infectious event was defined as an outpatient prescription of antimicrobials or a positive diagnostic test for infection. Results Among the 593 included patients (397 patients with UC and 195 patients with CD), 1398 events occurred. The proportion of events that occurred on treatment with corticosteroids, IM, anti-TNF, combination therapy (IM + anti-TNF) and without any immunosuppressive treatments was 8.3%, 35.8%, 17.7%, 10.0% and 47.4%. Of all patients, 60.4% had at least one infectious event, and 29.3% had &gt;0.3 events per year. Compared with patients not receiving immunosuppressive therapy, an event rate of &gt;0.3 per year was more common among those receiving immunomodulator monotherapy or combination therapy (Table), and was more common in patients with Crohn’s disease than ulcerative colitis (35.0% vs. 26.1%, p = 0.022). There were no significant differences in infectious events between patients who had received immunomodulator monotherapy and patients who had received combination therapy. Conclusion We found an increased frequency of infection associated with the use of combination therapy and immunomodulator monotherapy, but no difference between the two treatments.

scholarly journals P809 Increase of tuberculosis due to combination therapy in inflammatory bowel disease: a nationwide population-based study in Korea

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S632-S632
Author(s):  
S J Choi ◽  
E S Kim ◽  
J M Lee ◽  
H S Choi ◽  
B Keum ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Combination Therapy ◽  
Tumour Necrosis Factor ◽  
Bowel Disease ◽  
Tumour Necrosis ◽  
Large Population ◽  
Population Data ◽  
Population Based ◽  
Inflammatory Bowel ◽  
Necrosis Factor

Abstract Background Recent researches reported that inflammatory bowel disease (IBD) in Asia has become more prevalent. Since IBD is chronic inflammation disorder and its relapse is frequent, obtaining and maintaining remission is important. As our knowledge on the pathogenesis of IBD deepened, many immunosuppressants and biological agents were introduced and confirmed to be both safe and effective. However, biologics known as anti-tumour necrosis factor (anti-TNF) agents was reported to lose response over time in 23–46% of patients. Therefore, combination therapy adding immunomodulator drug such as azathioprine was introduced and showed better outcome by optimising biologic pharmacokinetics and minimising immunogenicity. Adversely, rates of tuberculosis are increased, but there is no large population data estimating and comparing these risk in combination therapy. Methods We used 2008–2016 data of the South Korean Health Insurance and Review Agency (HIRA), and odd ratio (OR) for tuberculosis in IBD patients who underwent anti-tumour necrosis factor (TNF) agent, azathioprine, or combination therapy. Results Between 2008 and 2016, 47,760 patients were newly diagnosed as IBD, 29,440 as UC and 15,320 as CD. We compared the risk of tuberculosis according to the medication divided into 5 groups; infliximab only, azathioprine only, combination of azathioprine and infliximab, azathioprine monotherapy and infliximab monotherapy, and azathioprine and infliximab whether simultaneously or separately. We also compared the risk between male and female. Hazard ratio of tuberculosis in infliximab monotherapy, azathioprine, and combination therapy in IBD patients were 1.132, 1.256, and 2.118, respectively. Conclusion Our study shows that Korean IBD patients are at risk for tuberculosis, and this results may highlight the importance of screening for tuberculosis in IBD patients.

scholarly journals P574 Incidence and indicators of suboptimal response to tumour necrosis factor antagonist therapy in Chinese patients with inflammatory bowel disease: Results from the EXPLORE study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S483-S484
Author(s):  
J Li ◽  
Z Li ◽  
P Hu ◽  
Z Wen ◽  
Q Cao ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Tumour Necrosis Factor ◽  
Bowel Disease ◽  
Tumour Necrosis ◽  
Retrospective Chart Review ◽  
Chinese Patients ◽  
First Line ◽  
Related Hospitalisation ◽  
Inflammatory Bowel ◽  
Necrosis Factor

Abstract Background Inflammatory bowel disease (IBD) patients may experience a suboptimal response to anti-tumour necrosis factor (TNF) therapy. In China, these data are limited. The EXPLORE study aimed to assess the incidence and indicators of suboptimal response to first-line anti-TNF agents in IBD patients in real-world practice in the newly industrialised countries. Methods The EXPLORE study was a multinational, retrospective chart review study. In the China subgroup, adult patients from 10 centres diagnosed with ulcerative colitis (UC) or Crohn’s disease (CD) and who initiated first anti-TNF treatment between March 2010 and March 2015, were included. The cumulative incidence (CI) of suboptimal response was assessed over 24 months since the anti-TNF initiation. The indicators of suboptimal response included: IBD-related hospitalisation, dose-escalation, discontinuation including switch to another anti-TNF, non-biologic therapy augmentation, or IBD-related surgery. Primary non-response (PNR) and secondary loss of response (SLOR) were defined as any suboptimal response indicator at &lt;4 and ≥4 months after anti-TNF initiation, respectively. Results Overall, 287 first-line anti-TNF treated patients (35 UC; 252 CD) were included: male, UC 54.3% (n = 19), CD 74.6% (n = 188); mean (SD) age (years), UC 43.1 (14.2), CD 31.9 (11.3); median (min-max) disease duration (years), UC 1.0 (0–9), CD &lt;1 year (0–21); median (min-max) follow-up (months), UC 27.6 (24–60), CD 40.0 (24–60). At 12 and 24 months, the CI of suboptimal response to first anti-TNF treatment was 51.4% and 75.7% in UC, 45.4% and 57.0% in CD, respectively (Figure 1). The median time to the first suboptimal response was 7.2 months in UC and 14.3 months in CD. The CI of PNR was 31.2% in UC and 33.7% in CD. The CI of SLOR was 29.4% and 64.7% in UC, 17.7% and 35.2% in CD at 12 and 24 months, respectively. The most frequent first suboptimal response indicator was ‘discontinuation of anti-TNF therapy’ in UC patients (56.3%) while for CD patients it was ‘IBD-related hospitalisation’ (56.1%) followed by ‘augmentation with non-biological therapy’ in both cohorts (UC 31.3%; CD 22.8%). Conclusion Approximately three-quarters of UC and over half of CD patients experienced a suboptimal response to their first anti-TNF agent at 24 months. Given the high unmet needs observed with anti-TNF therapies in China, IBD patients may benefit from greater optimisation of care and new biologic options.

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