Ischaemic Colitis in Rheumatoid Arthritis Patients Receiving Tumour Necrosis Factor-α Inhibitors: An Analysis of Reports to the US FDA Adverse Event Reporting System

Abstract

TNF-α inhibitors may be initiating factors or co-factors in the development of IC in RA patients, and further research to determine the mechanism of this association is warranted.

Melanoma and non-Melanoma Skin Cancer in Inflammatory Bowel Disease Patients following Tumor Necrosis Factor-α Inhibitor Monotherapy and in Combination with Thiopurines: Analysis of the Food and Drug Administration Adverse Event Reporting System

“…To circumvent these shortcomings in our PRR calculations, we utilized control reactions to ensure that if test drugs or events were reported at an overall increased rate, the OR would remain una ected. However, with these control reactions, the assumption was made that control reactions are not causally related with the study or control drugs [30].…”

Anti-Inflammatory Biologics and Anti-Tumoral Immune Therapies-Associated Colitis: A Focused Review of Literature

“…From the data submitted to United States (US) Food and Drug Administration’s (FDA) Adverse Event Reporting System (AERS) between January 2003 and June 2011, 35 primary suspected reports of TNF- α inhibitors-associated ischemic colitis were identified from 155,372 cases. These patients’ primary indication for therapy was rheumatoid arthritis and other potential causes of ischemic colitis were excluded including sepsis, serious cardiovascular conditions, coagulation disorders or chronic ischemic colitis [ 9 ]. Thirteen of these instances, including seven possible and six probable cases, were reported to be infliximab-associated ischemic colitis with a male to female ratio of 2:11 and median age of 68 years (range 55 - 83).…”

“…After an exploratory laparotomy revealed ischemic colitis, a right colectomy was performed and the patient recovered shortly after hospitalization. But one recent report suggests that the risk of ischemic colitis associated with adalimumab use in patients with rheumatoid arthritis appears to be extremely low as only 12, including seven possible and five probable cases, were reported to be adalimumab-associated ischemic colitis, out of 155,372 cases who had indication of rheumatoid arthritis from the data submitted to US FDA AERS between January 2003 and June 2011[ 9 ]. The male to female ratio was 3:9 and the median age was 58.5 years (range 36 - 79) in this small cohort of patients with adalimumab-associated ischemic colitis.…”

“…From the data submitted to US FDA AERS between January 2003 and June 2011, thirty-five primary suspect reports of TNF- α inhibitors-associated ischemic colitis were identified from 155,372 cases who had indication of rheumatoid arthritis and only three of them, including two possible and one probable case, were reported to be certolizumab-associated. All three patients were female and had median age of 51 years (range 51 - 55) [ 9 ]. One case was confirmed with colonoscopy without biopsy.…”

“…The risk of ischemic colitis associated with etanercept use in patients with rheumatoid arthritis is extremely low. Out of 155,372 cases who had indication of rheumatoid arthritis using the data submitted to US FDA AERS between January 2003 and June 2011, only seven, including two possible and five probable cases, were reported to be etanercept-associated [ 9 ]. The male to female ratio was 1:6 and the median age was 64 years (range 58 - 80) in this small cohort of patients with etanercept-associated ischemic colitis.…”