11 Jun Treatment With TNF-α inhibitors Raises Short Term Risk Of Infection in Inflammatory Bowel Disease
MedicalResearch.com Interview with:
Nynne Nyboe Andersen, MD, PhD student
Department of Epidemiology Research
Statens Serum Institut
Medical Research: What is the background for this study? What are the main findings?
Dr. Andersen: The use of TNF-α inhibitors, including infliximab, adalimumab and certolizumab pegol to treat people with inflammatory bowel disease is increasing worldwide and has upgraded the medical treatment modalities. However, concerns about their safety, including an increased risk of serious infections have persisted because they suppress the immune system. Previous meta-analyses based on randomized controlled trials did not suggest an increased risk of serious infections in people with inflammatory bowel disease treated with TNF-α inhibitors compared to placebo. However, the trials included in the meta-analyses were designed to investigate efficacy, and not to analyze risk of rare adverse events such as serious infections and often represent selected populations. Therefore, observational studies are essential to evaluate safety in a real world setting; however, results from these studies have been conflicting. Thus, as the risk of infections associated with TNF-α inhibitor treatment in people with inflammatory bowel disease is unclear we aimed at investigating this potential risk in a population-based setting based on the entire Danish inflammatory bowel disease population.
In a propensity score matched cohort we found a significant 63% increased risk of serious infections within 90 days after treatment initiation. When we prolonged follow-up to 356 days the risk was attenuated and no longer significant. For site-specific serious infections, we found increased point estimates for sepsis, urological/gynecological infections, and skin and soft tissue infections; but these results should be interpreted cautiously because of limited power.
Medical Research: What should clinicians and patients take away from your report?
Dr. Andersen: Our study provides the clinicians with an updated safety profile regarding infections risk associated with TNF-α inhibitors based on the entire Danish population with inflammatory bowel disease and these results can most likely be extended to other Western countries. It is important to stress that the benefit of TNF-α inhibitor treatment in people with inflammatory bowel disease is unquestionable nevertheless our findings call for increased clinical awareness of potential infectious complications among people using these drugs, especially early in the course of treatment.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Andersen: Our study’s ability to conclude on specific infections and on different TNF-α inhibitors separately was limited because of power issues and should be assessed in future even larger scale population-based studies.
Nyboe Andersen Nynne, Pasternak Björn, Friis-Møller Nina, Andersson Mikael, Jess Tine. Association between tumour necrosis factor-α inhibitors and risk of serious infections in people with inflammatory bowel disease: nationwide Danish cohort study
BMJ 2015; 350 :h2809
Nynne Nyboe Andersen, MD, PhD student Department of Epidemiology Research, Statens Serum Institut, & Copenhagen, Denmark (2015). Treatment With TNF-α inhibitors Raises Short Term Risk Of Infection in Inflammatory Bowel Disease MedicalResearch.com