06 Oct Biologics Slightly Increase Risk of Demyelinating Disease In Patients with IBD
MedicalResearch.com Interview with:
Nynne Nyboe Andersen, MD
Department of Epidemiology Research
Statens Serum Institut
Denmark
Medical Research: What is the background for this study?
Response: The use of TNF-α inhibitors, including infliximab, adalimumab and certolizumab pegol to treat people with inflammatory bowel disease is increasing worldwide and has improved the medical treatment modalities. However, in the post-marketing period, case-reports, data from retrospective cohort studies and spontaneous reporting systems have identified patients with inflammatory bowel disease treated with TNF-α inhibitors, developing a demyelinating event of the central nervous system. It remains unanswered whether this reflect a true association between TNF-α inhibitors and demyelinating diseases or whether these cases are a result of the well-established underlying association between demyelinating diseases and inflammatory bowel disease per se.
The rarity of demyelinating diseases has stalled a thorough safety evaluation through analytical studies. Consequently, by use of the nationwide Danish registries, we conducted a large population-based cohort study, aiming to address the risk of demyelinating events of the central nervous system in patients with inflammatory bowel disease treated with TNF-α inhibitors compared to untreated patients.
Medical Research: What are the main findings?
Response: Using a matched study design, a 2-fold increased risk of demyelinating diseases was observed in patients with inflammatory bowel disease treated with TNF-α inhibitors compared to untreated. The absolute risk was low with less than four additional cases per 10000 person years in those treated compared to untreated. The rarity of demyelinating diseases limited the statistical power and capacity to adjust for or match on potential confounder variables, and therefore findings should be considered preliminary as they could be a result of chance or unmeasured confounding and need confirmation in other studies.
Medical Research: What should clinicians and patients take away from your report?
Response: The several limitations inherent to our study encourage to careful interpretation. Until more robust data are available, TNF-α inhibitors should be withheld in patients with an own or family history of demyelinating, and if patients develop signs of demyelinating during ongoing treatment, therapy should be discontinued promptly. For the patient it is important to emphasize that the absolute risk seem very limited.
Medical Research: What recommendations do you have for future research as a result of this study?
Response: Despite bringing novel data on the relative risk of demyelinating diseases associated with TNF-α inhibitors, our study findings need confirmation in even larger scale studies with increased methodological robustness and precision.
Citation:
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Nynne Nyboe Andersen, MD (2015). Biologics Slightly Increase Risk of Demyelinating Disease In Patients with IBD
Last Updated on October 6, 2015 by Marie Benz MD FAAD