After more than a decade of experience with biologic DMARDs, a vast collection of data on patients submitted to these therapies has been gathered. These data go beyond the evidence from clinical trials and reflect the reality of daily clinical practice. In the last years we have witnessed several important findings stemming from registries, especially the biologic registries, which do now include a significant number of patients followed-up for a reasonable period and enabling conclusions on safety of biologic agents to be drawn. Safety aspects such as infections, malignancies, and cardiovascular events among others have been carefully assessed.
Furthermore, safety of biologic DMARDs can be better put into perspective if safety of synthetic DMARDs is better understood and the literature has also been enriched with safety aspects on patients on synthetic DMARDs compared to the general population.
In order to inform a EULAR Task Force charged with updating the EULAR recommendations for the pharmacologic treatment of RA, two systematic literature reviews (SLR) were performed to assess the safety of biological and synthetic DMARDs.
In the first SLR, studies comparing the incidence rate of safety aspects of biologics with those of synthetic DMARDs in patients with RA were included. Studies using the general population as a comparator were also included. However, one comparator group was always required, so that the occurrence of the safety outcomes could be better interpreted. In the second SLR, safety aspects of patients with RA on synthetic DMARDs were compared to the general population. Safety outcomes found in the literature include infections, malignancies, cardiovascular events, mortality, gastro-intestinal perforation, demyelinating events, hepatic effects and auto-immune events.
Disclosure of Interest None Declared