Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis

Ann Rheum Dis doi:10.1136/annrheumdis-2013-204575

Two systematic literature reviews were undertaken to update the safety findings on synthetic and biological DMARDs in order to inform the updates to the EULAR recommendations to the treatment of RA. Of 10,559 articles screened, 49 were included for review covering a diverse range of outcomes. In the main these showed the patients on bDMARDs had a significantly greater risk of serious infections and tuberculosis compared with csDMARDs, while differences in data between studies mean a slight increase in risk of herpes zoster cannot be ruled out. When csDMARDs were used as the comparator cancer, lymphoma and NMSC does not occur more frequently in bDMARD patients alternatively melanoma may occur more frequently. There was no difference in mortality between patients on TNFi and csDMARDs. Twelve papers were screened for csDMARD safety, again with a variety of outcomes. For serious infections, four studies showed no difference in risk across various csDMARDs and new signals across all outcomes for csDMARDs were found.