The anti-interleukin-1 receptor antagonist, anakinra, was approved for the treatment of rheumatoid arthritis (RA) more than 12 years ago. However, its adverse effects are not well known. Areas covered: We review the safety profile of anakinra, analyzing clinical trials, observational studies, and registry data. Expert opinion: Due to its lower efficacy compared with other biological therapies approved for RA and its daily subcutaneous administration, anakinra is used only marginally for the treatment of RA. This has limited the experience with this drug in RA, with a lack of data from long-term observational studies or registries. From the five clinical trials performed, and given the unfeasibility of developing new studies of anakinra in RA, it may be concluded that site injection reactions, infections at higher doses (>100 mg), and immunogenicity are the most frequent adverse events related to anakinra administration.
Keywords: Anakinra; clinical trial; review; rheumatoid arthritis; safety.