Severe infection risk in patients treated with biologics for rheumatoid arthritis: a systematic review protocol.

Objective To estimate the population-based incidence and determine the types of severe infection experienced by patients with rheumatoid arthritis who are taking biological agents. Introduction Since the late 1990 s, a variety of biological and synthetic drugs have been developed to treat rheumatoid arthritis. In recent years, the incidence of severe infection in patients with rheumatoid arthritis in Western nations has been reported by observational studies; however, no systematic review has been conducted on this topic. Inclusion criteria The following criteria will be considered for inclusion: i) observational studies on patients with rheumatoid arthritis who are on biological treatment; ii) studies reporting the number of severe infections requiring hospitalization for treatment; and iii) studies with person-years of observational data. Methods MEDLINE, CINAHL, Embase, and Web of Science will be searched to identify published studies. The reference list of all studies that are selected for critical appraisal will be screened for additional studies. The search for unpublished studies will include MedNar and OpenGrey. Systematic review registration number PROSPERO CRD42020175137.