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

Objective: The objective of this review is to estimate the population-based incidence and to determine the types of severe infection experienced by patients with rheumatoid arthritis who are taking biological agents. Introduction: Since the late 1990s, 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 taking biological agents; 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 lists 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 The search for unpublished studies will include MedNar and OpenGrey. Only studies published in English from 1999 to the present will be included. Screening of studies, assessment of methodological quality, and data extraction will be performed by two independent reviewers. If possible, studies will be pooled in statistical meta-analysis. Systematic review registration number: PROSPERO CRD42020175137