Risk of serious infections in biological treatment of patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a meta-analysis

The objective of the study is to quantitatively assess the risk of serious infections in patients with axial spondyloarthritis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) treated by biologics enrolled in randomized controlled trials (RCTs). A systematic literature searches of MEDLINE (via PubMed), EMBASE, the Cochrane Library and abstracts archives of the annual scientific meetings of both the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) was conducted through October 2015. The RCTs that compared the safety of any biologics treatment for AS or nr-axSpA with placebo and/or non-steroidal anti-inflammatory drugs (NSAIDs) and/or conventional disease modifying antirheumatic drugs (DMARDs) with a minimum of 12 weeks of follow-up were selected independently by 2 reviewers. Twenty-five RCTs with data from 2403 patients were analyzed in the analysis. Patients included active AS in 21 studies and nr-axSpA in 4 studies were treated by 5 TNF inhibitors (adalimumab, certolizumab, etanercept, golimumab and infliximab) and 3 non-TNF inhibitors (sarilumab, tocilizumab, secukinumab). The risk of serious infections has no difference and numerically was only slightly increased in patients with AS and nr-axSpA treated by biologics compared with controls (OR = 1.42; 95%CI 0.58–3.47). Stratified analysis yielded the pooled risk differences (RDs) of 0.00 (95%CI, − 0.01 to 0.01), 0.01 (95%CI − 0.01 to 0.03), − 0.00 (95%CI −0.01 to 0.01), 0.00 (95%CI − 0.02 to 0.02), 0.01 (95%CI −0.01 to 0.03) and 0.01 (95%CI −0.02 to 0.04) for adalimumab, certolizumab, etanercept, golimumab, infliximab and non-TNF inhibitors respectively. There are also no significant effect of biologics on serious infections was observed compared with controls in patients with AS (p = 0.29) and nr-axSpA (p = 0.89). The use of biologics among patients with AS and nr-axSpA included in RCTs was not significantly associated with an increased risk of serious infections compared with placebo or NSAIDs or DMARDs.