The association between biologic agents and the risk of cardiovascular events in patients with psoriasis and psoriatic arthritis A protocol for a systematic review and meta-analysis

Background: Psoriasis (Pso) is a chronic, recurrent, and inflammatory disease involving genetic and immune factors. Psoriatic arthritis (PsA), accounting for 30% of Pso, is an inflammatory arthropathy. Pso and PsA are associated with increased cardiovascular events (CVEs). Biologic therapies for Pso and PsA are drawing arising attention for its therapeutic effects. Large evidences have shown that biologic agents could lower the risk of CVEs in patients with Pso and PsA. However, not all studies support this point. A systematic review is needed. Methods: Four databases (PubMed, Web of Science, The Cochrane Library, and EMBASE) will be searched from the inception to July 1st, 2019. Randomized controlled trials and observational studies (including case-control studies and cohort studies) reporting CVEs in patients with Pso and PsA treated with biologic agents will be included. The primary outcome is the incidence of CVEs. The secondary outcome is the incidence of each individually reported cardiovascular event. Study selection, data extraction, and assessment of quality will be conducted independently by 2 reviewers. RevMan5.3.5 software will be used for data synthesis. Results: The results of this study will provide evidence for the effect of biologic agents on the risk of CVEs in patients with Pso and PsA, so as to further provide guidance for clinical management. Conclusion: The findings of this study will be published in a peer-reviewed journal. PROSPERO registration number: CRD42019142778