PT  - JOURNAL ARTICLE
AU  - Aureal, Melanie
AU  - Seauve, Milene
AU  - Laplane, Soline
AU  - Lega, Jean-Christophe
AU  - Cabrera, Natalia
AU  - Coury, Fabienne
TI  - Incidence of infections in patients with psoriatic arthritis and axial spondyloarthritis treated with biological or targeted disease-modifying agents: a systematic review and meta-analysis of randomised controlled trials, open-label studies and observational studies
AID  - 10.1136/rmdopen-2023-003064
DP  - 2023 Sep 01
TA  - RMD Open
PG  - e003064
VI  - 9
IP  - 3
4099  - http://rmdopen.bmj.com/content/9/3/e003064.short
4100  - http://rmdopen.bmj.com/content/9/3/e003064.full
SO  - RMD Open2023 Sep 01; 9
AB  - Objective To estimate the incidence of infections among patients with psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), two distinct phenotypes included in the large group of spondyloarthritis (SpA), treated with tumour necrosis-factor-inhibitors, interleukin-17-inhibitors, Janus kinase-inhibitors, IL-23 or IL-12/23-inhibitors (IL-12/23i), phosphodiesterase 4-inhibitors or cytotoxic T-lymphocyte associated protein 4-Ig.Methods A meta-analysis of randomised controlled trials (RCTs), open-label extension and observational studies was conducted. Serious infections were defined as infections that were life-threatening, required intravenous antibiotics and/or hospitalisation. Non-serious infections did not meet these severity criteria. The incidence rates (IR) were reported for each diagnosis by treatment class and study type using random-effect model to create a 95% CI.Results Among 23 333 PsA patients and 11 457 axSpA patients, there were 1.09 serious infections per 100 patient-years (PY) (95% CI 0.85 to 1.35) with similar IR in PsA (0.96 per 100 PY 95% CI 0.69 to 1.28) and axSpA (1.09 per 100 PY 95% CI 0.76 to 1.46). The IR was lower in RCTs (0.77 per 100 PY 95% CI 0.41 to 1.20) compared with observational studies (1.68 per 100 PY 95% CI 1.03 to 2.47). In PsA patients, the lowest IR value was observed with IL-12/23i (0.29 per 100 PY 95% CI 0.00 to 1.03). There were 53.0 non-serious infections per 100 PY (95% CI 43.47 to 63.55) in 7257 PsA patients and 5638 axSpA patients. The IR was higher in RCTs (69.95 per 100 PY 95% CI 61.59 to 78.84) compared with observational studies (15.37 per 100 PY 95% CI 5.11 to 30.97).Conclusion Serious infections were rare events in RCTs and real-life studies. Non-serious infections were common adverse events, mainly in RCTs.PROSPERO registration number CRD42020196711All data relevant to the study are included in the article or uploaded as supplementary information.