Spondyloarthritis & psoriatic arthritis

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

RMD OpenPublished Systematic review and meta-analysis of randomised controlled trials, open-label studies and observational studies

Authors' conclusion

Serious infections were rare events in RCTs and real-life studies. Non-serious infections were common adverse events, mainly in RCTs.

Study context

Population
Patients with PsA or axial spondyloarthritis (axSpA) treated with TNFi, IL-17i, JAKi, IL-23 or IL-12/23i, phosphodiesterase 4-inhibitors or CTLA4-Ig
Participants
23,333 vs 11,457
Comparison
PsA vs axSpA
  • PsAn = 23,333
  • axSpAn = 11,457
Outcome
Incidence rate of serious infections (life-threatening, requiring intravenous antibiotics and/or hospitalisation)
Methodological detailsrandom-effect model
  • Random-effect model

Pooled result

As reported in the abstract

Serious infections per 100 PY
Overall serious infections per 100 patient-years (PY)
1.09 (95% CI 0.85 to 1.35)

Further pooled results

Serious infections by study type

Randomised controlled trials (RCTs), per 100 PY
0.77 (95% CI 0.41 to 1.20)
Observational studies, per 100 PY
1.68 (95% CI 1.03 to 2.47)
Incidence rates (IR) lower in RCTs than observational studies

Serious infections in PsA with IL-12/23i (lowest IR)

IL-12/23i, per 100 PY
0.29 (95% CI 0.00 to 1.03)

Non-serious infections (7257 PsA and 5638 axSpA patients)

Overall, per 100 PY
53.0 (95% CI 43.47 to 63.55)
RCTs, per 100 PY
69.95 (95% CI 61.59 to 78.84)
Observational studies, per 100 PY
15.37 (95% CI 5.11 to 30.97)

Original publication

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. RMD Open. Published 15 September 2023. doi:10.1136/rmdopen-2023-003064

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