Lupus & antiphospholipid syndrome

Comparative Safety of Common Immunosuppressant Therapies in Systemic Lupus Erythematosus: A Target Trial Emulation Study

Arthritis RheumatolPublished Target trial emulation study

Authors' conclusion

Initial differences in the infection-related hospitalization risk were attenuated after accounting for time-varying glucocorticoid exposure.

Study context

Population
Patients with nonrenal SLE initiating common immunosuppressants, March 2011–September 2023; excluded prior LN, solid-organ or bone marrow transplantation, or RTX/CYC exposure
Participants
6,168 patients
Comparison
Azathioprine vs belimumab vs methotrexate vs MPAAs
Outcome
Time to first infection-related hospitalisation
Methodological detailsclaims data (Optum Labs Data Warehouse), inverse probability of treatment weighting, marginal structural Cox models, intention-to-treat and per-protocol analyses
  • Claims data (Optum Labs Data Warehouse)
  • Inverse probability of treatment weighting
  • Marginal structural Cox models
  • Intention-to-treat and per-protocol analyses

Main finding

As reported in the abstract

Infection-related hospitalisation, cumulative incidence · 24 months
ITT
Hazard ratio (95% CI)
MPAAsvs Belimumab
1.55(1.07–2.25)
MPAAsvs Methotrexate
1.32(1.04–1.68)

Further findings

OutcomeHR (95% CI)
Infection-related hospitalisation, per-protocol analysisAzathioprinevs BelimumabPP · per-protocol (PP)2.04 (1.01–4.16)
Infection-related hospitalisation, per-protocol analysisMPAAsvs BelimumabPP · per-protocol (PP)2.27 (1.11–4.62)

Infection-related hospitalisation after accounting for time-varying monthly GC dose

Between-treatment differences no longer significant

Original publication

Comparative Safety of Common Immunosuppressant Therapies in Systemic Lupus Erythematosus: A Target Trial Emulation Study. Arthritis Rheumatol. Published 17 September 2026. doi:10.1002/art.70343

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