Table 1.

Crude absolute and relative risk estimates for serious infections in pregnant women with autoimmune inflammatory conditions treated with immunosuppressive agents, Medicaid data 2000-10 and Optum Clinformatics data 2004-15

Population and drug exposure	No of exposed pregnancies	Person years	Serious infection events*	Incidence rate/100 person years (95% CI)	Incidence rate difference/100 person years (95% CI)	Incidence rate ratio (95% CI)
Patients with autoimmune inflammatory conditions†:
Steroid	2598	1162	40	3.4 (2.5 to 4.7)	Ref	Ref
Non-biologics	1587	991	23	2.3 (1.5 to 3.5)	−1.1 (−2.5 to 0.3)	0.68 (0.41 to 1.14)
Patients with autoimmune inflammatory conditions† other than SLE:
Steroid	1879	856	29	3.4 (2.3 to 4.9)	Ref	Ref
Non-biologics	816	509	11	2.2 (1.1 to 3.9)	−1.2 (−3.0 to 0.6)	0.65 (0.32 to 1.3)
TNF inhibitors	776	522	<11‡	1.5 (0.7 to 3.0)	−1.9 (−3.5 to −0.3)	0.44 (0.20 to 0.96)

TNF=tumor necrosis factor α; SLE=systemic lupus erythematosus.

^*Serious infections: a composite outcome consisting of patients admitted to hospital for bacterial (meningitis, encephalitis, cellulitis, endocarditis, pneumonia, pyelonephritis, osteomyelitis, and bacteremia) or opportunistic infections (tuberculosis, systemic candidiasis, cryptococcosis, aspergillosis).

^†Conditions included ankylosing spondylitis, inflammatory bowel disease, psoriatic arthritis, rheumatoid arthritis, and SLE. TNF inhibitors are not indicated for the treatment of SLE and therefore patients with only SLE were excluded from comparisons concerning TNF inhibitors.

^‡Actual numbers are suppressed for counts <11 as required by data use agreement with the Centers for Medicare and Medicaid Services.