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. Author manuscript; available in PMC: 2019 Jun 1.
Published in final edited form as: Ann Rheum Dis. 2018 Feb 20;77(6):855–860. doi: 10.1136/annrheumdis-2017-212535

Table 4.

ModificationA by hydroxychloroquine of hazard ratios for the association of pregnancy and lupus flares: the Hopkins Lupus Cohort, 1987–2015 (n=1349).

Patients Exposed to HCQ Patients Unexposed to HCQ

Flares PY Crude Incidence per 100 PY HRB (95% CI) Flares PY Crude Incidence per 100 PY HRB (95% CI)

PGAC
12-Month Postpartum Period
 Not pregnant/postpartum 1458 3843.0 38.0 1.0 (ref) 788 1740.3 45.3 1.0 (ref)
 Pregnancy 52 123.4 42.1 1.26 (0.88, 1.69) 82 97.3 84.3 1.83 (1.34, 2.45)
 12-months postpartum 75 212.2 35.3 1.02 (0.72, 1.32) 73 158.7 46.0 0.98 (0.67, 1.31)
3-Month Postpartum Period
 Not pregnant/postpartum 1510 3967.3 38.1 1.0 (ref) 826 1819.0 45.4 1.0 (ref)
 Pregnancy 52 123.4 42.1 1.24 (0.86, 1.73) 82 97.3 84.3 1.84 (1.37, 2.44)
 3-months postpartum 23 51.6 44.6 1.25 (0.71, 1.87) 35 44.0 79.5 1.63 (1.04, 2.39)
SELENA-SLEDAID
12-Month Postpartum Period
 Not pregnant/postpartum 1765 3843.0 45.9 1.0 (ref) 876 1740.3 50.3 1.0 (ref)
 Pregnancy 64 123.4 51.9 1.35 (0.92, 1.81) 76 97.3 78.1 1.59 (1.17, 2.09)
 12-months postpartum 100 212.2 47.1 1.13 (0.88, 1.44) 70 158.7 44.1 0.91 (0.64, 1.20)
3-Month Postpartum Period
 Not pregnant/postpartum 1834 3967.3 46.2 1.0 (ref) 914 1819.0 50.2 1.0 (ref)
 Pregnancy 64 123.4 51.9 1.32 (0.91, 1.79) 76 97.3 78.1 1.61 (1.20, 2.10)
 3-months postpartum 31 51.6 60.1 1.53 (0.96, 2.25) 32 44.0 72.7 1.45 (0.87, 2.11)
A

To test whether effects were similar for hydroxychloroquine (HCQ) users and non-users, an interaction term between each medication with the exposure was included in the model. Effect measure modification was determined by likelihood ratio test (α=0.20).

B

Estimated by stratified Cox model, a conditional model that does not assume independence of multiple events of flares and allows different baseline hazards based on the number of previous flares a patient experienced

C

Flare defined as change in ≥1 from PGA score at previous visit

D

Flare defined as change in ≥4 from SELENA-SLEDAI score at previous visit

CI: confidence interval; HCQ: hydroxychloroquine; HR: hazard ratio; PGA: Physician Global Assessment of disease activity; PY: person-years; SLE: systemic lupus erythematosus; SLEDAI: SLE Disease Activity Index