This meta-analysis evaluated the association between hydroxychloroquine use and pregnancy outcomes in women with systemic lupus erythematosus (SLE). The analysis included data from multiple studies, with a sample size of 1145 for the pre-eclampsia outcome. The comparator was no hydroxychloroquine use.
Key findings showed no statistically significant differences for several outcomes: pre-eclampsia (OR=1.11, 95% CI 0.60-2.06, P>0.05), miscarriage (OR=1.27, 95% CI 0.72-2.25, P>0.05), hypertensive disorders of pregnancy (OR=0.70, 95% CI 0.09-5.65, P>0.05), and preterm delivery (OR=0.78, 95% CI 0.44-1.39, P>0.05). However, hydroxychloroquine was associated with a statistically significant lower risk of fetal growth restriction (OR=0.41, 95% CI 0.18-0.93, P<0.05) and gestational diabetes mellitus (OR=0.28, 95% CI 0.17-0.48, P<0.05).
The authors note a limitation: absence of parity-based stratification in the original studies. They also caution that results are inconsistent with previous primary studies and that further high-quality studies with subgroup analysis based on parity are strongly recommended. Adverse events were not reported.
Practice relevance: hydroxychloroquine administration during pregnancy could not reduce the incidence of gestational complications; close attention should be paid to adverse reactions and used carefully. These are associations, not causation.
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OBJECTIVE: To evaluate the associations between hydroxychloroquine (HCQ) use and the risks of pre-eclampsia, hypertensive disorders of pregnancy (HDP), and preterm delivery in pregnant women with systemic lupus erythematosus (SLE).
METHODS: PubMed, EMBASE, Cochrane Library, Scopus, and Web of Science were systematically searched from inception to May 30, 2024, for randomized controlled trials or observational studies investigating HCQ use in pregnant women with SLE. Study quality was assessed using the Newcastle-Ottawa Scale, and meta-analyses were performed using RevMan 5.1 software. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using random-effects or fixed-effects models as appropriate.
RESULTS: Nine studies were included in the meta-analysis. Compared with no HCQ use, HCQ use was not associated with statistically significant differences in the incidence of pre-eclampsia (4 studies, 1145 patients, OR = 1.11, 95% CI 0.60-2.06, P > 0.05), miscarriage (3 studies, 395 patients, OR = 1.27, 95% CI 0.72-2.25, P > 0.05), HDP (4 studies, 4787 patients, OR = 0.70, 95% CI 0.09-5.65, P > 0.05), or preterm delivery (9 studies, 2503 patients, OR = 0.78, 95% CI 0.44-1.39, P > 0.05). However, HCQ use was associated with a significantly lower risk of fetal growth restriction (FGR) (3 studies, 278 patients, OR = 0.41, 95% CI 0.18-0.93, P < 0.05) and gestational diabetes mellitus (GDM) (2 studies, 563 patients, OR = 0.28, 95% CI 0.17-0.48, P < 0.05).
CONCLUSIONS: This meta-analysis demonstrated that hydroxychloroquine administration during pregnancy could not reduce the incidence of gestational complications. The results are inconsistent with those of previous primary studies, which may be attributed to the absence of parity-based stratification in the original studies. Accordingly, close attention should be paid to the adverse reactions of hydroxychloroquine, which should be used carefully. Further high-quality studies with subgroup analysis based on parity are strongly recommended in the future.