NYU Grossman School of Medicine New York, NY, United States
Peter Izmirly1, Mala Masson2, Michael Marmor3, Noel Zahr4, Nathalie Costedoat-Chalumeau5 and Jill Buyon1, 1NYU Grossman School of Medicine, New York, NY, 2NYU Langone Medical Center- Division of Rheumatology, New York, NY, 3Stanford University, Stanford, CA, 4Pitié-Salpêtrière Hospital, Paris, France, 5Inserm DR Paris 5, Paris, France
Background/Purpose: The preventive approach to congenital heart block with hydroxychloroquine (HCQ) [PATCH] study supported the efficacy of HCQ to reduce the recurrence rate of cardiac disease. This study considered whether the drug had any effects upon the retinal development of these children, examined 5 years later.
Methods: Mothers in the PATCH study were treated with HCQ 400mg daily from 10 weeks of gestation and maintained throughout pregnancy. To assess maternal compliance, whole blood HCQ levels were measured using high performance liquid chromatography at baseline, second trimester, third trimester, delivery and cord blood. At age 5, ocular coherence tomography (OCT) was performed (CIRRUS HD-OCT,Carl Zeiss Meditec) on 10 HCQ children and 16 age, gender, racial/ethnically matched controls. Cross-sectional images were examined while blinded to exposure history, and retinal thickness values were recorded from the 9 Early Treatment Diabetic Retinopathy Study (ETDRS) regions. Standard deviations and Mann-Whitney analyses were obtained.
Results: The mean gestational age at birth of the mothers on HCQ was 37.5 compared to 37.7 in the controls. Cord and blood levels were quite variable between visits and subjects, ranging from 50-1349 ng/ml. OCT cross sections were of good quality in all cases and showed a completely normal appearance. The ETDRS thickness values showed typical normal variability within both control and treated groups, with no major outliers. The overall thickness averaged 295.7 µ in controls compared to 285.8 µ in HCQ cases. The treated eyes did not show any consistent regional loss of thickness and were slightly thinner in all 9 ETDRS regions. Statistical analysis was of limited value because of normal variability and the small sample, but no obvious discrepancies were noted.
Conclusion: The study data confirmed maternal adherence and the transplacental passage of HCQ. OCT anatomy was normal at 5 years of age in treated eyes. There is significant variation among ETDRS thickness values in normal adults, while no norms are established for children. Between small patient cohorts, a variation of 10 µ in average thickness would not be clinically significant. Thus, these OCT data show macular thickness to be slightly thinner in HCQ exposed children, but probably within clinical variation for normative samples and without any change in retinal morphology in OCT cross-sections. They provide reassurance that the use of HCQ In pregnancy does not cause obvious damage or developmental loss in the children of mothers given HCQ during pregnancy.
Disclosures: P. Izmirly, Momenta/Janssen; M. Masson, None; M. Marmor, None; N. Zahr, None; N. Costedoat-Chalumeau, UCB, Roche; J. Buyon, Equillium, GlaxoSmithKlein(GSK), L and M Healthcare Communications, Janssen, Boomcom, Merck/MSD.