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Hydroxychloroquine (HCQ) in lupus pregnancy: double-blind and placebo-controlled study

Department of Rheumatology, Faculdade de Ciências Médicas, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil; Hospital Universitário Pedro Ernesto, UERJ, Discipline of Rheumatology, Blvd 28 de Setembro 77/333, Vila Isabel 20550-013, Rio de Janeiro, RJ, Brazil rlevy{at}uerj.br

V S Vilela

M J Cataldo

Department of Rheumatology, Faculdade de Ciências Médicas, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

R C Ramos

Department of Ophthalmology, Faculdade de Ciências Médicas, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

J LMB Duarte

Department of Pediatrics, Faculdade de Ciêdicas, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

B R Tura

Department of Medical Informatics, Faculdade de Ciências Méncias, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

E MN Albuquerque

Department of Rheumatology, Faculdade de Ciências Médicas, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

N R Jesús

Department of Obstetrics, Faculdade de Ciências Médicas, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

We conducted a randomized, controlled study to assess the need for hydroxychloroquine (HCQ) during lupus pregnancy and to assess safety. Twenty consecutive pregnant patients with similar characteristics were enrolled. The HCQ group included eight patients with systemic lupus erythematosus (SLE) and two with discoid lupus erythematosus (DLE). The placebo (PL) group included nine patients with SLE and one with DLE. The HCQ group had no flare-ups. SLEPDAI scores were similar at study entry, and at conclusion the placebo group had significantly higher scores. One patient had improvement of skin lesions and another of arthritis, allowing a decrease of prednisone dose. There were no retinal effects. Three patients in the PL group flared up, two with skin rashes, one also with arthritis and uveitis, and one (previously in remission on HCQ) with hemolytic anemia, polyserositis and anti-dsDNA antibody. Toxemia was diagnosed in only three patients in the PL group (one fetal death). Comparing prednisone dosage change, we noted a decrease in the HCQ and an increase in the PL group. Delivery age and Apgar scores were higher in the HCQ group. Neonatal examination did not reveal congenital abnormalities, nor did a neuroophthalmological and auditory evaluation at 1.5–3 y of age. In spite of the small number of patients studied, we noted beneficial effects of HCQ during lupus pregnancy, as measured by SLEPDAI and decrease in prednisone dose with no detriment to patients' health.

Key Words: lupus pregnancy • antimalarials • hydroxychloroquine

Lupus, Vol. 10, No. 6, 401-404 (2001)
DOI: 10.1191/096120301678646137


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