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

Abstract

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 neuro-ophthalmological 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.

Pregnancy and menopause in patients with Systemic Lupus Erythematosus and/or Antiphospholipid Syndrome: practical guide from EULAR

“…48 In addition, there are data suggesting that the use of HCQ during pregnancy might reduce the risk of CHB, 49 especially in subsequent pregnancies of women with a previous child with CHB. 50 The protective role of HCQ in pregnant women with aPL antibody positivity is controversial due to its anti-inflammatory, antiaggregant, and immunoregulatory properties, 51 and future prospective studies are necessary to clarify whether HCQ should be routinely recommended in clinical practice for women positive for aPL antibodies.…”

Gravidez, Aleitamento e Fármacos em Dermatologia - Tratamento Sistémico

“…Os estudos publicados não identificaram qualquer aumento no risco de malformações congénitas ou toxicidade retiniana. [108][109][110][111][112][113] De acordo com o consenso da EULAR, a administração da hidroxicloroquina pode ser continuada durante toda a gestação. 5 A utilização de hidroxicloroquina parece segura durante a amamentação, verificando-se uma exposição mínima do lactente através do leite materno.…”

New treatment strategy including biological agents in patients with systemic lupus erythematosus

“…Both drugs may be used during pregnancy and lactation. 11, [18][19][20][21][22][23] Rheumatologists and ophthalmologists have raised concerns about possible toxic effects of antimalarials, particularly on the retina. However, in 4 clinical studies including 647 patients treated with CQ for over 10 years, toxic effects on there is a high risk of successive flare-ups.…”