Several research teams at the New York University School of Medicine – Langone Medical Center recently presented their latest discoveries on key clinical aspects of Systemic Lupus Erythematosus at the NYU Seminar in Advanced Rheumatology.
In a study entitled Preventive Approach to Congenital Heart Block with Hydroxychloroquine (PATCH) and financed under the 2014 LIFELINE Grant Program from the Lupus Foundation of America (a program launched under the Foundations’ National Research Program to support lupus research to faculty groups who have experienced a gap in external funding) researchers presented their preliminary findings on how Hydroxychloroquine, an anti-malarial drug, can be used to prevent congenital heart block in children born from women with systemic lupus erythematosus.
PATCH is a two-phase study, led by Jill P. Buyon, New York University School of Medicine, where pregnant women (maximum gestation of 10 weeks), positive for anti-Ro-positive antibodies (often found in lupus cases) were treated with hydroxychloroquine at 400 mg/day. The treatment resulted in fewer fetuses developing second or third degree heart block, with preliminary results suggesting the treatment has beneficial effects. The PATCH study is ongoing and currently recruiting participants for its Phase 2 (please read additional information here).
The ultimate goal is to perform a screening and prevention trial, by enrolling 550,000 women which will be followed during 3 years and screened for anti-Ro antibodies. Antibody-positive women could then participate in a randomized study to receive either hydroxychloroquine or placebo and thus determine the decrease in risk of congenital heart block.
Another study, entitled Predictors of Pregnancy Outcome: BioMarkers In Antiphospholipid Syndrome and Systemic Lupus Erythematosus (PROMISSE) was also presented during the same session. The PROMISSE study was a multicenter observational study conducted over 10 years (it began in 2003) to identify risk factors and predictors of adverse pregnancy outcomes in pregnant women with systemic lupus erythematosus (the study enrolled 389 patients). The trial was lead by principal investigator Jane Salmon, MD at the Hospital for Special Surgery, New York and recipient of the Foundation’s Evelyn V. Hess Award. The teams’ findings will help clinicians to manage pregnant patients who suffer with lupus.