(HealthDay News) – Some patients with antiphospholipid syndrome with non-criteria manifestations may improve after treatment with rituximab, according to a study published online Nov. 2 in Arthritis & Rheumatism.
As part of a Phase 2 trial, Doruk Erkan, MD, from the Hospital for Special Surgery in New York City, and colleagues treated 19 patients with two doses of rituximab (1,000mg) on Days One and 15. The patients were positive for antiphospholipid antibody (aPL) and had antiphospholipid syndrome with non-criteria manifestations (thrombocytopenia, cardiac valve disease, aPL-nephropathy, skin ulcer, and/or cognitive dysfunction).
At 24 weeks, the researchers found that, of the four patients with thrombocytopenia, one had a complete response and one had a partial response. Of the three patients with cardiac valve disease, none responded. Of the five patients with skin ulcer, three had a complete response and one had a partial response. The one patient with aPL-nephropathy had a partial response. Of the five patients with cognitive dysfunction, three had a complete response and one had a partial response. There was no change in aPL profiles. Two patients developed infusion reactions and were terminated early, and there were 12 serious and 49 non-serious adverse events.
“Our uncontrolled and non-randomized pilot study suggests that safety is consistent with rituximab’s safety profile in aPL-positive patients; and despite no substantial change in aPL profiles, rituximab may be effective in controlling some but not all non-criteria aPL manifestations,” Erkan and colleagues conclude.
The laboratory tests and study medication were paid for by Genentech. One author disclosed a financial relationship with Genentech.