Low-dose Intravenous Arsenic Trioxide is safe and efficient
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Lupus animal model has shown that arsenic trioxide (ATO), a treatment of acute promyelocytic leukaemia, could be effective in SLE. This is the first clinical study to determine the safety and efficacy of a short course of intravenous ATO in patients with active SLE.

This phase IIa, open-label, dose-escalating study enrolled 11 adult SLE patients with a non-organ threatening disease, clinically active despite conventional therapy. Patients received 10 IV infusions of ATO within 24 days. The first group received 0.10 mg/kg per injection, with dose-escalating to 0.15 mg/kg in a second group, and to 0.20 mg/kg in a third group. The primary endpoint was the occurrence of adverse events (AEs) and secondary endpoints were the number of SLE Responder Index 4 (SRI-4) responders at week 24 and reduction of corticosteroid dosage. In an exploratory analysis, long-term data was collected for safety and attainment of lupus low disease activity state (LLDAS).

Results:
--4 serious AEs occurred (grade 3 neutropenia, osteitis, neuropathy), 2 of which were attributable to ATO (neutropenia in the 2 patients treated with mycophenolate).

--2 patients suffered a severe flare during the last 4 weeks of the trial. At W24, 5 patients among 10 were SRI-4 responders.

--Overall, mean corticosteroid dosage decreased from 11.25 mg/day at baseline to 6 mg/day at W24.

--In the long term, 6 patients attained LLDAS at W52, which continued at last follow-up (median LLDAS duration 3 years, range 2–4).

In conclusion, a short arsenic trioxide course has a reasonable safety and efficacy profile in SLE patients.

Source: https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-021-02454-6
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