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Safety and efficacy of low-dose intravenous arsenic trioxide in systemic lupus erythematosus: an open-label phase IIa trial (Lupsenic)
- Source :
- Arthritis Research & Therapy, Arthritis Research & Therapy, 2021, 23 (1), pp.70. ⟨10.1186/s13075-021-02454-6⟩, Arthritis Research & Therapy, BMC, 2021, 23 (1), pp.70. ⟨10.1186/s13075-021-02454-6⟩, Arthritis Research & Therapy, Vol 23, Iss 1, Pp 1-11 (2021)
- Publication Year :
- 2021
- Publisher :
- Springer Science and Business Media LLC, 2021.
-
Abstract
- Background 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. Methods 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, we collected long-term data for safety and attainment of lupus low disease activity state (LLDAS). Results Four serious AEs occurred (grade 3 neutropenia, osteitis, neuropathy), 2 of which were attributable to ATO (neutropenia in the 2 patients treated with mycophenolate). Two patients suffered a severe flare during the last 4 weeks of the trial. At W24, five 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 (P Conclusions A short course of ATO has an acceptable safety profile in SLE patients and encouraging efficacy. Trial registration ClinicalTrials.gov, NCT01738360 registered 30 November 2012
- Subjects :
- Adult
0301 basic medicine
medicine.medical_specialty
lcsh:Diseases of the musculoskeletal system
medicine.drug_class
Autoimmune diseases
[SDV]Life Sciences [q-bio]
Neutropenia
Antibodies, Monoclonal, Humanized
Severity of Illness Index
03 medical and health sciences
chemistry.chemical_compound
Systemic lupus erythematosus
0302 clinical medicine
Arsenic trioxide
Internal medicine
Clinical endpoint
Humans
Lupus Erythematosus, Systemic
Medicine
Adverse effect
030203 arthritis & rheumatology
business.industry
medicine.disease
Phase II clinical trial
Rheumatology
3. Good health
[SDV] Life Sciences [q-bio]
Treatment
Treatment Outcome
030104 developmental biology
chemistry
Corticosteroid
lcsh:RC925-935
Osteitis
business
Immunosuppressive Agents
Research Article
Subjects
Details
- ISSN :
- 14786362
- Volume :
- 23
- Database :
- OpenAIRE
- Journal :
- Arthritis Research & Therapy
- Accession number :
- edsair.doi.dedup.....3d783b20de2850c9ff99528eb2edaa9a