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Table 1 Arsenic trioxide safety at week 24

From: Safety and efficacy of low-dose intravenous arsenic trioxide in systemic lupus erythematosus: an open-label phase IIa trial (Lupsenic)

Adverse event type

n

Total number of ATO-related AEs

22

Treatment-emergent SAEs

4

Neutropenia*

2

Axonal neuropathy†

1

Osteitis‡

1

AEs leading to ATO discontinuation

 Neutropenia grade 3

2

Treatment-related AEs (mild to moderate)

18

 Anaemia (grade 2)

2

 Diarrhoea (grade 1)

5

 Nausea

2

 Hypomagnesaemia

1

 Mild QT prolongation (grade 1)

2

 Injection-related reaction

1

 Injection site reaction

1

 Hypotension

1

 Flushing

1

 Increased transaminases (grade 1)

1

 Fatigue

1

  1. * Neutropenia in 2 patients treated respectively with 0.15 and 0.20 mg/kg of ATO associated with MMF
  2. Neuropathy associated with acute hepatitis A virus infection
  3. Osteitis of a toe in a patient with Jaccoud arthropathy
  4. AEs adverse events, SAE severe adverse event, ATO arsenic trioxide, MMF mycophenolate mofetil