Table 1

Study treatment arms

TreatmentArm A (control)Arm B (combination)Arm C (reference)
BelimumabBelimumab SC
200 mg/week for
52 weeks
Belimumab SC
200 mg/week for
52 weeks
Belimumab SC
200 mg/week plus SoC for 104 weeks
Rituximab or matched placeboOne cycle of placebo intravenously (rituximab-matched) at week 4 and week 6One cycle of rituximab intravenously 1000 mg at week 4 and week 6None
Premedication (30 min before each placebo or rituximab infusion)Methylprednisolone intravenously 100 mg or equivalent, oral antihistamine, acetaminophen or equivalentMethylprednisolone intravenously 100 mg or equivalent, oral antihistamine, acetaminophen or equivalentNone
Post week 52 therapyAntimalarials,
NSAIDs and/or corticosteroids with a prednisone equivalent dose of ≤5 mg/day
Antimalarials,
NSAIDs and/or corticosteroids with a prednisone equivalent dose of ≤5 mg/day
Continue belimumab SC
200 mg/week plus SoC*
  • *Patients in arm C are allowed to receive rescue therapy if, in the opinion of the investigator, they require additional treatment. This can include corticosteroids at >5 mg/day prednisone equivalent.

  • NSAIDs, non-steroidal anti-inflammatory drugs; SC, subcutaneous; SoC, standard of care.