Table 1

Points to consider in using belimumab and rituximab in patients with SLE55–57 59 60 66 68–71

Main indications
  • New-onset or persistently active (smouldering) disease in spite of SoC treatment (usually including combination of HCQ, glucocorticoids and immunosuppressive agent(s))

  • Inability to taper glucocorticoids to <7.5 mg/day (prednisone equivalent) within 3–6 months of SoC treatment

  • Frequent relapses (at least one per year) in spite of SoC treatment

  • Active, organ-threatening disease refractory to immunosuppressive treatments (including cyclophosphamide)

Manifestations more likely to respond
  • Arthritis, mucocutaneous, cutaneous vasculitis, immunological activity

  • No evidence for severe, organ/life-threatening manifestations; may be considered to maintain the response (induced by other immunosuppressive/biological agents) and prevent relapses, as a steroid-sparing agent, to control residual/additional SLE activity

  • Arthritis (‘rhupus’), vasculitis (including visceral vasculitis), neuropsychiatric, nephritis, thrombocytopenia, autoimmune haemolytic anaemia

Predictors of response
  • Higher responses: polyarthritis, high disease activity (SLEDAI ≥10), increased anti-dsDNA

  • Lower responses: smoking, organ damage accrual

  • Higher responses: polyarthritis, thrombocytopenia, autoimmune haemolytic anaemia, increased anti-dsDNA

  • Lower responses: discoid skin lupus, mixed class V+III/IV nephritis

Assessment of response
  • Gradual response starting at 8 weeks; 40%–50% will achieve clinically significant improvement (ie, reduction in SLEDAI by ≥ 4; reduction in PGA by ≥ 1) by 4–6 months

  • Some patients with modest response at 6 months might improve further until 12 months

  • Flares can occur especially during the first year of treatment

  • Treatment failure: (A) lack of any improvement after 6 months; (B) lack of clinically significant improvement after 12 months; (C) severe flare from major organ

  • Gradual response starting at 8 weeks; 65%–70% will achieve clinically significant improvement by 6 months

  • Some patients (including nephritis cases) with partial response at 6 months may improve further until 12 months

  • Flares can occur (25%–40% after single treatment cycle)

  • Consider repeated (every 6 months) treatment cycles in severe refractory cases or cases with partial/incomplete response after first cycle

  • Monitoring circulating B cells may be useful but is not routinely performed

  • HCQ, hydroxychloroquine; PGA, physician global assessment; SLEDAI, SLE Disease Activity Index; SoC, standard of care.