Table 1. Recent SLE randomized, controlled trials of biologics.
Reference | Size | Study drug | Endpoint | Select findings |
---|---|---|---|---|
Merrill et al. [21] | 257 | Rituximab | BILAG MCR/PCR* at 52 weeks | No significant difference in primary and secondary endpoints; subgroup analysis suggests benefit in black and Hispanic subjects |
Merrill et al. [22] | 180 | Abatacept | BILAG flare by 1 year | No significant difference in primary and secondary endpoints; post hoc subgroup analysis suggests higher fraction of treated subjects on low dose prednisone without flare during final 2 months of study |
Chatham et al. [23] | 449 | Belimumab | SELENA-SLEDAI at 52 weeks | No significant difference in primary and secondary endpoints; post hoc subgroup analysis suggests benefit in seropositive subjects as measured by novel SLE responder index |
*MCR = all BILAG Cs or better in every organ system at 24 weeks with maintenance of this response until week 52; PCR = all BILAG Cs or better at week 24 and maintenance for 16 weeks or at most 1 BILAG B at week 24 and maintenance until week 52. BILAG, British Isles Lupus Assessment Group; MCR, major clinical response; PCR, partial clinical response; SELENA, Safety of Estrogen in Lupus Erythematosus National Assessment; SLE, systemic lupus erythematosus; SLEDAI, SLE Disease Activity Index.