The ILLUMINATE trial involved 1,124 patients with moderate-to-severe SLE who received standard care plus either placebo or the human IgG4 antibody tabalumab, which targets B-cell activating factor (BAFF). This trial met its primary end point—a significant difference versus placebo in the proportion of patients achieving an SLE Responder Index 5 (SRI-5) response at week 52—in the group receiving 120 mg subcutaneous tabalumab every 2 weeks (38.4% versus 27.7%; P = 0.002), although not in those receiving once-monthly dosing.
References
Merrill, J.T. et al. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann. Rheum. Dis. doi:10.1136/annrheumdis-2015-207654
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Favourable phase III results for BAFF-blocker tabalumab. Nat Rev Rheumatol 11, 562 (2015). https://doi.org/10.1038/nrrheum.2015.123
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DOI: https://doi.org/10.1038/nrrheum.2015.123