Research Article

Health Technology Assessment of Belimumab: A New Monoclonal Antibody for the Treatment of Systemic Lupus Erythematosus

Table 2

Main characteristics and results of the randomized controlled trials on belimumab.

Study name (phase)Study designStudy populationMain results

LBSL02 (Phase II) [41]Randomized, double blinded, controlled (belimumab 10 mg/kg + SoC versus belimumab 4 mg/kg + SoC versus belimumab 1 mg/kg + SoC versus placebo + SoC)449 adult subjects with positive antibodies or positive antibodies history and SELENA SLEDAI flare index ≥ 4 from Canada and USNo significant differences in improvement of the SELENA SLEDAI flare index by week 24 and no significant differences in the occurrence of flares by week 52. Evidence of a greater benefit from belimumab in patients currently positive for autoantibodies

C1056/BLISS-76 (Phase III) [42]Randomized, double blinded, controlled (belimumab 10 mg/kg + SoC versus belimumab 1 mg/kg + SoC versus placebo + SoC)819 adult subjects with positive antibodies and SELENA SLEDAI flare index ≥ 6 from 19 countries (Europe and North America)Response at week 52: 43% in the 10 mg/kg belimumab group versus 34% in placebo group, . Belimumab reduced the number of severe flares (21% in the 10 mg/kg belimumab group compared to 27% in placebo group, )

C1057 BLISS-52 (Phase III) [43]Randomized, double blinded, controlled (belimumab 10 mg/kg + SoC versus belimumab 1 mg/kg + SoC versus placebo + SoC)865 adult subjects with positive antibodies and SELENA SLEDAI flare index ≥ 6 from 13 countries (East Europe, Asia, and South America) Response at week 52: 58% in the 10 mg/kg belimumab group versus 44% in placebo group, . Belimumab significantly reduced the number of severe flares (14% in the 10 mg/kg group compared to 23% in placebo group, ). Belimumab allowed a greater number of patients to reduce the prednisone dosage below 7.5 mg/die (19% in the 10 mg/kg group compared to 12% in placebo group, )