Comparative efficacy and safety of intravenous or subcutaneous belimumab in combination with standard therapy in patients with active systemic lupus erythematosus: a Bayesian network meta-analysis of randomized controlled trials.

Lupus

PubMedID: 28592201

Lee YH, Song GG. Comparative efficacy and safety of intravenous or subcutaneous belimumab in combination with standard therapy in patients with active systemic lupus erythematosus: a Bayesian network meta-analysis of randomized controlled trials. Lupus. 2017;961203317713143.
OBJECTIVE
In this study, we aimed to assess the relative efficacy and safety of intravenous (IV) or subcutaneous (SC) belimumab compared with those of placebo in patients with active systemic lupus erythematosus (SLE).

METHODS
We performed a Bayesian network meta-analysis to combine the direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of belimumab 1?mg/kg and 10?mg/kg IV administration, and belimumab 200?mg SC injection, and placebo in patients with active SLE despite having received standard therapy.

RESULTS
Five RCTs (3460 patients) met the inclusion criteria.The SLE Responder Index (SRI) response rate at week 52 was significantly higher in the belimumab 10?mg/kg group than in the placebo group (OR 2. 63, 95% CrI 2. 14-3. 23). Similarly, the SRI response rates were significantly higher in the belimumab 1?mg/kg, and belimumab 200?mg SC groups than in the placebo group (OR 2. 42, 95% CrI 1. 90-3. 09; OR 1. 71, 95% CrI 1. 27-2. 29). Ranking probability based on surface under the cumulative ranking curve (SUCRA) indicated that belimumab 10?mg/kg had the highest probability of being the best treatment for achieving the SRI response (SUCRA?=?0. 9174), followed by belimumab 1?mg/kg (SUCRA?=?0. 7338), belimumab 200?mg SC (SUCRA?=?0. 3487), and placebo (SUCRA?=?0. 0000). However, a sensitivity test by omitting one outlier study showing low SRI response rate compared with the other three studies (11% vs. 33%, 40%, 48%) showed that belimumab 200?mg SC and belimumab 10?mg/kg had the highest probability of being the best treatment for achieving the SRI response (SUCRA?=?0. 7903, SUCRA?=?0. 7456), followed by belimumab 1?mg/kg, and placebo. The number of serious adverse events (SAEs) did not differ significantly among the four treatment options.

CONCLUSIONS
Belimumab at 1 and 10?mg/kg IV and belimumab 200?mg SC in combination with standard therapy was an efficacious intervention for active SLE, and was not associated with a significant risk of SAEs.