Patients with systemic lupus erythematosus (SLE) frequently require corticosteroids as standard therapy. One question that remains is whether treatment with belimumab facilitates a tapering of or the discontinuation of corticosteroid therapy. This has been a controversial issue in 2 presentations at the 2013 annual meeting of the American College of Rheumatology held in San Diego, California from October 25-30, showing evidence that belimumab does (Abstract 1740) and does not (Abstract 1605) enable discontinuation of corticosteroid therapy in patients with SLE.
In another report presented by van Vollenhoven and colleagues (Abstract 1585), pooled data were analyzed from the BLISS-52 and BLISS-76 trials, which assessed the effects of treatment with belimumab on corticosteroid dosing across 52 weeks.
In the 2 BLISS studies, patients treated with corticosteroids at baseline were randomized to receive belimumab 10 mg/kg plus standard therapy (N = 478) or placebo plus standard therapy (N = 488). The patients in the 2 BLISS trials had active SLE (ie, SLELNA-SLEDAI scores of >6), and were 94% female, with a mean age of 37.1 years and a mean daily corticosteroid dose of 12.5 mg.
Based on the pooled data from these studies, the mean of all cumulative decreases in corticosteroid dose was 741 mg in the belimumab group versus 542 mg in the placebo group (P = .017). The mean of all cumulative increases in corticosteroid dose was 1272 mg in the belimumab group versus 1458 mg in the placebo group (P <.001). The mean cumulative change from baseline in corticosteroid dose was 531 mg in the belimumab group versus 916 mg in the placebo group (P <.001). The mean change from baseline in average daily corticosteroid dose was 1.46 mg in the belimumab group and 2.51 mg in the placebo group (P <.001).
Therefore, although there was an increase in total corticosteroid dose in the belimumab and in the placebo groups over the 52-week duration of the BLISS trials, the increase was significantly smaller in patients who received belimumab plus standard therapy than in patients receiving standard therapy alone.
These results underscore the fact that for patients with moderately active SLE, long-term corticosteroid use is not only a reality but also a major determinant of long-term clinical outcome. However, patients with SLE who are receiving belimumab are able to significantly lower their requirements for increased corticosteroid dose compared with patients who receive placebo, which may have a significant clinical relevance. It will be interesting to follow the postmarketing experience with belimumab to see if these positive effects on corticosteroid dose requirements are replicated in routine clinical practice in academic lupus centers or in community rheumatology offices.