Which Patients Respond Best to Belimumab?
van Vollenhoven RF, Petri MA, Cervera R, et al
Ann Rheum Dis. 2012 Feb 15 [Epub ahead of print]
Belimumab has recently been approved in the United States for treatment of systemic lupus erythematosus (SLE), with a specific indication for use in adult patients with active, autoantibody-positive disease who are currently receiving standard therapies. However, the optimal use of this agent in SLE has not been well defined.
In this study, van Vollenhoven and colleagues used pooled data from 2 randomized, placebo-controlled clinical trials of 1684 patients with SLE (all antinuclear antibody- or anti-dsDNA-positive) to evaluate the factors that predict response to belimumab therapy. All patients were treated with standard therapies, including steroids, hydroxychloroquine, and/or immunosuppressive agents, in conjunction with belimumab or placebo. The primary outcome was improvement in the SLE Responder Index (SRI), a composite measure of disease activity developed for use in clinical trials of belimumab.
In several types of analyses, including univariate analysis and analysis of patients grouped according to disease activity, the investigators found that predictors of an improved SRI at week 52 in response to belimumab included high disease activity at baseline defined by SELENA-SLEDAI scores ≥10, low complement levels, elevated anti-dsDNA levels, and steroid use. In addition to improvements in the SRI, belimumab was associated with reduced risk for SLE flares, improved measures of health-related quality of life, and reduced use of steroids. The investigators concluded that belimumab, especially at 10 mg/kg, had greater therapeutic benefit than standard therapy in patients with higher disease activity at baseline.
Belimumab in the Treatment of Systemic Lupus Erythematosus: High Disease Activity Predictors of Response
van Vollenhoven RF, Petri MA, Cervera R, et al
Ann Rheum Dis. 2012 Feb 15 [Epub ahead of print]
Study Summary
Belimumab has recently been approved in the United States for treatment of systemic lupus erythematosus (SLE), with a specific indication for use in adult patients with active, autoantibody-positive disease who are currently receiving standard therapies. However, the optimal use of this agent in SLE has not been well defined.
In this study, van Vollenhoven and colleagues used pooled data from 2 randomized, placebo-controlled clinical trials of 1684 patients with SLE (all antinuclear antibody- or anti-dsDNA-positive) to evaluate the factors that predict response to belimumab therapy. All patients were treated with standard therapies, including steroids, hydroxychloroquine, and/or immunosuppressive agents, in conjunction with belimumab or placebo. The primary outcome was improvement in the SLE Responder Index (SRI), a composite measure of disease activity developed for use in clinical trials of belimumab.
In several types of analyses, including univariate analysis and analysis of patients grouped according to disease activity, the investigators found that predictors of an improved SRI at week 52 in response to belimumab included high disease activity at baseline defined by SELENA-SLEDAI scores ≥10, low complement levels, elevated anti-dsDNA levels, and steroid use. In addition to improvements in the SRI, belimumab was associated with reduced risk for SLE flares, improved measures of health-related quality of life, and reduced use of steroids. The investigators concluded that belimumab, especially at 10 mg/kg, had greater therapeutic benefit than standard therapy in patients with higher disease activity at baseline.
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