Background Belimumab is a monoclonal antibody, inhibitor of soluble B-cell activating factor, that is used in the adjuvant treatment of adult patients with active seropositive systemic lupus erythematosus (SLE) . Belimumab was approved in Poland in 2011.
Objectives To analyze the influence of belimumab therapy on the severity of SLE (expressed as SLEDAI score) and glucocorticoid (GC) use in Polish patients qualified to Early Access Program (EAP).
Methods Recruitment to EAP was started in April 2012 in 8 Polish tertiary rheumatology centers. A total of 23 subjects were enrolled. The data of 22 patients (mean age 38.5±8.7 years, 18 women) with at least 3-month follow-up were analyzed. Median time elapsed between the diagnosis of SLE and the enrollment was 7 years (range: 1-39 years). Median SLEDAI score at baseline equaled 13.5 points (range: 6-32 points), and median baseline prednisone equivalent amounted to 11 mg (range: 5-35 mg).
Results Median SLEDAI score at 3 months (7 points, range: 3-14 points) was significantly lower than the respective baseline value (p<0.001). Moreover, a significant decrease in the median GC use was documented after 3 months of the treatment (down to 8 mg, range: 2-35 mg; p=0.033). The dose of GCs was reduced in 12/22 patients (median reduction: 33%, range: 17-67%). 13/22 patients continued therapy with belimumab for at least 12 months after the enrollment. Both median SLEDAI score (4 points, range: 0-13 points) and median GCs dose (7.5 mg, range: 0-40 mg) at 12 months were significantly lower than the respective baseline values (p=0.002 and p=0.033, respectively). The treatment was stopped in 4 cases due to remission (n=2) or other causes (surgery, pregnancy plans, n=2), or withdrawn due to its inefficacy (n=3), IgA deficit/leukopenia and infection (n=2).
Conclusions The obtained results point to the efficacy of belimumab in the management of SLE. Our findings are similar to those documented in the BLISS trial .
Ginzler EM, Wallace DJ, Merrill JT, et al. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2013 [Epub ahead of print].
van Vollenhoven RF, Petri MA, Cervera R, et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343-9.
Acknowledgements GlaxoSmithKline provided support for data analysis.
Disclosure of Interest None declared