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Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus
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Wallace, DJ (author)
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Navarra, S (author)
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Petri, MA (author)
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Gallacher, A (author)
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Thomas, M (author)
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Furie, R (author)
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Levy, RA (author)
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- van Vollenhoven, RF (author)
- Karolinska Institutet
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Cooper, S (author)
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Zhong, ZJ (author)
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Freimuth, W (author)
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Cervera, R (author)
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(creator_code:org_t)
- 2012-12-04
- English.
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In: Lupus. - : SAGE Publications. - 1477-0962 .- 0961-2033. ; 22:2, s. 144-154
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https://doi.org/10.1...
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Abstract
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- Safety data were pooled and analyzed from one phase 2 and two phase 3 double-blind, placebo-controlled, repeat-dose systemic lupus erythematosus (SLE) trials of belimumab 1, 4 (phase 2 only), and 10 mg/kg. Types and rates of adverse events (AEs) were similar across treatment groups. Rates of patients experiencing any serious AE were 16.6%, 19.5%, 13.5%, and 18.0% with placebo, and belimumab 1, 4, and 10 mg/kg, respectively; rates of serious infusion reactions (including hypersensitivity reactions) occurring on the same days as infusions were 0.4%, 0.9%, 0%, and 0.9%, and rates of serious infections were 5.5%, 7.1%, 6.3%, and 5.3%. Malignancy rates/100 patient-years (excluding non-melanoma skin cancer) were 0.29 with placebo vs. 0.20 with all belimumab doses combined; mortality rates/100 patient-years were 0.43 vs. 0.73. These data support the conclusion that belimumab in combination with standard SLE therapy was generally well tolerated in a predominantly autoantibody-positive population with active SLE. ClinicalTrials.gov identifiers: LBSL02: NCT00071487; BLISS-52: NCT00424476; BLISS-76: NCT00410384.
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