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Objective  To evaluate the safety and potential efficacy of  AMG  557, a fully human antibody directed against the inducible T cell costimulator ligand (ICOSL) in patients with systemic lupus erythematosus ( SLE ) with arthritis.    Methods  In this phase Ib, randomized, double‐blind, placebo‐controlled study, patients received  AMG  557 210 mg (n = 10) or placebo (n = 10) weekly for 3 weeks, then every other week for 10 additional doses. The corticosteroid dosage was tapered to ≤7.5 mg/day by day 85, and immunosuppressants were discontinued by day 29. Primary end points on day 169 were safety, immunogenicity, the Lupus Arthritis Response Index ( LARI ; defined by a reduction in the tender and swollen joint counts), ≥1‐letter improvement in the musculoskeletal domain of the British Isles Lupus Assessment Group ( BILAG ) index, and medication discontinuation. The secondary/exploratory end points were changes in the tender and swollen joint counts,  BILAG  index scores (musculoskeletal, global), and the Systemic Lupus Erythematosus Disease Activity Index ( SLEDAI ).    Results  The incidence of adverse events, most of which were mild, was similar between groups.  LARI  responses occurred in 3 of 10 patients receiving  AMG  557 and 1 of 10 patients receiving placebo ( P =  0.58). More patients in the  AMG  557 group achieved a ≥4‐point improvement in the  SLEDAI  score on day 169 (7 of 10 patients) compared with the placebo group (2 of 10 patients) ( P =  0.07). Patients treated with  AMG  557 (versus placebo) had greater improvements from baseline in the global  BILAG  index scores (–36.3% versus –24.7%) and the  SLEDAI  score (–47.8% versus –10.7%) and in tender (–22.8% versus –13.5%) and swollen (–62.1% versus –7.8%) joint counts on day 169.    Conclusion   AMG  557 showed safety and potential efficacy, supporting further evaluation of the clinical efficacy of  ICOSL  blockade in patients with  SLE .

arthritis and rheumatology

Brief Report: A Randomized, Double‐Blind, Parallel‐Group, Placebo‐Controlled, Multiple‐Dose Study to Evaluate  AMG  557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis