
| 10.1002/art.40479
http://scihub22266oqcxt.onion/10.1002/art.40479
 C6032945!6032945!29513931
free
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Arthritis+Rheumatol 2018 ; 70 (7): 1071-6 Nephropedia Template TP
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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 #MMPMID29513931Cheng LE; Amoura Z; Cheah B; Hiepe F; Sullivan BA; Zhou L; Arnold GE; Tsuji WH; Merrill JT; Chung JBArthritis Rheumatol 2018[Jul]; 70 (7): 1071-6 PMID29513931show ga
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.�
  
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