Improvement in health-related quality of life in systemic lupus erythematosus patients enrolled in a randomized clinical trial comparing LJP 394 treatment with placebo.

In a 76-week, randomized controlled trial, patients received 100mg LJP 394 or placebo weekly for 16 weeks followed by three 12-week treatment cycles of 50mg LJP 394 or placeboweekly each separated by eight-week periods when no therapy was administered.Health-relatedquality of life (HRQOL) was assessed using SF-36 at baseline, 16 weeks and every 12 weeks thereafter. Analyses populations included intent to treat (ITT) (n 179) and patients with high-affinity anti-dsDNA antibody binding (HA): 157/179; 85% active, 90% placebo. In the ITT population, there were improvements in role emotional (RE) (7.3 versus - 8.2), social functioning (SF) (4.3 versus 0.7), and role physical (RP) (11.3 versus 6.0) domains in the active treatment group when compared with placebo, with similar changes observed in the HA population. In 37 patients with data pre- and post-renal flares, those receiving LJP 394 reported stabilization or improvement in all but one domain compared with deterioration in all domains with placebo. Changes...