Vibeke Strand, Cynthia Aranow, Mario H. Cardiel, D. Alarcón-Segovia, Richard Furie, Yvonne Sherrer, James Tumlin, Daniel J. Wallace for the LJP 394 Investigator Consortium, and Bruce Crawford

Study Objective: To assess health-related quality of life [HRQOL] in patients with systemic lupus erythematosus receiving LJP 394 or placebo.

Methods: In a 76 week, randomized controlled trial (RCT), patients received 100 mg LJP 394 or placebo weekly for 16 weeks [induction], followed by alternating 8 off and 12 weeks on treatment with 50 mg LJP 394 or placebo. Medical Outcomes Study 36-item Short Form (SF-36) was completed at baseline, end of induction, and every 12 weeks thereafter. Analyses included intent to treat (ITT) [n = 190], and high affinity [HA] populations: 168/190; 86% active, 90% placebo.

Results: At baseline all domains of SF-36 were decreased compared with age and gender matched US norms. In the ITT population, mean changes from baseline following induction were similar between active and placebo except Role Emotional [RE] (+7.72 vs. -8.07), Social Functioning [SF] (+4.61 vs. -0.13) and Role Physical [RP] (+8.95 vs. +5.32). Changes were similar in the HA population. Excluding patients with renal flares and/or those who received high dose corticosteroids and/or cytotoxic agents [HDCC] did not alter results. 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 with placebo. RE scores differed by 20.2 points; differences in change scores favored active treatment in all domains, ranging from 9.3 to 17.16. Results were similar excluding 5 patients receiving HDCC prior to renal flare.

Conclusions: Patients receiving LJP 394 reported improved HRQOL during induction and following renal flares compared with deterioration in placebo. Differences in change scores between treatment groups in RE and SF domains are clinically important and replicated irrespective of protocol population analyzed.

Presented at
The American College of Rheumatology
New Orleans, Louisiana
October 26, 2002