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Improvement in health-related quality of life in systemic lupus erythematosus patients enrolled in a randomized clinical trial comparing LJP 394 treatment with placebo
V Strand
Division of Immunology, Stanford University, Palo Alto, CA, USA, vstrand{at}aol.com
C Aranow
Department of Medicine, New York Medical College, Valhalla, USA
M H Cardiel
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico
D Alarcón-Segovia
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico
R Furie
Division of Rheumatology and Allergy-Clinical Immunology, North Shore University Hospital, Manhasset, NY, USA
Y Sherrer
Center for Rheumatology, Immunology and Arthritis Research, Ft Lauderadale, FL, USA
J Tumlin
Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA
D J Wallace
Division of Rheumatology, Department of Medicine, Cedars-Sinai Medical Center, UCLA School of Medicine, Los Angeles, CA, USA
LJP 394 Investigator Consortium
B Crawford
MAPI Values USA, Boston, MA, USA
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 in RE domain scores following a flare differed by 22.7 points between the two treatment groups, favouring LJP 394 treatment.
Patients receiving LJP 394 reported stable or improved HRQOL with active treatment following renal flares compared with deterioration in placebo. Differences between treatment groups in RE and SF domains are clinically important and were replicated irrespective of the protocol population analysed.
Key Words: anti-dsDNA antibodies • health-related quality of life • SF-36 • SLE
Lupus, Vol. 12, No. 9,
677-686 (2003)
DOI: 10.1191/0961203303lu440oa
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