New England- USCF index.pdf

The New England Journal of Medicine Copyr ight ? 2002 by the Massachusett s Medical Society VOLUME 346 M AY 2, 2002 NUMBER 18 N Engl J Med, Vol. 346, No. 18 · May 2, 2002 · · 1349 TREATMENT OF ANKYLOSING SPONDYLITIS BY INHIBITION OF TUMOR NECROSIS FACTOR a J ENNIFER D. G ORMAN , M.D., K ENNETH E. S ACK , M.D., AND J OHN C. D AVIS , J R ., M.D., M.P.H. A BSTRACT Background There are few effective treatments for ankylosing spondylitis, which causes substantial morbidity. Because of the central role of tumor necro- sis factor a in the spondyloarthritides, we performed a randomized, double-blind, placebo-controlled trial of etanercept, a recombinant human tumor necrosis factor receptor (p75):Fc fusion protein, in patients with ankylosing spondylitis. Methods Forty patients with active, inflammatory ankylosing spondylitis were randomly assigned to receive twice-weekly subcutaneous injections of et- anercept (25 mg) or placebo for four months. The primary end point was a composite of improvements in measures of morning stiffness, spinal pain, func- tioning, the patient’s global assessment of disease activity, and joint swelling. Patients were allowed to continue taking nonsteroidal antiinflammatory drugs, oral corticosteriods (?10 mg per day), and disease- modifying antirheumatic drugs at stable doses during the trial. Results Treatment with etanercept resulted in sig- nificant and sustained improvement. At four months, 80 percent of the patients in the etanercept group had a treatment response, as compared with 30 percent of those in the placebo group (P=0.004). Improvements over base-line values for various measures of disease activity, including morning stiffness, spinal pain, func- tioning, quality of life, enthesitis, chest expansion, erythrocyte sedimentation rate, and C-reactive protein, were significantly greater in the etanercept group. Longitudinal analysis show