Development and preselection of criteria for short term improvement after anti-TNFα treatment in ankylosing spondylitis

• DOI: 10.1136/ard.2003.016717
• Publication Date: 2004-03-30T01:33:51Z
• Authors: J Brandt; J Listing; J Sieper; M Rudwaleit; D van der Heijde; J Braun
• Keywords: Adult; Male; Chi-Square Distribution; Tumor Necrosis Factor-alpha; Antibodies, Monoclonal; Middle Aged; Infliximab; Receptors, Tumor Necrosis Factor; Etanercept; 3. Good health; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Data Interpretation, Statistical; Immunoglobulin G; Humans; Female; Spondylitis, Ankylosing; Randomized Controlled Trials as Topic

<b>Objective:</b> To develop and compare candidate improvement criteria for anti-TNFα treatment in ankylosing spondylitis with optimal discriminating capacity between placebo. <b>Methods:</b> Data from two randomised controlled trials which included 99 patients treated infliximab or etanercept were used to evaluate 50 criteria. These developed on the basis of pain, patient’s global assessment, function, morning stiffness, spinal mobility, C reactive protein. Different levels each domain (20–60%) define Boolean type compared different percentages BASDAI modified ASAS Bootstrap methods applied calculate 95% confidence intervals (CI) χ² test values select best <b>Results:</b> The performing “20% five six domains” (χ² = 31.9 (95% CI, 18.0 46.9)) a low placebo response 2.9% high 67.7%; “ASAS 40% improvement” 26.5 (13.3 41.1)), 5.7% 64.7%. good was confirmed by combined dataset trial. <b>Conclusions:</b> “five six” criterion has advantage including objective domains <i>spinal mobility</i> <i>acute phase reactants</i>, but requires only 20% improvement. setting threshold, patient reported outcomes. choice these needs be based further validation upcoming trials.