Gorlier C, Orbai AM, Puyraimond-Zemmour D, Coates LC, Kiltz U, Leung YY, Palominos P, Cañete JD, Scrivo R, Balanescu A, Dernis E, Tälli S, Ruyssen-Witrand A, Soubrier M, Aydin SZ, Eder L, Gaydukova I, Lubrano E, Kalyoncu U, Richette P, Husni ME, de Wit M, Smolen JS, and Gossec L
Annals Of The Rheumatic Diseases [Ann Rheum Dis] 2019 Feb; Vol. 78 (2), pp. 201-208. Date of Electronic Publication: 2018 Nov 15.
Wevers-de K V C, Boer, L, Heimans, K, Visser, J, Kälvesten, R J, Goekoop, M, van Oosterhout, J B, Harbers, C, Bijkerk, M, Steup-Beekman, M P D M, de Buck, P B J, de Sonnaville, T W J, Huizinga, and C F, Allaart
Annals of the Rheumatic Diseases. Feb 01, 2015 74(2):341-346
Wevers-de Boer, K. V. C., Heimans, L., Visser, K., Kälvesten, J., Goekoop, R. J., van Oosterhout, M., Harbers, J. B., Bijkerk, C., Steup-Beekman, M., de Buck, M. P. D. M., de Sonnaville, P. B. J., Huizinga, T. W. J., and Allaart, C. F.
Annals of the Rheumatic Diseases; Feb2015, Vol. 74 Issue 2, p341-346, 6p, 6 Charts
Aim To assess whether in early (rheumatoid) arthritis (RA) patients, metacarpal bone mineral density (BMD) loss after 4 months predicts radiological progression after 1 year of antirheumatic treatment. Methods Metacarpal BMD was measured 4 monthly during the first year by digital X-ray radiogrammetry (DXR-BMD) in patients participating in the IMPROVED study, a clinical trial in 610 patients with recent onset RA (2010 criteria) or undifferentiated arthritis, treated according to a remission (disease activity score<1.6) steered strategy. With Sharp/van der Heijde progression >0.5 points after 1 year (yes/no) as dependent variable, univariate and multivariate logistic regression analyses were performed. Results Of 428 patients with DXR-BMD results and progression scores available, 28 (7%) had radiological progression after 1 year. Independent predictors for radiological progression were presence of baseline erosions (OR (95% CI) 6.5 (1.7 to 25)) and early DXR-BMD loss (OR (95% CI) 1.5 (1.1 to 2.0)). In 366 (86%) patients without baseline erosions, early DXR-BMD loss was the only independent predictor of progression (OR (95% CI) 2.0 (1.4 to 2.9)). Conclusions In early RA patients, metacarpal BMD loss after 4 months of treatment is an independent predictor of radiological progression after 1 year. In patients without baseline erosions, early metacarpal BMD loss is the main predictor of radiological progression. [ABSTRACT FROM AUTHOR]
Introduction: Flares may be used as outcomes in axial spondyloarthritis (axSpA) trials or observational studies. The objective was to develop a definition for 'flare' (or worsening) in axSpA, based on validated composite indices, to be used in the context of clinical trial design. Methods: (1) Systematic literature review of definitions of 'flare' in published randomised controlled trials in axSpA. (2) Vignette exercise: 140 scenarios were constructed for a typical patient with axSpA seen at two consecutive visits. Each scenario included a change in one of the following outcomes: pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI plus C-reactive protein (CRP) or Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP. Each Assessment of Spondyloarthritis (ASAS) expert determined if every scenario from a random sample of 46 scenarios was considered a flare (yes/no). Receiver-operating characteristic (ROC) analyses were applied to derive optimal cut-off values. (3) ASAS consensus was reached. Results: (1) The literature review yielded 38 studies using some definition of 'flare', with 27 different definitions indicating important heterogeneity. The most frequent definitions were based on BASDAI changes or pain changes. (2) 121 ASAS experts completed 4999 flare assessments. The areas under the ROC curves were high (range: 0.88-0.89). Preliminary cut-offs for pain (N=3), BASDAI (N=5) and ASDAS-CRP (N=4) were chosen, with a range of sensitivity 0.60-0.99 and range of specificity 0.40-0.94 against the expert's opinions. Conclusions: This data-driven ASAS consensus process has led to 12 preliminary draft definitions of 'flare' in axSpA, based on widely used indices. These preliminary definitions will need validation in real patient data. (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)