OBJECTIVES: The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a new composite clinical tool combining subjective and objective measures. Using data from the randomized double-blind Ankylosing Spondylitis Study Comparing Enbrel with Sulfasalazine Dosed Weekly (ASCEND) trial, we tested ASDAS validity and assessed its capacity to discriminate between treatment effects and change-from-baseline improvements. METHOD: These post hoc analyses were conducted in patients who received etanercept (50 mg/week) or SSZ (≤ 3 g/day) for 16 weeks. The ASDAS was tested for its capacity to discriminate between those who achieved and did not achieve Assessment of Spondyloarthritis International Society (ASAS) partial remission and ASAS20. Week 16 adjusted treatment differences and effect sizes of improvement from baseline of 42 outcomes were calculated. RESULTS: Means for ASDAS were less than half in patients with ASAS partial remission compared with patients without partial remission across the entire study population (1.2 vs 2.6; P<0.0001). Patients who achieved ASAS20 had greater mean changes from baseline in ASDAS than those who did not (-1.8 vs -0.3; P<0.0001). ASDAS was consistently shown to have one of the highest discriminatory capacities compared with other measurements (including subjective measurements) regardless of normal vs high CRP, presence or absence of peripheral arthritis and high vs very high ASDAS at baseline. As a dichotomous variable using different thresholds for improvement and disease severity, ASDAS had slightly better discriminatory capacity than all corresponding ASAS measures. CONCLUSION: ASDAS is a validated and highly discriminatory tool for the detection of significant differences between treatments for AS as well as for detecting a significant improvement from baseline with etanercept and SSZ.
RCT Entities:
OBJECTIVES: The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a new composite clinical tool combining subjective and objective measures. Using data from the randomized double-blind Ankylosing Spondylitis Study Comparing Enbrel with Sulfasalazine Dosed Weekly (ASCEND) trial, we tested ASDAS validity and assessed its capacity to discriminate between treatment effects and change-from-baseline improvements. METHOD: These post hoc analyses were conducted in patients who received etanercept (50 mg/week) or SSZ (≤ 3 g/day) for 16 weeks. The ASDAS was tested for its capacity to discriminate between those who achieved and did not achieve Assessment of Spondyloarthritis International Society (ASAS) partial remission and ASAS20. Week 16 adjusted treatment differences and effect sizes of improvement from baseline of 42 outcomes were calculated. RESULTS: Means for ASDAS were less than half in patients with ASAS partial remission compared with patients without partial remission across the entire study population (1.2 vs 2.6; P<0.0001). Patients who achieved ASAS20 had greater mean changes from baseline in ASDAS than those who did not (-1.8 vs -0.3; P<0.0001). ASDAS was consistently shown to have one of the highest discriminatory capacities compared with other measurements (including subjective measurements) regardless of normal vs high CRP, presence or absence of peripheral arthritis and high vs very high ASDAS at baseline. As a dichotomous variable using different thresholds for improvement and disease severity, ASDAS had slightly better discriminatory capacity than all corresponding ASAS measures. CONCLUSION: ASDAS is a validated and highly discriminatory tool for the detection of significant differences between treatments for AS as well as for detecting a significant improvement from baseline with etanercept and SSZ.
Authors: Josef S Smolen; Monika Schöls; Jürgen Braun; Maxime Dougados; Oliver FitzGerald; Dafna D Gladman; Arthur Kavanaugh; Robert Landewé; Philip Mease; Joachim Sieper; Tanja Stamm; Maarten de Wit; Daniel Aletaha; Xenofon Baraliakos; Neil Betteridge; Filip van den Bosch; Laura C Coates; Paul Emery; Lianne S Gensler; Laure Gossec; Philip Helliwell; Merryn Jongkees; Tore K Kvien; Robert D Inman; Iain B McInnes; Mara Maccarone; Pedro M Machado; Anna Molto; Alexis Ogdie; Denis Poddubnyy; Christopher Ritchlin; Martin Rudwaleit; Adrian Tanew; Bing Thio; Douglas Veale; Kurt de Vlam; Désirée van der Heijde Journal: Ann Rheum Dis Date: 2017-07-06 Impact factor: 19.103
Authors: Maureen C Turina; Sofia Ramiro; Dominique L Baeten; Philip Mease; Jacqueline E Paramarta; In-Ho Song; Aileen L Pangan; Robert Landewé Journal: Ann Rheum Dis Date: 2015-08-05 Impact factor: 19.103
Authors: Jose Marona; Alexandre Sepriano; Santiago Rodrigues-Manica; Fernando Pimentel-Santos; Ana Filipa Mourão; Nélia Gouveia; Jaime Cunha Branco; Helena Santos; Elsa Vieira-Sousa; Filipe Vinagre; João Tavares-Costa; João Rovisco; Miguel Bernardes; Nathalie Madeira; Rita Cruz-Machado; Raquel Roque; Joana Leite Silva; Mary Lucy Marques; Raquel Miriam Ferreira; Sofia Ramiro Journal: RMD Open Date: 2020-01