title: ASAS40 and ASDAS clinical responses in the ABILITY-1 clinical trial translate to meaningful improvements in physical function, health-related quality of life and work productivity in patients with non-radiographic axial spondyloarthritis.
abstract: OBJECTIVE
  To assess the impact of achieving Assessment in SpondyloArthritis international Society 40% (ASAS40) response or an Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS-ID) state on patient-reported outcomes (PROs) among patients with non-radiographic axial SpA (nr-axSpA).
  
  
  METHODS
  Data are from ABILITY-1, a phase 3 trial of adalimumab vs placebo in nr-axSpA patients. PROs included the HAQ for Spondyloarthropathies (HAQ-S), 36-item Short Form Health Survey (SF-36) physical component summary (PCS) score and Work Productivity and Activity Impairment Questionnaire. Patients were grouped by clinical response using ASAS40 response and ASDAS disease states at week 12. Changes in PROs from baseline to week 12 were compared between groups using analysis of covariance with adjustment for baseline scores.
  
  
  RESULTS
  At week 12, 47 of 179 patients were ASAS40 responders and 26 of 176 patients achieved ASDAS-ID (ASDAS <1.3). Compared with non-responders (n = 132), ASAS40 responders (n = 47) had a significantly greater improvement in mean HAQ-S (-0.65 vs -0.05, P < 0.0001), SF-36 PCS (12.4 vs 0.7, P < 0.0001), presenteeism (-24.7 vs -2.2, P < 0.0001), overall work impairment (-23.9 vs -2.5, P < 0.0001) and activity impairment (-33.5 vs -0.9, P < 0.0001) at week 12. Similarly, ASDAS-ID, ASDAS clinically important improvement (ASDAS-CII; improvement >1.1) and major improvement (ASDAS-MI; improvement >2.0) were associated with significantly greater improvements from baseline in the majority of the PROs.
  
  
  CONCLUSIONS
  Among nr-axSpA patients, ASAS40, ASDAS-CII and ASDAS-MI response and achievement of ASDAS-ID were associated with statistically significant and clinically meaningful improvements in physical function, health-related quality of life and work productivity in a higher percentage of patients.
authors: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, mail@dvanderheijde.nl.
authors: Désirée
authors: D
authors: van der Heijde
authors: Health Economics & Outcomes Research.
authors: Avani
authors: A
authors: Joshi
authors: Immunology Clinical Development, AbbVie Inc., North Chicago, IL and.
authors: Aileen L
authors: AL
authors: Pangan
authors: Health Economics & Outcomes Research.
authors: Naijun
authors: N
authors: Chen
authors: Analysis Group, Boston, MA, USA.
authors: Keith
authors: K
authors: Betts
authors: Health Economics & Outcomes Research.
authors: Manish
authors: M
authors: Mittal
authors: Health Economics & Outcomes Research.
authors: Yanjun
authors: Y
authors: Bao
mesh_terms: D000203:Activities of Daily Living; D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D009043:Motor Activity / Q000502:physiology*; D011379:Prognosis; D011788:Quality of Life; D012720:Severity of Illness Index; D012955:Societies, Medical; D025241:Spondylarthritis / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000068879:Adalimumab
keywords: activities of daily living; adalimumab; ankylosis; axial spondyloarthritis; health-related quality of life; magnetic resonance imaging; sacroiliitis; work productivity