Background ASAS40 response has been used as a primary endpoint in clinical trials of patients (pts) with axial spondyloarthritis (axSpA), and ASDAS inactive disease is recommended as a treatment target. However, the relationships between these clinical measures and patient-reported outcomes (PROs) are not well understood.
Objectives To assess the impact of achieving ASAS40 response or ASDAS inactive disease state on PROs among pts with non-radiographic axSpA (nr-axSpA).
Methods Data were drawn from ABILITY-1, a Phase 3 trial of adalimumab (ADA) vs. placebo (PBO) in pts with nr-axSpA (meeting ASAS axial SpA criteria but not modified New York criteria for AS)1. Pts (N=185) were randomized to ADA or PBO for 12 weeks of double-blind treatment. Physical function was assessed with the disability index of the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S). HRQOL was assessed with the Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score. Work productivity was assessed with the Work Productivity and Activity Impairment (WPAI) Questionnaire. For this analysis, pts were grouped by clinical responses i.e., ASAS40 response and disease activity state (inactive [ASDAS<1.3], moderate [≥1.3 to <2.1], high [≥2.1 to ≤3.5], and very high [>3.5]) at week 12 and further stratified by treatment arm (ADA vs. PBO). Changes in PROs from baseline to Week 12 were compared between groups using ANCOVA with adjustment for baseline scores.
Results Mean baseline HAQ-S and SF-36 PCS scores were 1.02±0.56 and 33.5±8.0, respectively. Mean baseline WPAI domain scores were 57.1±24.7 (activity impairment), 9.8±20.9 (absenteeism), 43.3±25.7 (presenteeism), and 47.5±27.9 (work impairment). At Week 12, clinical improvement was greater in pts on ADA vs. PBO; 47 of 179 pts with non-missing data (38% of ADA vs. 15% of PBO pts, p<0.001) achieved ASAS40 response; 26 of 176 patients with non-missing data (25% of ADA vs. 5% of PBO pts, p<0.001) achieved the ASDAS inactive disease state. ASAS40 response was associated with statistically significant and clinically meaningful improvements from baseline in mean HAQ-S, SF-36 PCS, presenteeism, work impairment, and activity impairment. ASDAS “inactive” was associated with greater improvements from baseline in each PRO compared to ASDAS “very high” (Table).
Conclusions Among pts in ABILITY-1, both ASAS40 response and ASDAS inactive disease state were associated with meaningful improvements in PROs.
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Acknowledgements Eric Bertelsen, PhD, of Arbor Communications provided medical writing and editing services in the development of this abstract. Financial support for these services was provided by AbbVie.
Disclosure of Interest D. van der Heijde Consultant for: AbbVie, Amgen, Aventis, Bristol-Myers Squibb, Centocor, Pfizer, Roche, Schering-Plough, UCB, Wyeth, A. Joshi Shareholder of: AbbVie, Employee of: AbbVie, M. Mittal Shareholder of: AbbVie, Employee of: AbbVie, A. Pangan Shareholder of: AbbVie, Employee of: AbbVie, N. Chen Shareholder of: AbbVie, Employee of: AbbVie, K. Betts Employee of: Analysis Group, which received payment from AbbVie to assist with the research, C. Qi Employee of: Analysis Group, which received payment from AbbVie to assist with the research, Y. Bao Shareholder of: AbbVie, Employee of: AbbVie