Background COMPLETE-AS is an ongoing, multicenter, observational epidemiological study expected to enroll a total of 1,120 patients with ankylosing spondylitis (AS) from approximately 60 sites across Canada. The main objectives of this study is to compare the real – world effectiveness of adalimumab to NSAIDS and traditional non-biologic DMARDs in the management of extra-articular manifestations (EAMs) and to describe the burden of illness of AS and EAMs in terms of quality of life, health care utilization, work productivity, depression and psychological impairment in patients treated for two years.
Objectives To describe demographics and baseline disease parameters of the cohort.
Methods This pre-specified interim analysis includes patients enrolled between July 2011 and August 2013. Eligible participants must be ≥18 years old; have active AS per the judgment of the treating physician; require treatment change due to inadequate response or non-tolerance to current NSAID or DMARD treatment for AS. Patients are followed every 3 to 6 months following treatment change, according to the investigator's practice, for up to two years. Parameters captured include disease activity measures (BASDAI, BASFI), quality of life data (SF-36, BDI-II), and work limitations (WLQ).
Results Of the 288 patients enrolled to date, 56.6% are male and 85.4% Caucasian. At baseline, mean (SD) age was 43.3 (13.6) years, and mean (SD) time from diagnosis was 5.5 (9.5) years; 64.8% were HLA-B27 positive, 22.9% were treated with a previous/concomitant DMARD [mean (SD) number 1.1 (0.3)], and all patients were biologic naïve. Mean (SD) baseline BASDAI and BASFI were 5.97 (2.06) and 5.06 (2.55), respectively. Baseline mean (SD) SF-36 PCS and MCS, and BDI-II were 27.6 (1.1) and 16.4 (1.1), and 13.6 (9.82). With respect to EAMs, history of IBD, uveitis and psoriasis was reported for 14.8%, 22.7% and 15.7% of patients with available data, respectively. Enthesitis at the Achilles tendon or plantar fascia was present in 17.3% of pts. Patients reported a mean loss of 16.9% in health-related work productivity while 9.7% of patients were unemployed due to disability.
Patients enrolled in COMPLETE-AS are comparable to those observed in another Canadian cohort, Toronto AS registry1, with the exception of lower proportion of male and HLA-B27 positive patients, and a higher prevalence of psoriasis.
Conclusions A noteworthy proportion of AS patients enrolled in this real-world observational study has EAM and work limitation. Further analysis will evaluate the impact of disease manifestations on health quality of life and work productivity.
Caplan L et al. Ankylosing Spondylitis Clinical Registries: Principles, Practices and Possibilities. Am J Med Sci 2013;345(6):437–439
Disclosure of Interest : L. Bessette Grant/research support: Abbvie, Consultant for: Abbvie, Speakers bureau: Abbvie, B. Haraoui Grant/research support: Abbvie, Consultant for: Abbvie, M. Khraishi Grant/research support: Abbvie, W. Bensen Grant/research support: Abbvie, Consultant for: Abbvie, Speakers bureau: Abbvie, J. John Sampalis Consultant for: Abbvie, M. Veronneau Shareholder of: abbvie, Employee of: Abbvie