Background There is a dearth of data on effectiveness and patient reported outcomes in patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) treated with adalimumab (ADA) in Central and Eastern Europe
Objectives P12–768 study aimed at establishing the impact of ADA on disease activity, extra-articular manifestations (EAMs), functional capacity, work productivity and collecting ADA's safety data in patients with AS and PsA
Methods A prospective, 12-month follow up, single-arm, multi-country observational study enrolling AS and PsA patients eligible for ADA therapy with 3-monthly follow up visits. Upon the presence of axial (ax) or peripheral (per) symptoms, disease activity was assessed by BASDAI and ASDAS or DAS28, whereas functional capacity was assessed by BASFI or HAQ-DI, respectively. Primary endpoint was the percentage of patients with BASDAI 50% decrease (ax) or DAS28 decrease by at least 1.2 (per). WPAI-questionnaire was used to assess productivity impairment. Frequencies of EAMs and serious adverse events (SAEs) were reported. Descriptive statistics and LOCF-analysis were used
Results 566 subjects were enrolled, 555 had sufficient data for statistical analysis (72.6% AS; 27.2% PsA); 449 completed last visit. 64.9% were male; mean age was 45.6 (range 18–80) years, mean disease duration 12.2 ± 10.0 years. At baseline 76.1% and 26.1% of patients had axial and peripheral symptoms, respectively. 54.8% of patients previously received NSAIDs and 34.6% were biologic experienced. Primary endpoint was achieved in 76.1% with axial symptoms and in 83.5% with peripheral symptoms. BASFI decreased from 6.8±2.0 to 2.8±2.3 and HAQ-DI from 1.3±0.6 to 0.6±0.5. At baseline, enthesitis was the most frequent EAM in patients with AS (23.1%) followed by uveitis (12.7%). Most frequent EAM in patients with PsA were psoriasis (90.1%) and enthesitis (17.2%). Percentage of patients with EAMs decreased from 40.4% to 9.7% (AS) and from 90.1% to 46.4% (PsA), whereas proportion of patients free of EAMs increased from 46.1% to 79.5% by study end. Total activity impairment decreased from 64.3% to 28.0%. Among all employed patients (n=255; 45.9% at baseline) presenteeism decreased from 56.7% to 20.1%, absenteeism from 15.6% to 6.4% and total work productivity impairment from 59.9% to 22.1%. 52 episodes of SAEs occurred in 26 patients (4.7%)
Conclusions Adalimumab was effective in improving clinical, functional and working status and reduced frequency of EAMs in patients with AS and PsA in routine clinical use. No new safety signals were observed.
Disclosure of Interest P. Géher Grant/research support from: Abbott, MSD, UCB, Wyeth, Consultant for: Abbott, AbbVie, EGIS, MSD, Roche, UCB, Wyeth, Speakers bureau: Abbott, AbbVie, Berlin Ch, EGIS, MSD, Roche, UCB, Wyeth, S. Szántό Grant/research support from: AbbVie, Pfizer, MSD, UCB, Consultant for: AbbVie, EGIS, MSD, Roche, UCB, Pfizer, Speakers bureau: Abbott, AbbVie, Berlin Ch, EGIS, MSD, Pfizer, Roche, UCB, Valeant, D. Opriş Consultant for: AbbVie, UCB, MSD, Teva, Speakers bureau: UCB, MSD, Eli Lilly, Pfizer, Roche, Sanofi, Teva, BMS, O. Iaremenko Consultant for: AbbVie, MSD, Roche, DILEO, Pfizer, Speakers bureau: AbbVie, MSD, Roche, DILEO, O. Nagy Employee of: AbbVie, V. Chernyshov Employee of: AbbVie