Background EviraEAST was a prospective, single-arm, multicountry observational study conducted in 6 Eastern European countries and Israel.
Objectives The aim was to evaluate clinical outcomes, safety, and compliance with adalimumab (ADA) therapy in adult patients with active rheumatoid arthritis (RA), psoriatic arthritis, or ankylosing spondylitis in clinical practice. Data of the RA patient subset are presented herein.
Methods Patients were included if they were eligible for ADA therapy according to the local product label and prescription guidelines. 7 patient visits were indicated during the maximum 13-month observational period. RA disease activity was evaluated by DAS28ESR, physical function by HAQ-DI, compliance by reporting missed injections, and safety by adverse event reporting. The primary endpoint was the proportion of patients with a DAS28 decrease of ≥1.2 within the first 3 months of ADA therapy. Descriptive statistics (mean ± SD or frequency tables) were used.
Results 440 RA patients (54% of total study population) were enrolled; 98% of them had sufficient data for statistical analysis (84% female, age 54.0±11.5 years, RA duration 9.4±8.2 years) and were observed for 49.2±16.2 weeks of ADA treatment. 87% of patients had high disease activity at baseline (DAS28>5.1), 76% received ≥2 previous (DMARDs), and 15% were biologic experienced. The primary endpoint was achieved in 65% of patients, whereas DAS28 decrease of ≥1.2 was observed in 84% of patients by study end (last value observed). DAS28 decreased from 6.5±1.0 at baseline to 3.7±1.6 at study end. 27% of patients were in clinical remission (DAS28 <2.6) and 46% had at least low disease activity (LDA; DAS28 <3.2) at study end. Time to first remission/LDA is shown in the Table. HAQ-DI declined from 1.8±0.6 at baseline to 1.1±0.7 at study end. The predominant ADA dosing was 40 mg every other week (98% of patients); 90% of patients received concomitant DMARDs (MTX 62%, LEF 33%) and 44% received corticosteroids. The proportion of patients with no missed ADA injections was >93% throughout the study. 25% of patients discontinued ADA prematurely, most often due to investigator's decision or lack of efficacy. 28 serious adverse events occurred in 18 patients (4.2%). The most common were infections and infestations, followed by cardiac disorders. The sole death was due to sepsis.
Conclusions EviraEAST confirmed the effectiveness and safety of ADA and showed high compliance with ADA therapy in long-standing RA patients treated in clinical practice in Eastern Europe. High percentages of patients achieved remission/LDA at 6–12 months on ADA therapy.
Acknowledgements The design, study conduct, and financial support for the clinical trial were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract.
Disclosure of Interest None declared