Background there is a highrisk of adverse effects (AEs) in rheumatology clinical practice, mainly due to immunosuppressive drugs used in patients with autoimmune diseases. The high burden of care and the difficulty of recording adverse events in clinical practice with traditionalinformation systems should also be kept in mind.
Objectives to describe adverse effects in patients with rheumatoid arthritis (RA) treated with non-biological DMARDs, included in a routinely clinical practice in the department of Rheumatology, by implementing an Information and Analysis software for recording incidents and adverse effects (SNAIEA).
Methods Design: Prospective observational study from October 1, 2010 until October 1, 2011. Subjects: All patients seen during this period (since the introduction of SNAIEA) in the Department of Rheumatology, in Hospital Cíinico San Carlos of Madrid with clinical diagnosis of RA, treated with DMARDs. Outcomes and data collection: Primary outcome: Adverse effects associated with treatment with different non-biological DMARDs (Methotrexate, Leflunomide, Sulfasalazine or Antimalarials) recorded by SNAIEA. Also recorded a) adverse effect severity (mild, moderate, severe, mortal), b) drug association (unlikely, possible, probable, sure) c) age, sex and disease duration. Analysis: description of the sociodemographic and clinical characteristics of the patients, as well as DMARDs adverse effects using frequency distribution rates, and the mean and standard deviation or median and percentiles. Survival techniques have been used to estimate the incidence of adverse effects, expressing the incidence per 1,000 patient years (95% CI).
Results 1168 patients with RA (78% female, mean age 62±5 years, mean duration of disease 9.9±8 years) took at least one non-biologic DMARDs, generating 138 adverse events secondary to any of these (120 patients) with a rate of 136.2 per 1,000 AE patient years (95% CI 115.2 -160.9). The association with drugs was: Methotrexate (39%), Antimalarials (30%) Leflunomide (26%) and Sulfasalazine (5%). The most frequent causes of AE were: digestive symptoms (34.8%), ophtalmological disease (16%) (97% with Antimalarials), infections (13%) (94% with Methotrexate or Leflunomide), and hematologic disease(12%) (91% with Methotrexate or Leflunomide and the remaining 9% with Sulfasalazine). In 74% of the cases, the association of the AE with the drug was described as probable, 6% as sure, 15% and 5% may improbable. 16.6% of AEs were mild, 72.4% moderate, and 11% severe. There was no AE with deadly results. The incidence of moderate EA was 98.7 per 1,000 inhabitants per year (95% CI: 81.2-120.6).
Conclusions Thenon-biological DMARDs generate a high incidence of AE. The use of SNAIEA has been a transition from the traditional model for electronic manual analysis of adverse effects, identifying them and their severity, and drug association, thus contributing to improving the quality of patient’s care.
Disclosure of Interest None Declared