Date: Monday, November 9, 2015
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: Adverse events (AEs) and serious adverse events (SAEs) from disease modifying drugs (DMARDs) for Rheumatoid Arthritis (RA) can result in significant morbidity and even fatality. The American College of Rheumatology (ACR) has published drug safety disease modifying drug (DMARD) guidelines for doctors to follow so that they can monitor side effects. The aim of our study was to audit our practice to see if the ACR guidelines were followed and what impact that had on RA patients with AEs and SAEs.
Methods: We collected data on DMARD and biologic usage of 250 RA patients in a Musculoskeletal clinic in the United Arab Emirates (UAE) and audited the practice to see how many of the ACR drug safety guidelines were being followed. Subsequently we analyzed how many patients suffered from AEs and SAEs (death, initial or prolonged hospitalization, persistent or significant disability, cardiac failure, or myocardial infarction). Outcomes of the AEs and SAEs were recorded.
Results: 518 DMARDs were prescribed to 250 patients (Methotrexate, Arava, Sulfazalazine, Imuran, Plaquenil, Enbrel, Humira, Xeljanz, Simponi, Acterma, and Mabthera). The average duration of DMARD use was 52.4 months. The average age was 47 years, 51 males (20.4%), 199 females (79.6%) and the ethnicities represented were 131 Asian (52.4%), 53 Arab (21.2%), 53 Caucasian (21.2%), 12 African (4.8%), and 1 other (0.4%). All six guidelines; informing patients about risk, prophylaxis for patients at risk for gastrointestinal bleeding, hemoglobin tests, serum creatinine tests, baseline studies, and drug toxicity monitoring were applied to 100% of the patients. 15.6% of all the patients experienced some sort of AE and 0.4% experienced a SAE. Of these patients 74.4% of them discontinued the medication that caused them to have an AE and changed to another DMARD. The reported AEs consisted of increased LFT (27.2%), intolerance (9.1%), infection (9.1%), allergy (9.1%), hair loss (7.3%), skin pigmentation (7.3%), chronic cough (5.5%), chronic low WBC (5.5%), severe injection site reaction (3.6%), discomfort in chest (1.8%), menorrhagia (1.8%), dizziness (1.8%), neoplastic lesion in thyroid (1.8%), psoriasis (1.8%), upper GI bleed (1.8%), asthma (1.8%), eye toxicity (1.8%) and pulmonary hemorrhage (1.8%). Of these AEs only pulmonary hemorrhage (1.8%) was deemed a SAE. All AEs were resolved due to early detection and careful monitoring.
Conclusion: Of the 250 patients administered with 518 drugs, 39 (15.6%) reported AEs of which 1.8% of them were deemed SAEs and 29 patients (74.4%) discontinued the DMARD. All adverse events were resolved with drug discontinuation and no patients had irreversible side effects. We believe that adherence to the ACR DMARD safety guidelines for RA treatment can limit the impact of AEs and SAEs and enhance the safety of patients.
Key Point: Strict adherence to the ACR drug safety guidelines results in patient safety and effective RA treatment.
To cite this abstract in AMA style:Bur D, Badsha HM. Following the American College of Rheumatology Quality Guidelines Can Enhance the Safety of Rheumatoid Arthritis Patients Treated with Disease Modifying Drugs [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/following-the-american-college-of-rheumatology-quality-guidelines-can-enhance-the-safety-of-rheumatoid-arthritis-patients-treated-with-disease-modifying-drugs/. Accessed October 27, 2021.
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