Background/Purpose: Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune chronic disease with disability and deforms joints. After the introduction of biological therapies the prognosis of patients has improved. Approximately one-third of patients do not respond to treatment with conventional disease modifying drugs (sDMARDs). There are registers about adverse events (AE) of biological drugs disease modifying (bDMARDs), BIOBADASAR registry in Argentina with a frequency of adverse events with the use of biologicals of 26%, with respiratory tract infections being the most frequent. According to the BIOBADASER record loss of efficacy is the most frequent cause with more than 42% of cases, infections 21%. Since we do not have reports of this type, our objective is to describe the AE in patients with RA treated with bDMARDs anti TNF and non anti TNF. The bDMARDs used were adalimumab (ADA), golimumab (GLM), Etanercept (ETN) as anti TNF, anti IL6 Tocilizumab (TCZ) and anti CD20 Rituximab (RTX).

Methods: A descriptive, ambispective cross-sectional study. Data were collected from the rheumatology service of Hospital Docente Padre Billini, which is a national reference hospital. Statistical analyses were performed using SPSS (V.23). We included all patients diagnosed with RA according to 2010 ACR/EULAR classification criteria treated with bDMARDs during the period January 2013 – April 2017. Patients who did not have continuous follow-up by rheumatology of at least 3 consecutive consultations in one year were excluded.

Results: We have 863 patients diagnosed with RA, 398 patients treated with bDMARDs, 220 patients met inclusion criteria. 93% were women, mean age 57.2 years old, time of disease 9.9 years. The bDMARDs distributions was 51.4% TCZ, 19.9% ADA, 12.3% ETN, 9.1% GLM, 7.7% RTX. 46.8% had AE: 37.2% treated with ADA, 48.1% ETN, 30% GLM, 23.5% RTX, 56.6% TCZ. In the follow-up we found a 5% therapeutic failure of which 45.5% were by ADA, 18.2% ETN, 18.2 TCZ%, 9.1% RTX, 9.1% GLM. 14.1% presented infections of which 16% were serious. 0.9% adverse event were due to pulmonary tuberculosis (TB). 8.6% dyslipidemia of these 73.7% were TCZ, 6.4% hypertransaminemia of these 71.4% TCZ. 6.4% (13) neutropenia. 1.4% was diagnosed with neoplasm.

Conclusion: We found 46.8% of AE of these only 4.8 were serious unlike other records that report a 13.1%. Patients had a good therapeutic response, in spite of the economic limitations of the population and the shortage of drugs occasionally. The majority of patients used in our cohort TCZ. Even though a tropical country with high TB prevalence of we only found two patients.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/adverse-events-in-rheumatoid-arthritis-patients-treated-with-disease-modifying-biological-drugs-at-hospital-docente-padre-billini-in-santo-domingo/