SAT0164 Adverse drug reactions due to disease modifying drugs in patients with incident rheumatoid arthritis

Abstract

Background:There is a well-known risk of developing adverse drug reactions (ADR) in rheumatology due, mainly, to the Disease Modifying Antirheumatic Drugs (DMARD) used. There is no doubt about their efficacy in Rheumatoid Arthritis (RA), but it is necessary to increase our knowledge of their ADR, especially those that lead to discontinuationObjectives:To describe the incidence and characteristics of ADR related with DMARD in patients with incident RA as well as the factors involved in their developmentMethods:Observational retrospective longitudinal study between April 15th 2007 and December 31st 2016. Inclusion criteria: patients diagnosed with RA between April 15th 2007 and June 31st 2011 followed until December 31st 2016 whom started any DMARD. Primary endpoint: development of an ADR that required discontinuation of the DMARD (moderate: discontinuation; severe: discontinuation with hospitalization or death). Co-variables: sociodemographic; clinical and therapy. Statistical analysis: incidence rates of discontinuation (IR) per 100 patient-years were estimated using survival techniques with their respective 95% confidence interval [CI]. Comparisons between associated factors were run by Cox bivariate and multivariate regression models. Results were expressed by hazard ratio (HR) and [CI]Results:We included 1054 courses of DMARD treatment in 405 patients (2277.9 patient-years). 78.3% were women with a mean age at diagnosis of 57±15 years. During follow-up, 16.3% of patients were taking biological DMARD, 73.3% were using monotherapy and 89% were taking corticoids. There were 369 ADR in 212 patients, 88.9% moderate. Gastrointestinal was the most frequent cause of ADR (26.3%), followed by infections (12.2%). IR are shown in table 1 and the multivariate analysis in table 2. Regarding type of DMARD, Abatacept had the highest risk of ADR development (HR:4.9[2.1–11.2]) compared to the other drugs followed by Gold (HR:1.6[1–2.6]) and Leflunomide (HR:1.4[1.1–1.9]). Methotrexate was the safest drug compared with the others (0.6[0.5–0.8])Table 1GlobalWomenMen2277.91835.4442.53692967316.216.116.514.6–17.914.4–18.113.1–20.7 By therapy regimenMonotherapyDouble therapyTriple therapy 1609.5568.999.4 20013237 12.423.237.2 10.8–14.319.6–27.526.9–51.4By type of DMARDSyntheticBiological 2048.3229.5 32643 15.918.7 14.3–17.713.9–25.3By drugAbataceptAdalimumabAntimalarialsAzathioprineCertolizumabEtanerceptGolimumabInfliximabLeflunomideMethotrexateGoldRituximabSulfasalazine 8.381.5749.7191665.29.118.4340.41463.583.626.3154 5101573412568520633145 60.612.320.915.724.818.454.932.72514.139.53.829.2 25.2–145.56.6–22.817.9–24.55.1–48.89.3–66.210.5–32.422.9–131.914.7–72.720.2–30.912.3–16.128–55.50.5–2721.8–39.1Table 2MonotherapyDouble therapyTriple therapy12 4.2-1.5–2.52.6–6.8-0 0 Congestive heart failure1.81.2–2.70.002Liver disease21.2–3.30.012Conclusions:The IR of ADRwas 16.2%, being similar in all age categories. Gastrointestinal was the main cause of ADR followed by infections. We have found differences in discontinuation rates among DMARD ...

Poor Translatability of Biomedical Research Using Animals — A Narrative Review

“…The disease most commonly begins in middle age, in the midst of working life, with significant social and economic impact, 92 despite currently available drug treatments. [93][94][95][96] Current treatment options of RA involve non-steroidal anti-inflammatory drugs, glucocorticoids and diseasemodifying anti-rheumatic drugs (DMARDs), such as methotrexate. For patients who fail to respond satisfactorily to these drugs, the additional use of biologic DMARDs, in particular tumour necrosis factor-α (TNF-α) inhibitors, offer greater chances for disease management.…”