Impacto do uso de agentes ANTI-TNF á na funcionalidade de pacientes com Artrite Reumatoide, Espondilite Anquilosante e Artrite Psoriásica

Abstract

Rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) are chronic inflammatory diseases that affect a portion of the worlds population leading to direct physical limitation with impairment in functionality and quality of life. Treatment regarding this conditions involves symptomatic issues (corticosteroids and nonsteroidal anti-inflammatory drugs), direct action in the disease process (synthetic Disease Modifying Anti-Rheumatic Drugs) and reduction in the of proinflammatory cytokines activity (biological agents). With treatment, the carriers of these diseases has demonstrated significant improvement in functionality and quality of life. The aim of this study was to evaluate the impact on the functionality in patients with RA, PsA, and AS receiving the anti-TNF agents adalimumab, etanercept and infliximab, through a prospective cohort study conducted in the Regional Health Administration in Belo Horizonte, Minas Gerais. Data were collected by standardized form prepared by the Research Group of Pharmacoepidemiology (GPFE) to investigate drug utilization and adverse reactions, comorbidities, activity measure of rheumatic diseases and evaluation of the functionality and quality of life. The interviews were conducted in three stages: first interview (first dispensation), second interview (at least six months after completion of the first interview) third interview (at least six months after completion of the second interview). Until March 2013, 334 patients who received first dispensation of anti-TNF agents at the Unified Health System (SUS) and agreed to participate in the interviews were included in the study. The population consisted of 218 (65.3%) rheumatoid arthritis patients, 69 (20.7%) ankylosing spondylitis patients and 47 (14.0%) psoriatic arthritis patients. Most participants used adalimumab (ADA) (73.1%), while 22.8% etanercept (ETA) and 4.2% used infliximab (INF). One hundred and thirty-six (40.7%) participants used concomitantly, Methotrexate, 216 any Disease Modifying Anti-Rheumatic Drugs (DMARDs), 218 (65.3%) corticosteroids and 112 (35.0%) nonsteroidal anti-inflammatory drugs (NSAIDs). The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) presented values > 4 for AS and PsA, indicating high disease activity in patients starting treatment. The Clinical Disease Activity Index (CDAI) presented values > 22 for both RA and PsA, indicating high disease activity, with no statistically significant difference between the diseases (p = 0.120). The functionality measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) had a mean score (SD) of 1.35 (0.68) for all participants at the beginning of treatment. The RA patients had the higher mean HAQ-DI (SD) value 1.45 (0.67), while AS patients had the lowest 1.11 (0.66), with significant difference between the three diseases (p = 0.003). Mean (SD) EuroQol-5 dimensions (EQ-5D) for the entire cohort was 0.60 (0.18) with no statistically significant difference between the three diseases (p = 0.201). Multivariate regression analysis showed that being female, being married, with a value of general health status assessed by the EQ-5D <0.6 and aged over 50 years are factors statistically associated with worse functional response at baseline , according to the HAQ-DI measure. For the three groups of patients evaluated there was statistically significant correlation between the values of HAQ-DI and measures of disease activity and quality of life (p <0.001). The most frequent adverse events were alopecia, asthenia, headache, influenza, hypertension, upper respiratory tract infection, urinary tract infection, nausea, pruritus, rash and reaction at the application site. Functionality compared results were obtained to 138 patients after 12 months of study. In the first six months, the value of HAQ-DI suffered an average reduction of 0.25 ± 0.59, in the next six months fell on average 0.26 ± 0.39. Within a year of monitoring, the value of HAQ-DI decreased on average 0.51 ± 0.55. Patients who have had prior use of biologic medication showed no significant differences in the functional response at baseline and after six and twelve months of study, compared to patients who did not use. Patients older than 50 years showed no significant differences in the values of HAQ-DI compared to patients aged below 50 years in any evaluation period. An analysis of the baseline variables related to the improvement in functional capacity after one year of study showed that baseline EQ-5D and HAQ-DI are related to functional improvement.