AbstractsBiology & Animal Science

Efficacy, Safety and Clinical Outcomes of Biologic Drugs in the Treatment of Rheumatoid Arthritis

by Kalle Aaltonen

Institution: University of Helsinki
Department: Division of Pharmacology and Pharmacotherapy
Year: 2015
Keywords: farmasia
Record ID: 1144390
Full text PDF: http://hdl.handle.net/10138/154182


Rheumatoid Arthritis (RA) is an autoimmune disease, which is treated with anti-inflammatory and immunosuppressive medication comprising synthetic disease-modifying anti-rheumatic (sDMARDs) and biologic drugs. In this thesis all published randomized controlled trials studying the efficacy and safety of biologic drugs based on the inhibition of tumor necrosis factor (TNF) were identified, evaluated and pooled in using a systematic review including a meta-analysis. Then we pursued a cross-sectional overview on disease activity and medical treatment of patients with RA treated wthin the Finnish specialized healthcare. Finally, we executed two cohort studies in which we combined longitudinal patient data with information on the incidence of serious infections, malignancies and joint replacement operations retrieved from national registers. Forty-one articles reporting on 26 RCTs of TNF-inhibitors were included in the systematic review and meta-analysis. TNF-inhibitors as a monotherapy were more efficacious than placebo but comparable to methotrexate (MTX). TNF-inhibitor and MTX combination was superior to either MTX or TNF-inhibitor alone. TNF-inhibitors were relatively safe as compared to either MTX or placebo. The cross-sectional study revealed 91%, 58% and 21% of patients as concurrent users of (sDMARDs), glucocorticoids and biologics, respectively. The cohort studies showed that the adjusted incidence rate ratios (aIRRs) of infections compared to sDMARD users were 0.9 (95% CI 0.6-1.4) and 1.1 (95% CI 0.59-1.9) for the users of TNF-inhibitors and rituximab, respectively. The aIRRs of malignancies were similar between the sDMARD and biologics users. There were more primary joint replacement operations per 100 patient years among the users of biologic drugs (3.89, 95% CI 3.41 4.41) vs. DMARD (2.63, 2.35 2.94) users but slightly fewer revisions (0.65, 0.46 0.88 vs. 0.83, 0.68 1.01). Efficacy and safety of TNF-inhibitors are comparable to MTX and only few differences were observed between individual agents. Currently, more than 20% of Finnish RA patients are using biologic drugs, with a majority of them in combination therapy with sDMARDs. The incidence of serious infections and malignancies is comparable between the users of sDMARDs, TNF-inhibitors and rituximab. Compared to sDMARD users, biologic drugs users had a higher incidence of joint replacement operations while the durability of the prostheses were similar. Nivelreuma on autoimmuunisairaus, jonka oireisiin kuuluu reumatulehduksesta johtuvaa nivelarkuutta- ja turvotusta erityisesti käsissä ja jaloissa. Nivelreuman diagnoosi perustuu lääkärin tekemään arvioon potilaan voinnista, potilaan omaan arvioon oireistaan sekä laboratorio- ja kuvantamistutkimuksiin. Nivelreuman hoito perustuu tulehdusreaktion hillintään ja sen tavoitteena on oireeton tauti. Suomalaisten hoitosuositusten mukaisesti lääkehoito aloitetaan metotreksaatilla tai tarvittaessa metotreksaatin, sulfasalatsiinin ja hydroksiklorokiinin sekä pieniannoksisen prednisolonin yhdistelmähoidolla. Mikäli…