Open AccessMonitorNet: studio italiano osservazionale multicentrico per la valutazione del profilo rischio-beneficio dei farmaci biologici nella pratica clinica reumatologica
Author(s) -
Paolo Sfriso,
Fausto Salaffi,
C. Montecucco,
Stefano Bombardieri,
S Todesco
Publication year - 2011
Publication title -
reumatismo
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.294
H-Index - 25
eISSN - 2240-2683
pISSN - 0048-7449
DOI - 10.4081/reumatismo.2009.132
Subject(s) - medicine , rheumatology , psoriatic arthritis , observational study , ankylosing spondylitis , rheumatoid arthritis , adverse effect , interim analysis , epidemiology , biologic agents , clinical trial
Over the last decade, several new biologic agents have become available for the treatment of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and psoriasis (Ps). In contrast to conventional disease modifying anti-rheumatic drugs (DMARDs), these biological agents have rapid onset of action and pronounced disease reducing activity when administered as monotherapy or in combination with MTX. Pre-registration randomised clinical trials have compared biological agents against placebo over a limited time span (1-3). Wider use of biologics has resulted in reports of a wide range of adverse events (4), including evidence of reactivation of latent tuberculosis, increased incidence..