Treatment comparison in rheumatoid arthritis: head-to-head trials and innovative study designs.
Over the last decades, the increasing knowledge in the area of rheumatoid arthritis has progressively expanded the arsenal of available drugs, especially with the introduction of novel targeted therapies such as biological disease modifying antirheumatic drugs (DMARDs). In this situation, rheumatologists are offered a wide range of treatment options, but on the other side the need for comparisons between available drugs becomes more and more crucial in order to better define the strategies for the choice and the optimal sequencing. Indirect comparisons or meta-analyses of data coming from different randomised controlled trials (RCTs) are not immune to conceptual and technical challenges and often provide inconsistent results. In this review we examine some of the possible evolutions of traditional RCTs, such as the inclusion of active comparators, aimed at individualising treatments in real-life conditions. Although head-to-head RCTs may be considered the best tool to directly compare the efficacy and safety of two different DMARDs, surprisingly only 20 studies with such design have been published in the last 25 years. Given the recent advent of the first RCTs truly comparing biological DMARDs, we also review the state of the art of head-to-head trials in RA.
Department of Rheumatology, Gaetano Pini Institute Via Gaetano Pini 9, 20121 Milano, Italy.
Ennio Giulio
EG
Favalli
Division of Rheumatology, University of Pavia, IRCCS Policlinico San Matteo Foundation, Piazzale Golgi 2, 27100 Pavia, Italy.
Serena
S
Bugatti
Department of Rheumatology, Gaetano Pini Institute Via Gaetano Pini 9, 20121 Milano, Italy.
Martina
M
Biggioggero
Division of Rheumatology, University of Pavia, IRCCS Policlinico San Matteo Foundation, Piazzale Golgi 2, 27100 Pavia, Italy.
Roberto
R
Caporali
D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D016896:Treatment Outcome
D018501:Antirheumatic Agents