title: Clinical trials in systemic lupus erythematosus (SLE): lessons from the past as we proceed to the future--the EULAR recommendations for the management of SLE and the use of end-points in clinical trials.
abstract: Among rheumatic diseases, lupus, especially nephritis, has been more extensively studied with several controlled clinical trials as reported in the literature. The large number of studies on the diagnosis and management of the disease have created a plethora of data that need to be systemically reviewed and formulated in recommendations to be used in daily practice. Moreover, the increasing number of new agents holding the promise of improved efficacy and safety profiles over traditional treatments in systemic lupus erythematosus (SLE) has provided the impetus for optimal design of clinical trials. To this end, and under the auspices of European League Against Rheumatism (EULAR), we developed recommendations for the management of SLE and for points to consider in the design of SLE trials. These recommendations were developed using a combination of research-based evidence following a systematic literature search of trials and cohort studies, and expert consensus. Twelve statements concerning the management of SLE and points regarding the eligibility criteria and outcome measures to be included in trials were developed and are briefly reviewed here. The literature search showed that there have been few high quality Randomized controlled trails (RCTs) in SLE, particularly for manifestations other than nephritis and thus, several important issues have not been adequately addressed. Importantly, end-points currently used in SLE trials have not actually been validated in clinical trials. These findings underscore the need to establish international networks to facilitate clinical trials addressing these issues and testing new therapies.
authors.affiliation: Internal Medicine and Rheumatology, Clinical Immunology and Allergy, University of Crete School of Medicine, Heraklion, Greece.
authors.forename: G
authors.initials: G
authors.lastname: Bertsias
authors.forename: C
authors.initials: C
authors.lastname: Gordon
authors.forename: D T
authors.initials: DT
authors.lastname: Boumpas
mesh_terms: D001172:Arthritis, Rheumatoid / Q000276:immunology / Q000628:therapy; D002986:Clinical Trials as Topic; D005060:Europe; D006287:Health Planning Guidelines; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000235:genetics / Q000276:immunology* / Q000378:metabolism / Q000628:therapy*; D011788:Quality of Life; D012955:Societies, Medical