The European Medicines Agency has released the first guideline in the European Union on clinical investigation of medicines for the treatment of lupus erythematosus for public consultation.

Lupus erythematosus is a complex chronic auto-immune inflammatory disease that can affect almost any organ and organ system of the human body. It is divided into two main types: cutaneous (CLE) and systemic lupus erythematosus (SLE). Although recent improvements in treatment regimens and medical care have dramatically reduced mortality and morbidity, many patients still have incompletely controlled disease and progress to end-stage organ failure. Therefore, there is a need for the development of effective medicines to treat this condition.

The Agency issues scientific guidelines to guide and support the preclinical and clinical development of new medicines and increase the chance of having better treatments approved. This guideline describes patient characteristics, inclusion and exclusion criteria and concomitant use of other medicines that should be considered in the recruitment phase. Acceptable endpoints to assess both the disease severity at baseline and the clinical improvement for early and late signs of the disease are necessary. These endpoints include reduction of disease-activity or induction-of-remission parameters, decrease of the cumulative steroid dose, prevention of flares or increased time intervals between flares (maintenance of remission), and prevention of long-term damage. Points that should be considered for inclusion and exclusion criteria and the required efficacy readouts for cutaneous lupus, lupus nephritis and juvenile lupus are also discussed separately within this guideline.

Comments should be submitted by 4 September 2013.


Posted on the EMA website on 5 March 2013