EMA guidelines
March 13, 2013
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 and systemic lupus
erythematosus.
“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,” the EMA
said in a statement.
“Therefore, there is a need for
the development of effective
medicines to treat this condition,”
the EMA added.
According to the Guideline,
patients with a diagnosis of SLE,
according to the American College
of Rheumatology revised
classification criteria or SLICC SLE
criteria should be enrolled in the
trials.
Acceptable endpoints for trials
include reduction of disease
activity/induction of remission
parameters; decrease of the
cumulative steroid dose,
prevention of flares/increased time
intervals between flares
(maintenance of remission) and
prevention of long term damage.
For more details on the Guideline
visit the EMA’s website at
www.ema.europa.eu.
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