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The effect of rilonacept versus placebo on health-related quality of life in patients with poorly controlled familial Mediterranean fever.
[familial mediterranean fever]
To
examine
the
effect
of
rilonacept
on
the
health-related
quality
of
life
(
HRQoL
)
in
patients
with
poorly
controlled
familial
Mediterranean
fever
(
FMF
)
.
As
part
of
a
randomized
,
double
-blinded
trial
comparing
rilonacept
and
placebo
for
the
treatment
of
FMF
,
patients
/
parents
completed
the
modified
Child
Health
Questionnaire
(
CHQ
)
at
baseline
,
and
at
the
start
and
end
of
each
of
4
treatment
courses
,
2
each
with
rilonacept
and
placebo
.
Fourteen
subjects
were
randomized
;
mean
age
was
24
.
4
±
11
.
8
years
.
At
baseline
the
physical
HRQoL
score
was
significantly
less
(
24
.
2
±
49
.
5
)
but
the
psychosocial
score
was
similar
to
the
population
norm
(
49
.
5
±
10
.
0
)
.
There
were
significant
improvements
in
most
HRQoL
concepts
after
rilonacept
but
not
placebo
.
Significant
differences
between
rilonacept
and
placebo
were
found
in
the
physical
(
33
.
7
±
16
.
4
versus
23
.
7
±
14
.
5
,
P
=
0
.
021
)
but
not
psychosocial
scores
(
51
.
4
±
10
.
3
versus
49
.
8
±
12
.
4
,
P
=
0
.
42
)
.
The
physical
HRQoL
was
significantly
impacted
by
the
treatment
effect
and
patient
global
assessment
.
Treatment
with
rilonacept
had
a
beneficial
effect
on
the
physical
HRQoL
in
patients
with
poorly
controlled
FMF
and
was
also
significantly
related
to
the
patient
global
assessment
.
This
trial
is
registered
with
ClinicalTrials
.
gov
Identifier
NCT
00582907
.
