Christodoulopoulou, A

Gaga, M

Georgatou, N

Loukides, S

Papageorgiou, M

Zervas, L

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A30 Abstracts
received: adalimumab 40mg every other week (eow) + MTX;
adalimumab 40mg eow; or MTX monotherapy. The Short Form
36 (SF-36) was used to assess 8 domains of HRQOL at baseline,
and after 12, 26, 42, 52, 76, and 104 weeks of therapy (higher
scores indicate improvement). Scores for 4 physical and 4 mental
health concepts were aggregated into Physical Component
Summary (PCS) and Mental Component Summary (MCS)
scores. A minimum clinically important difference (MCID) is
2.5–5.0 for PCS and MCS. Criteria-based interpretation of the
PCS evaluated relationships between clinically and socially
meaningful variables. RESULTS: Baseline scores for the 799
patients were comparable between all 3 groups, and post-base-
line results were comparable for the 2 monotherapy groups.
Mean baseline PCS for the adalimumab + MTX (n = 256) and
MTX monotherapy (n = 247) groups were 31.7 and 32.2. Mean
PCS for the combination therapy group at Week 12 had
improved to 42.2 vs. 38.2 for the MTX group. The 4.5 differ-
ence in mean change from baseline was clinically meaningful and
sustained through 2 years (5.1) (p < 0.0001). Based on criteria-
based interpretation of the SF-36, differences in PCS scores
between the 2 groups indicate patients on MTX alone had an
increased likelihood of using more health resources and not
being able to work. CONCLUSIONS: Adalimumab + MTX
were superior to MTX alone in providing signiﬁcant and clini-
cally meaningful improvements in HRQOL in early RA. Signif-
icantly lower PCS at 2 years in the MTX group may mean
patients on MTX alone have greater health care utilization and
substantially greater job loss than patients on combination
therapy.
PAR20
EFFECTS OF LONG-TERM ADALIMUMAB THERAPY ON
HEALTH UTILITY AND FATIGUE IN PATIENTS WITH LONG-
STANDING, SEVERE RHEUMATOID ARTHRITIS (RA)—RESULTS
FROM A 3-YEAR FOLLOW-UP STUDY
Mittendorf T1, Sterz R2,Von der Schulenburg J1, Kupper H2,
Cifaldi M3, Dietz B2
1University of Hannover, Hannover, Germany; 2Abbott GmbH and Co
KG, Ludwigshafen, Germany; 3Abbott Laboratories, Abbott Park, IL,
USA
OBJECTIVES: To investigate the ability of adalimumab therapy
to provide simultaneous, sustained long-term improvement in
two important patient-reported outcomes (health utility and
fatigue) in patients with severe RA who had failed at least one
DMARD. METHODS: The Health Utilities Index Mark 3
(HUI3) and Fatigue (FACIT-F, validated in RA) were simultane-
ously measured in a health economics companion trial to an
adalimumab pivotal study (DE011). For the ﬁrst 26 weeks
patients were followed under double-blind, randomized condi-
tions before rolling over into a long-term, open-label extension
(OLE) (n = 99). A subset of patients receiving adalimumab 40
mg every other week was evaluated for up to 170 weeks. The
HUI3 scale is 0–1, with “1” denoting perfect health and “0”
denoting death. FACIT-F scores range from 0–52, with higher
scores representing less fatigue. Changes in HUI3 of ≥0.03 and
FACIT-F of ≥4 are considered clinically meaningful. RESULTS:
Baseline patient characteristics were: female, 80%; age, 53 years;
duration of disease, 10 years; TJC (0–68), 34; SJC (0–66), 21;
HAQ score, 1.9; C-reactive protein (mg/L), 54; number of pre-
vious DMARDs: 4 (all mean values except % female). RA
patients’ baseline utility and fatigue scores were comparable (vs.
placebo) and approximately one-third of the population norm.
At week 26, mean changes from baseline in adalimumab-treated
patients were 0.18 for HUI3, and 8.54 for FACIT-F (both p <
0.001 vs. baseline). These improvements were sustained through-
out week 170. CONCLUSIONS: Adalimumab provided clini-
cally important, simultaneous improvements in health utility and
fatigue in patients with severe, active RA who had failed at least
one DMARD. These improvements were sustained over the 3-
year observation period.
ASTHMA
PAS1
COMPARISON OF TREATMENT WITH
BUDESONIDE/FORMOTEROL (BUD/FM) PLUS BUD/FM PRN AS
SINGLE INHALER TREATMENT VERSUS REGULAR BUD AND
FM PLUS FM PRN AS MONOPRODUCTS IN PATIENTS WITH
ASTHMA IN GREECE
Papageorgiou M1, Loukides S2, Gaga M3, Zervas L3,
Christodoulopoulou A1, Georgatou N3
1AstraZeneca SA, Athens, Athens, Greece; 2401 Military Hospital,
Athens, Athens, Greece; 3Sotiria Hospital, Athens, Athens, Greece
OBJECTIVE: To compare the efﬁcacy of regular treatment with
BUD/FM plus BUD/FM prn versus regular treatment with budes-
onide (BUD) and formoterol (FM) plus FM prn in the treatment
of asthmatic patients in Greece. METHODS: Moderate asth-
matic (mean FEV1 76% pred.) patients were recruited from 14
centers in Greece to participate in an open-label, randomized
prospective clinical trial. The duration of the study was seven
months with four scheduled visits: baseline, ﬁrst month, third
month and seventh month. Patients were randomized in 2
groups: Group A: BUD/FM 160/4.5 ìg bid plus BUD/FM prn and
Group B: BUD 200 ìg and FM 9 ìg bid plus FM prn. Outcome
measures included lung function, number of exacerbations and
relief inhalations, symptom control using the Asthma Control
Questionnaire (ACQ) and quality of life using the Asthma
Quality of Life Questionnaire (AQLQ). In addition, the use of
health services and side effects were recorded. RESULTS: A total
of 133 patients were recruited, 68 in Group A, and 65 in Group
B. Both groups showed a signiﬁcant improvement in ACQ at the
end of the study (p < 0.0001). Relief inhalations were signiﬁ-
cantly less in Group A (p < 0.0001) during the last study period,
between 3rd and 7th month. No statistically signiﬁcant differ-
ences were found in the other outcome measures. CONCLU-
SIONS: BUD/FM therapy plus BUD/FM as needed demonstrated
similar effectiveness in asthma control and quality of life com-
pared to treatment with BUD and FM plus FM as needed. Since
fewer relief inhalations were recorded in Group A, BUD/FM plus
BUD/FM prn treatment seems preferable for patients with
asthma.
PAS2
FLUTICASONE PROPIONATE/SALMETEROL COMBINATION
IMPROVES HEALTH OUTCOMES AND QUALITY OF LIFE IN
CHILDREN WITH POORLY CONTROLLED ASTHMA IN
IRELAND
Hill P1, Hughes J2, Grant D3, Sawyer W3, Reeves P3
1Blackpool Health Centre, Cork City, Cork, Ireland; 2GlaxoSmithKline
Ireland, Dublin, Ireland; 3Fourth Hurdle Consulting Ltd, London, UK
OBJECTIVE: To investigate whether salmeterol/ﬂuticasone pro-
pionate 50/100mcg (SFC) improves quality of life, physical func-
tioning and asthma symptoms in children with uncontrolled
asthma in primary care. METHODS: A prospective open label
study of children seven to twelve years old attending their GP
with uncontrolled asthma. SFC bd was taken for 16 weeks (w)
from enrolment. Peak expiratory ﬂow rate (PEFR) was measured
at baseline, w4 and w16, when the Paediatric Asthma Quality
of Life Questionnaire (PAQLQ) was completed. Patient diaries


PAS1 COMPARISON OF TREATMENT WITH BUDESONIDE/FORMOTEROL (BUD/FM) PLUS BUD/FM PRN AS SINGLE INHALERTREATMENT VERSUS REGULAR BUD AND FM PLUS FM PRN AS MONOPRODUCTS IN PATIENTS WITH ASTHMA IN GREECE 

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PAS1 COMPARISON OF TREATMENT WITH BUDESONIDE/FORMOTEROL (BUD/FM) PLUS BUD/FM PRN AS SINGLE INHALERTREATMENT VERSUS REGULAR BUD AND FM PLUS FM PRN AS MONOPRODUCTS IN PATIENTS WITH ASTHMA IN GREECE

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