de-modified Sharp score (0-440). The Health Assessment Questionnaire (HAQ; scale 0-3) was used to measure patients' average change from baseline scores over time, in physical function.
The ATTRACT study eva luated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate. Approximately 50% of patients were in functional Class III. Patients received placebo, 3 mg/kg or 10 mg/kg infliximab at weeks 0, 2 and 6, and then every 4 or 8 weeks thereafter. All patients were on stable methotrexate doses (median 15 mg/wk) for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Results from week 54 (ACR20, total van der Heijde-modified Sharp score and HAQ) are shown in Table 3. Higher degrees of clinical response (ACR50 and ACR70) were observed in all infliximab groups at 30 and 54 weeks compared with methotrexate alone.
A reduction in the rate of the progression of structural joint damage (erosions and joint space narrowing) was observed in all infliximab groups at 54 weeks (Table 3).
The effects observed at 54 weeks were maintained through 102 weeks. Due to a number of treatment withdrawals, the magnitude of the effect difference between infliximab and the methotrexate alone group cannot be defined.
Table 3
Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT
infliximabb
Controla
3 mg/kg
q 8 wks
3 mg/kg
q 4 wks
10 mg/kg
q 8 wks
10 mg/kg
q 4 wks
All infliximabb
Patients with ACR20 response/Patients eva luated (%)c
15/88 (17%)
36/86 (42%)
41/86 (48%)
51/87 (59%)
48/81 (59%)
176/340 (52%)
Total scored (van der Heijde-modified Sharp score)
Change from baseline (Mean ± SDc )
7.0 ± 10.3
1.3 ± 6.0
1.6 ± 8.5
0.2 ± 3.6
-0.7 ± 3.8
0.6 ± 5.9
Medianc
(Interquartile range)
4.0
(0.5,9.7)
0.5
(-1.5,3.0)
0.1
(-2.5,3.0)
0.5
(-1.5,2.0)
-0.5
(-3.0,1.5)
0.0
(-1.8,2.0)
Patients with no deterioration/patients eva luated (%)c
13/64 (20%)
34/71 (48%)
35/71 (49%)
37/77 (48%)
44/66 (67%)
150/285 (53%)
HAQ change from baseline over timee (patients eva luated)
87
86
85
87
81
339
Mean ± SDc
0.2 ± 0.3
0.4 ± 0.3
0.5 ± 0.4
0.5 ± 0.5
0.4 ± 0.4
0.4 ± 0.4
a: control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study. Concurrent use of stable doses of oral corticosteroids ( 10 mg/day) and/or NSAIDs was permitted, and folate supplementation was given.
b: all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs
c: p < 0.001, for each infliximab treatment group vs. control
d: greater values indicate more joint damage.
e: HAQ = Health Assessment Questionnaire; greater values indicate less disability.
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