st 26 weeks) through week 102 for Study RA
I and week 54 for Study RA II.
a
P ≤ 0.001
b P < 0.01 c P < 0.05
Table 8 Components of ACR 20 at baseline and 54 weeks (Study RA I)
Placebo + MTX Infliximab + MTXa
(n = 88) (n = 340)
Parameter (medians) Baseline Week54 Baseline Week54
No. of Tender Joints 24 16 32 8
No. of Swollen Joints 19 13 20 7
Painb 6.7 6.1 6.8 3.3
Physician’s Global Assessmentb 6.5 5.2 6.2 2.1
Patient’s Global Assessmentb 6.2 6.2 6.3 3.2
Disability Index (HAQ-DI)c 1.8 1.5 1.8 1.3
CRP (mg/dL) 3.0 2.3 2.4 0.6
a All doses/schedules of infliximab + MTX
b Visual Analog Scale (0=best, 10=worst)
c Health Assessment Questionnaire, measurement of 8 categories: dressing and grooming, arising, eating,walking, hygiene, reach, grip, and activities (0=best, 3=worst)
Radiographic responseStructural damage in both hands and feet was assessed radiographically at Week 54 by thechange from baseline in the van der Heijde-modified Sharp (vdH-S) score, a composite scoreof structural damage that measures the number and size of joint erosions and the degree ofjoint space narrowing in hands/wrists and feet.3In Study RA I, approximately 80% of patients had paired X-ray data at 54 weeks andapproximately 70% at 102 weeks. The inhibition of progression of structural damage wasobserved at 54 weeks (Table 9) and maintained through 102 weeks.
In Study RA II, >90% of patients had at least 2 eva luable X-rays. Inhibition of progression ofstructural damage was observed at Weeks 30 and 54 (Table 9) in the infliximab + MTXgroups compared to MTX alone. Patients treated with infliximab + MTX demonstrated lessprogression of structural damage compared to MTX alone, whether baseline acute-phasereactants (ESR and CRP) were normal or elevated: patients with elevated baseline acutephasereactants treated with MTX alone demonstrated a mean progression in vdH-S score of4.2 units compared to patients treated with infliximab + MTX who demonstrated 0.5 units ofprogression; patients with normal baseline acute phase reactants treated with MTX alonedemonstrated a mean progression in vdH-S score of 1.8 units compared to infliximab + MTXwho demonstrated 0.2 units of progression. Of patients receiving infliximab + MTX, 59%had no progression (vdH-S score ≤ 0 unit) of structural damage compared to 45% of patientsreceiving MTX alone. In a subset of patients who began the study without erosions,infliximab + MTX maintained an erosion-free state at 1 year in a greater proportion of
patients than MTX alone, 79% (77/98) vs. 58% (23/40), respectively (P<0.01). Fewerpatients in the infliximab + MTX groups (47%) developed erosions in uninvolved jointscompared to MTX alone (59%).
Table 9 Radiographic change from baseline to Week 54
Study RA I Study RA II
Infliximab + MTX Infliximab + MTX
3 mg/kg 10 mg/kg 3 mg/kg 6 mg/kg
Placebo
+ MTX
q8
wks
q8
wks
Placebo
+ MTX
q8
wks
q8
wks
(n = 64) (n = 71) (n = 77) (n = 282) (n = 359) (n = 363)
Total score
Baseline
Mean 79 78 65 11.3 11.6 11.2
Median 55 57 56 5.1 5.2 5.3
Change from baseline
Mean 6.9 1.3a 0.2a 3.7 0.4a 0.5a
Median 4.0 0.5 0.5 0.4 0.0 0.0
Erosion Score
Baseline
Mean 44 44 33 8.3 8.8 8.3
Median 25 29 22 3.0 3.8 3.8
Change from baseline
Mean 4.1 0.2a 0.2a 3.0 0.3a 0.1a
Median 2.0 0.0 0.5 0.3 0.0 0.0
JSN Score
Baseline
Mean 36 34 31 3.0 2.9 2.9
Median 26 29 24 1.0 1.0 1.0
Change from baseline
Mean 2.9 1.1a 0.0a 0.6 0.1a 0.2
Median 1.5 0.0 0.0 0.0 0.0 0.0 a P < 0.001 for each outcome agains |
