tage of patients with 1 or more joints
with dactylitis and percentage of patients with enthesopathy at baseline and
Week 24
Placebo Infliximab 5 mg/kga
Patient randomized (n = 100) (n = 100)
Baseline Week 24 Baseline Week 24
Parameter (medians)
No. of Tender Jointsb 24 20 20 6
No. of Swollen Jointsc 12 9 12 3
Paind 6.4 5.6 5.9 2.6
Physician’s Global Assessmentd 6.0 4.5 5.6 1.5
Patient’s Global Assessmentd 6.1 5.0 5.9 2.5
Disability Index (HAQ-DI)e 1.1 1.1 1.1 0.5
CRP (mg/dL)f 1.2 0.9 1.0 0.4
% Patients with 1 or more digits
with dactylitis 41 33 40 15
% Patients with enthesopathy 35 36 42 22
a P<0.001 for percent change from baseline in all components of ACR 20 at Week 24, P<0.05 for % of patientswith dactylitis, and P=0.004 for % of patients with enthesopathy at Week 24
b Scale 0-68 c Scale 0-66
d Visual Analog Scale (0=best, 10=worst)
e Health Assessment Questionnaire, measurement of 8 categories: dressing and grooming, arising, eating,
walking, hygiene, reach, grip, and activities (0=best, 3=worst)
fNormal range 0-0.6 mg/dL
Improvement in Psoriasis Area and Severity Index (PASI) in psoriatic arthritis patients withbaseline body surface area (BSA) ≥ 3% (n = 87 placebo, n = 83 infliximab) was achieved at Week 14, regardless of concomitant methotrexate use, with 64% of infliximab-treatedpatients achieving at least 75% improvement from baseline vs. 2% of placebo-treated patients;improvement was observed in some patients as early as Week 2. At 6 months, the PASI 75and PASI 90 responses were achieved by 60% and 39%, respectively, of patients receivinginfliximab compared to 1% and 0%, respectively, of patients receiving placebo. The PASIresponse was generally maintained through Week 54. [See also Clinical Studies (14.8)].
Radiographic response
Structural damage in both hands and feet was assessed radiographically by the change frombaseline in the van der Heijde-Sharp (vdH-S) score, modified by the addition of hand DIPjoints. The total modified vdH-S score is a composite score of structural damage thatmeasures the number and size of joint erosions and the degree of joint space narrowing (JSN)in the hands and feet. At Week 24, infliximab-treated patients had less radiographicprogression than placebo-treated patients (mean change of -0.70 vs. 0.82, P < 0.001).
infliximab-treated patients also had less progression in their erosion scores (-0.56 vs 0.51)and JSN scores (-0.14 vs 0.31).
The patients in the infliximab group demonstrated continued inhibition of structural damageat Week 54. Most patients showed little or no change in the vdH-S score during this 12-monthstudy (median change of 0 in both patients who initially received infliximab or placebo).
More patients in the placebo group (12%) had readily apparent radiographic progressioncompared with the infliximab group (3%).
Physical function
Physical function status was assessed using the HAQ Disability Index (HAQ-DI) and the SF-36 Health Survey. infliximab-treated patients demonstrated significant improvement inphysical function as assessed by HAQ-DI (median percent improvement in HAQ-DI scorefrom baseline to Week 14 and 24 of 43% for infliximab-treated patients vs 0% for placebotreatedpatients).
During the placebo-controlled portion of the trial (24 weeks), 54% of infliximab-treatedpatients achieved a clinically meaningful improvement in HAQ-DI (≥0.3 unit decrease)compared to 22% of placebo-treated patients. infliximab-tre |
