Humira and placebo
Table 8. Components of Disease Activity in Study PsA-I Placebo
N=162 Humira*
N=151
Parameter: median Baseline 24 weeks Baseline 24 weeks
Number of tender jointsa 23.0 17.0 20.0 5.0
Number of swollen jointsb 11.0 9.0 11.0 3.0
Physician global assessmentc 53.0 49.0 55.0 16.0
Patient global assessmentc 49.5 49.0 48.0 20.0
Painc 49.0 49.0 54.0 20.0
Disability index (HAQ) d 1.0 0.9 1.0 0.4
CRP (mg/dL)e 0.8 0.7 0.8 0.2
* p<0.001 for Humira vs. placebo comparisons based on median changes
a Scale 0-78
b Scale 0-76
c Visual analog scale; 0=best, 100=worst
d Disability Index of the Health Assessment Questionnaire; 0=best, 3=worst; measures the patient’s ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity.
e Normal range: 0-0.287 mg/dL
Similar results were seen in an additional, 12-week study in 100 patients with moderate to severe psoriatic arthritis who had suboptimal response to DMARD therapy as manifested by ≥3 tender joints and ≥3 swollen joints at enrollment.
Radiographic Response
Radiographic changes were assessed in the PsA studies. Radiographs of hands, wrists, and feet were obtained at baseline and Week 24 during the double-blind period when patients were on Humira or placebo and at Week 48 when all patients were on open-label Humira. A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e., not identical to the TSS used for rheumatoid arthritis), was used by readers blinded to treatment group to assess the radiographs.
Humira-treated patients demonstrated greater inhibition of radiographic progression compared to placebo-treated patients and this effect was maintained at 48 weeks (see Table 9).
Table 9. Change in Modified Total Sharp Score in Psoriatic Arthritis Placebo
N=141 Humira
N=133
Week 24 Week 24 Week 48
Baseline mean 22.1 23.4 23.4
Mean Change ± SD 0.9 ± 3.1 -0.1 ± 1.7 -0.2 ± 4.9*
* <0.001 for the difference between Humira, Week 48 and Placebo, Week 24 (primary analysis)
Physical Function Response
In Study PsA-I, physical function and disability were assessed using the HAQ Disability Index (HAQ-DI) and the SF-36 Health Survey. Patients treated with 40 mg of Humira every other week showed greater improvement from baseline in the HAQ-DI score (mean decreases of 47% and 49% at Weeks 12 and 24 respectively) in comparison to placebo (mean decreases of 1% and 3% at Weeks 12 and 24 respectively). At Weeks 12 and 24, patients treated with Humira showed greater improvement from baseline in the SF-36 Physical Component Summary score compared to patients treated with placebo, and no worsening in the SF-36 Mental Component Summary score. Improvement in physical function based on the HAQ-DI was maintained for up to 84 weeks through the open-label portion of the study.
Ankylosing Spondylitis
The safety and efficacy of Humira 40 mg every other week was assessed in 315 adult patients in a randomized, 24 week double-blind, placebo-controlled study in patients with active ankylosing spondylitis (AS) who had an inadequate response to glucocorticoids, NSAIDs, analgesics, methotrexate or sulfasalazine. Active AS was defined as patients who fulfilled at least two of the following three criteria: (1) a Bath |
