AS disease activity index (BASDAI) score ≥4 cm, (2) a visual analog score (VAS) for total back pain ≥ 40 mm, and (3) morning stiffness ≥ 1 hour. The blinded period was followed by an open-label period during which patients received Humira 40 mg every other week subcutaneously for up to an additional 28 weeks.
Improvement in measures of disease activity was first observed at Week 2 and maintained through 24 weeks as shown in Figure 2 and Table 10.
Responses of patients with total spinal ankylosis (n=11) were similar to those without total ankylosis.
At 12 weeks, the ASAS 20/50/70 responses were achieved by 58%, 38%, and 23%, respectively, of patients receiving Humira, compared to 21%, 10%, and 5% respectively, of patients receiving placebo (p <0.001). Similar responses were seen at Week 24 and were sustained in patients receiving open-label Humira for up to 52 weeks.
A greater proportion of patients treated with Humira (22%) achieved a low level of disease activity at 24 weeks (defined as a value <20 [on a scale of 0 to 100 mm] in each of the four ASAS response parameters) compared to patients treated with placebo (6%).
Table 10. Components of Ankylosing Spondylitis Disease Activity Placebo
N=107 Humira
N=208
Baseline mean Week 24 mean Baseline mean Week 24 mean
ASAS 20 Response Criteria*
Patient’s Global Assessment of Disease Activitya* 65 60 63 38
Total back pain* 67 58 65 37
Inflammationb* 6.7 5.6 6.7 3.6
BASFIc* 56 51 52 34
BASDAId score* 6.3 5.5 6.3 3.7
BASMIe score* 4.2 4.1 3.8 3.3
Tragus to wall (cm) 15.9 15.8 15.8 15.4
Lumbar flexion (cm) 4.1 4.0 4.2 4.4
Cervical rotation (degrees) 42.2 42.1 48.4 51.6
Lumbar side flexion (cm) 8.9 9.0 9.7 11.7
Intermalleolar distance (cm) 92.9 94.0 93.5 100.8
CRPf* 2.2 2.0 1.8 0.6
a Percent of subjects with at least a 20% and 10-unit improvement measured on a Visual Analog Scale (VAS) with 0 = “none” and 100 = “severe”
b mean of questions 5 and 6 of BASDAI (defined in ‘d’)
c Bath Ankylosing Spondylitis Functional Index
d Bath Ankylosing Spondylitis Disease Activity Index
e Bath Ankylosing Spondylitis Metrology Index
f C-Reactive Protein (mg/dL)
* statistically significant for comparisons between Humira and placebo at Week 24
A second randomized, multicenter, double-blind, placebo-controlled study of 82 patients with ankylosing spondylitis showed similar results.
Patients treated with Humira achieved improvement from baseline in the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) score (-3.6 vs. -1.1) and in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) score (7.4 vs. 1.9) compared to placebo-treated patients at Week 24.
Crohn’s Disease
The safety and efficacy of multiple doses of Humira were assessed in adult patients with moderately to severely active Crohn’s disease, CD, (Crohn’s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomized, double-blind, placebo-controlled studies. Concomitant stable doses of aminosalicylates, corticosteroid |
