aïve patients with recent onset RA, the combination treatment with Humira plus MTX led to greater percentages of patients achieving ACR responses than either MTX monotherapy or Humira monotherapy at Week 52 and responses were sustained at Week 104 (see Table 4).
Table 4. ACR Response in Study RA-V (Percent of Patients) Response MTXb
N=257 Humirac
N=274 Humira/MTX
N=268
ACR20
Week 52
Week 104
63%
56%
54%
49%
73%
69%
ACR50
Week 52
Week 104
46%
43%
41%
37%
62%
59%
ACR70
Week 52
Week 104
27%
28%
26%
28%
46%
47%
Major Clinical Response a 28% 25% 49%
a Major clinical response is defined as achieving an ACR70 response for a continuous six month period
b p<0.05, Humira/MTX vs. MTX for ACR 20
p<0.001, Humira/MTX vs. MTX for ACR 50 and 70, and Major Clinical Response
c p<0.001, Humira/MTX vs. Humira
At Week 52, all individual components of the ACR response criteria for Study RA-V improved in the Humira/MTX group and improvements were maintained to Week 104.
Radiographic Response
In Study RA-III, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and Joint Space Narrowing (JSN) score, at month 12 compared to baseline. At baseline, the median TSS was approximately 55 in the placebo and 40 mg every other week groups. The results are shown in Table 5. Humira/MTX treated patients demonstrated less radiographic progression than patients receiving MTX alone at 52 weeks.
Table 5. Radiographic Mean Changes Over 12 Months in Study RA-III
Placebo/MTX Humira/MTX
40 mg every
other week Placebo/MTX-
Humira/MTX (95% Confidence
Interval*) P-value**
Total Sharp score 2.7 0.1 2.6 (1.4, 3.8) <0.001
Erosion score 1.6 0.0 1.6 (0.9, 2.2) <0.001
JSN score 1.0 0.1 0.9 (0.3, 1.4) 0.002
*95% confidence intervals for the differences in change scores between MTX and Humira.
**Based on rank analysis
In the open-label extension of Study RA-III, 77% of the original patients treated with any dose of Humira were eva luated radiographically at 2 years. Patients maintained inhibition of structural damage, as measured by the TSS. Fifty-four percent had no progression of structural damage as defined by a change in the TSS of zero or less. Fifty-five percent (55%) of patients originally treated with 40 mg Humira every other week have been eva luated radiographically at 5 years. Patients had continued inhibition of structural damage with 50% showing no progression of structural damage defined by a change in the TSS of zero or less.
In Study RA-V, structural joint damage was assessed as in Study RA-III. Greater inhibition of radiographic progression, as assessed by changes in TSS, erosion score and JSN was observed in the Humira/MTX combination group as compared to either the MTX or Humira monotherapy group at Week 52 as well as at Week 104 (see Table 6).
Table 6. Radiographic Mean Change* in Study RA-V
MTXa
N=257 Humiraa,b
N=274 Humira/MTX
N=268
52 Weeks Total Sharp score 5.7 (4.2, 7.3) 3.0 (1.7, 4.3) 1.3 (0.5, 2.1)
Erosion score 3.7 (2.7, 4.8) 1.7 (1.0, 2.4) 0.8 (0.4, 1.2)
JSN score 2.0 (1.2, 2.8) 1.3 (0.5, 2.1) 0.5 (0.0, 1.0)
104 Weeks Total Sharp score 10.4 (7. |
