mized to 20 mg/week by week 8), Humira 40 mg every other week or Humira/MTX combination therapy for 104 weeks. Patients were eva luated for signs and symptoms, and for radiographic progression of joint damage. The median disease duration among patients enrolled in the study was 5 months. The median MTX dose achieved was 20 mg.
Clinical Response
The percent of Humira treated patients achieving ACR 20, 50 and 70 responses in Studies RA-II and III are shown in Table 2.
Table 2. ACR Responses in Studies RA-II and RA-III (Percent of Patients)
Study RA-II
Monotherapy
(26 weeks) Study RA-III
Methotrexate Combination
(24 and 52 weeks)
Response Placebo Humira Humira Placebo/MTX Humira/MTX
40 mg every 40 mg weekly 40 mg every
other week other week
N=110 N=113 N=103 N=200 N=207
ACR20
Month 6 19% 46%* 53%* 30% 63%*
Month 12 NA NA NA 24% 59%*
ACR50
Month 6 8% 22%* 35%* 10% 39%*
Month 12 NA NA NA 10% 42%*
ACR70
Month 6 2% 12%* 18%* 3% 21%*
Month 12 NA NA NA 5% 23%*
The results of Study RA-I were similar to Study RA-III; patients receiving Humira 40 mg every other week in Study RA-I also achieved ACR 20, 50 and 70 response rates of 65%, 52% and 24%, respectively, compared to placebo responses of 13%, 7% and 3% respectively, at 6 months (p<0.01).
The results of the components of the ACR response criteria for Studies RA-II and RA-III are shown in Table 3. ACR response rates and improvement in all components of ACR response were maintained to week 104. Over the 2 years in Study RA-III, 20% of Humira patients receiving 40 mg every other week (EOW) achieved a major clinical response, defined as maintenance of an ACR 70 response over a 6-month period. ACR responses were maintained in similar proportions of patients for up to 5 years with continuous Humira treatment in the open-label portion of Study RA-III.
Table 3. Components of ACR Response in Studies RA-II and RA-III
Study RA-II Study RA-III
Parameter (median) Placebo
N=110 Humiraa
N=113 Placebo/MTX
N=200 Humiraa/MTX
N=207
Baseline Wk 26 Baseline Wk 26 Baseline Wk 24 Baseline Wk 24
Number of tender joints (0-68) 35 26 31 16* 26 15 24 8*
Number of swollen joints (0-66) 19 16 18 10* 17 11 18 5*
Physician global assessmentb 7.0 6.1 6.6 3.7* 6.3 3.5 6.5 2.0*
Patient global assessmentb 7.5 6.3 7.5 4.5* 5.4 3.9 5.2 2.0*
Painb 7.3 6.1 7.3 4.1* 6.0 3.8 5.8 2.1*
Disability index (HAQ)c 2.0 1.9 1.9 1.5* 1.5 1.3 1.5 0.8*
CRP (mg/dL) 3.9 4.3 4.6 1.8* 1.0 0.9 1.0 0.4*
a 40 mg Humira administered every other week
b Visual analogue scale; 0 = best, 10 = worst
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
* p<0.001, Humira vs. placebo, based on mean change from baseline
In Study RA-IV, 53% of patients treated with Humira 40 mg every other week plus standard of care had an ACR 20 response at week 24 compared to 35% on placebo plus standard of care (p<0.001). No unique adverse reactions related to the combination of Humira (adalimumab) and other DMARDs were observed.
In Study RA-V with MTX n |
