nt Questionnaire (HAQ).1 Additionally, in Study III, patients were administered the SF-362 Health Survey. In Studies I and II, patients treated with 25 mg ENBREL® twice weekly showed greater improvement from baseline in the HAQ score beginning in month 1 through month 6 in comparison to placebo (p < 0.001) for the HAQ disability domain (where 0 = none and 3 = severe). In Study I, the mean improvement in the HAQ score from baseline to month 6 was 0.6 (from 1.6 to 1.0) for the 25 mg ENBREL® group and 0 (from 1.7 to 1.7) for the placebo group. In Study II, the mean improvement from baseline to month 6 was 0.6 (from 1.5 to 0.9) for the ENBREL®/MTX group and 0.2 (from 1.3 to 1.2) for the placebo/MTX group. In Study III, the mean improvement in the HAQ score from baseline to month 6 was 0.7 (from 1.5 to 0.7) for 25 mg ENBREL® twice weekly. All subdomains of the HAQ in Studies I and III were improved in patients treated with ENBREL®.
In Study III, patients treated with 25 mg ENBREL® twice weekly showed greater improvement from baseline in SF-36 physical component summary score compared to ENBREL® 10 mg twice weekly and no worsening in the SF-36 mental component summary score. In open-label ENBREL® studies, improvements in physical function and disability measures have been maintained for up to 4 years.
In Study IV, median HAQ scores improved from baseline levels of 1.8, 1.8, and 1.8 to 1.1, 1.0, and 0.6 at 12 months in the MTX, ENBREL®, and ENBREL®/MTX combination treatment groups, respectively (combination versus both MTX and ENBREL®, p < 0.01). Twenty-nine percent of patients in the MTX alone treatment group had an improvement of HAQ of at least one unit versus 40% and 51% in the ENBREL® alone and the ENBREL®/MTX combination treatment groups, respectively.
Radiographic Response
In Study 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. Radiographs of hands/wrists and forefeet were obtained at baseline, 6 months, 12 months, and 24 months and scored by readers who were unaware of treatment group. The results are shown in Table 4. A significant difference for change in erosion score was observed at 6 months and maintained at 12 months.
Table 4: Mean Radiographic Change Over 6 and 12 Months in Study III *
95% confidence intervals for the differences in change scores between MTX and ENBREL ®.
MTX 25 mg ENBREL® MTX/ENBREL®
(95% Confidence Interval*) P-value
12 Months Total Sharp score 1.59 1.00 0.59 (-0.12, 1.30) 0.1
Erosion score 1.03 0.47 0.56 (0.11, 1.00) 0.002
JSN score 0.56 0.52 0.04 (-0.39, 0.46) 0.5
6 Months Total Sharp score 1.06 0.57 0.49 (0.06, 0.91) 0.001
Erosion score 0.68 0.30 0.38 (0.09, 0.66) 0.001
JSN score 0.38 0.27 0.11 (-0.14, 0.35) 0.6
Patients continued on the therapy to which they were randomized for the second year of Study III. Seventy-two percent of patients had x-rays obtained at 24 months. Compared to the patients in the MTX group, greater inhibition of progression in TSS and erosion score was seen in the 25 mg ENBREL® group, and in addition, less progression was noted in the JSN score.
In the open-label extension of Study III, 48% of the original patients treated with 25 mg ENBREL® have been eva luated radiographically at 5 years. Patients had continued inhibition of structural damage, as measured by the TSS, and 55% of t |
