, adults with extensive BSA involvement, and black adults. Response rates for each treatment group are shown below by age groups. Because the two adult studies were identically designed, the results from these studies were pooled in this table.
Global Improvement over Baseline at the End-Of-Treatment in Three Phase 3 Studies
Physician’s Global eva luation of Clinical Response
(% Improvement)
Pediatric Study (2-15
Years of Age) Adult Studies
Vehicle
Ointment
N = 116
PROTOPIC Ointment
0.03%
N = 117
Vehicle Ointment
N = 212
PROTOPIC Ointment
0.03%
N = 211
PROTOPIC Ointment
0.1%
N = 209
100% 4 (3%) 14 (12%) 2 (1%) 21 (10%) 20 (10%)
≥ 90% 8 (7%) 42 (36%) 14 (7%) 58 (28%) 77 (37%)
≥ 75% 18 (16%) 65 (56%) 30 (14%) 97 (46%) 117 (56%)
≥ 50% 31 (27%) 85 (73%) 42 (20%) 130 (62%) 152 (73%)
A statistically significant difference in the percentage of adult patients with ≥ 90% improvement was achieved by week 1 for those treated with PROTOPIC Ointment 0.1%, and by week 3 for those treated with PROTOPIC Ointment 0.03%. A statistically significant difference in the percentage of pediatric patients with ≥ 90% improvement was achieved by week 2 for those treated with PROTOPIC Ointment 0.03%.
In adult patients who had achieved ≥ 90% improvement at the end of treatment, 35% of those treated with PROTOPIC Ointment 0.03% and 41% of those treated with PROTOPIC Ointment 0.1%, regressed from this state of improvement at 2 weeks after end-of-treatment. In pediatric patients who had achieved ≥ 90% improvement, 54% of those treated with PROTOPIC Ointment 0.03% regressed from this state of improvement at 2 weeks after end-of-treatment. Because patients were not followed for longer than 2 weeks after end-of-treatment, it is not known how many additional patients regressed at periods longer than 2 weeks after cessation of therapy.
In both PROTOPIC Ointment treatment groups in adults and in the PROTOPIC Ointment 0.03% treatment group in pediatric patients, a significantly greater improvement compared to vehicle (p < 0.001) was observed in the secondary efficacy endpoints of percent body surface area involved, patient eva luation of pruritus, erythema, edema, excoriation, oozing, scaling, and lichenification. The following two graphs depict the time course of improvement in the percent body surface area affected in adult and in pediatric patients as a result of treatment.
Figure 1 - Adult Patients Body Surface Area Over Time
Figure 1 - Adult Patients Body Surface Area Over Time
Figure 2 - Pediatric Patients Body Surface Area Over Time
Figure 2 – Pediatric Patients Body Surface Area Over Time
The following two graphs depict the time course of improvement in erythema in adult and in pediatric patients as a result of treatment.
Figure 3 - Adult Patients Mean Erythema Over Time
Figure 3 - Adult Patients Mean Erythema Over Time
Figure 4 - Pediatric Patients Mean Erythema Over Time
Figure 4 - Pediatric Patients Mean Erythema Over Time
The time course of improvement in the remaining secondary efficacy variables was similar to that of erythema, with improvement in lichenification slightly slower.
INDICATIONS AND USAGE
PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 1 |
