Protopic (Page 2 of 6)

CLINICAL STUDIES

Three randomized, double-blind, vehicle-controlled, multi-center, phase 3 studies were conducted to evaluate Protopic® Ointment for the treatment of patients with moderate to severe atopic dermatitis. One (Pediatric) study included 351 patients 2-15 years of age, and the other two (Adult) studies included a total of 632 patients 15-79 years of age. Fifty-five percent (55%) of the patients were women and 27% were black. At baseline, 58% of the patients had severe disease and the mean body surface area (BSA) affected was 46%. Over 80% of patients had atopic dermatitis affecting the face and/or neck region. In these studies, patients applied either Protopic® Ointment 0.03%, Protopic® Ointment 0.1%, or vehicle ointment twice daily to 10% — 100% of their BSA for up to 12 weeks.

In the pediatric study, a significantly greater (p < 0.001) percentage of patients achieved at least 90% improvement based on the physician’s global evaluation of clinical response (the pre-defined primary efficacy endpoint) in the Protopic® Ointment 0.03% treatment group compared to the vehicle treatment group, but there was insufficient evidence that Protopic® Ointment 0.1% provided more efficacy than Protopic® Ointment 0.03%.

In both adult studies, a significantly greater (p < 0.001) percentage of patients achieved at least 90% improvement based on the physician’s global evaluation of clinical response in the Protopic® Ointment 0.03% and Protopic® ​ Ointment 0.1% treatment groups compared to the vehicle treatment group. There was evidence that Protopic® Ointment 0.1% may provide more efficacy than Protopic® Ointment 0.03%. The difference in efficacy between Protopic® Ointment 0.1% and 0.03% was particularly evident in adult patients with severe disease at baseline, 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 Evaluation 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 evaluation 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 2
(click image for full-size original)

Figure 2 — Pediatric Patients Body Surface Area Over Time

Figure 3
(click image for full-size original)

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 4
(click image for full-size original)

Figure 4 — Pediatric Patients Mean Erythema Over Time

Figure 5
(click image for full-size original)

The time course of improvement in the remaining secondary efficacy variables was similar to that of erythema, with improvement in lichenification slightly slower.

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