ges and an increase in developmental effects at that dose, which produced a systemic exposure 30 times the MRHD (basedon AUC comparison).
14 CLINICAL STUDIES
The safety and efficacy of once daily use of DUOBRII Lotion for the treatment of moderate to severe plaque psoriasis were assessedin two prospective, multicenter, randomized, double-blind clinical trials (Trial 1 [NCT02462070] and Trial 2 [NCT02462122]). Thesetrials were conducted in 418 subjects 18 years of age and older with moderate to severe plaque psoriasis that covered a body surface
area (BSA) between 3% and 12% excluding the face, scalp, palms, soles, axillae, and intertriginous areas. Disease severity wasdetermined by a 5-grade Investigator’s Global Assessment (IGA). Subjects applied DUOBRII Lotion or vehicle to all affected areasonce daily for up to 8 weeks. All subjects returned for a 4-week follow-up visit (12-Week visit) where safety and efficacy wereeva luated.
The primary efficacy endpoint was the proportion of subjects with “treatment success” at Week 8. Treatment success was defined asat least a 2-grade improvement from baseline in the IGA score and an IGA score equating to “clear” or “almost clear”.
Table 3 liststhe primary efficacy results for Trials 1 and 2. The secondary efficacy endpoints eva luated treatment success sequentially at Weeks
12, 6, 4, and 2. Figure 1 shows the primary and secondary efficacy results over time.
Table 3: Primary Efficacy Outcomes in Subjects with Moderate to Severe Plaque Psoriasis at Week 8
Trial 1 Trial 2
DUOBRII Vehicle DUOBRII Vehicle
N=135 N=68 N=141 N=74
IGA Treatment Success
at Week 8a
36% 7% 45% 13%
a Treatment success was defined as at least a 2-grade improvement from baseline in IGA score and an IGA score equating to “clear” or“almost clear”. Clear = no evidence of scaling, no evidence of erythema, no evidence of plaque elevation above normal skin level.
Almost clear = some plaques with fine scales, faint pink/light red erythema on most plaques, slight or barely perceptible elevation ofplaques above normal skin level.
Figure 1: Efficacy Results* over Time
*The treatment difference at Week 2 in Trial 1 was not statistically significant.
16 HOW SUPPLIED/STORAGE AND HANDLING
DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is a white to off-white lotion supplied in a white aluminumtube as follows:
• 100 g (NDC 0187-0653-01)
Storage and Handling Conditions
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from freezing.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all administrationinstructions or all possible adverse or unintended effects.
Advise patients using DUOBRII Lotion of the following information and instructions:
Important Administration Instructions
If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment.
Treatment may be resumed once irritation subsides [see Dosage and Administration (2) and Warnings and Precautions (5.2)].
Inform patients that total dosage should not exce |
