EFFICACY

TWO PHASE 3 TRIALS

Class 1 efficacy at week 8, when applied once daily, with continued results 4 weeks post treatment1-3

Line chart comparing patients with treatment success between BRYHALI Lotion and vehicle between two clinical trials
SEE THE STUDY DESIGN
 

Study Design

The safety and efficacy of BRYHALI Lotion were assessed in 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of 'clear' or 'almost clear' evaluated at week 8. Secondary efficacy endpoint was treatment success evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement in IGA from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling).1-3

†Treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of 'clear' or 'almost clear' at week 8 primary endpoint.1,2

‡The treatment difference at week 2 in trial 2 was not statistically significant.1,2

SIGNIFICANT CLEARANCE WITH LOW STEROID EXPOSURE4,5

  • An average of 37.4% of patients had treatment success at week 8 vs 10.0% for vehicle (P<0.001 from trials 1 and 2)4
  • The only single-agent low-concentration halobetasol (0.01%) formulation5

POST-HOC ANALYSIS OF POOLED DATA: TWO PHASE 3 TRIALS

Safety Findings

  • There were no instances of treatment-emergent epidermal atrophy reported in either the BRYHALI Lotion or vehicle groups. There was an average of 0.8% of patients in each group who had epidermal atrophy at baseline that persisted through week 83,4
  • See additional tolerability data for itching, irritation, and dryness
  • Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, hypopigmentation, and allergic contact dermatitis. Some local adverse reactions may be irreversible1

POST-HOC ANALYSIS OF POOLED DATA: TWO PHASE 3 TRIALS

Tertiary endpoint results: Erythema, plaque elevation, and scaling at weeks 2 and 83,4

Bar chart comparing the percent of patients with 2-grade baseline improvement in inflammation, plaque elevation, and scaling between BRYHALI Lotion and Vehicle Lotion
SEE THE STUDY DESIGN
 

Study Design

Post-hoc, pooled analysis of data from 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success evaluated at week 8. Secondary efficacy endpoint was treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of 'clear' or 'almost clear' evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement in IGA from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling).1,3,4

Deliver the relief they need for up to 8 weeks with continuous use of BRYHALI Lotion.

  • Discontinue treatment if control is achieved before 8 weeks

Improvement in psoriasis signs at each study visit

  • Differences seen by week 2 for erythema and scaling and by week 4 for plaque elevation, and were maintained through week 123,4

Limitations

  • Data from pooled analyses of tertiary endpoints should be interpreted in the context of the results of the primary endpoints of the separate phase 3 trials.
  • In pivotal trials, the secondary efficacy endpoints evaluating treatment success at week 2 in trial 2 was not statistically significant

See tolerability data for itching, irritation, and dryness

BEFORE AND AFTER

Set a course to Class 1 clearance1,3

Female aged 43 years treated once daily with BRYHALI Lotion
After (8 weeks)
Before (Baseline)
Individual results may vary.

These photos represent actual clinical experience. Photos have not been retouched.

Set a course to Class 1 clearance1,3

Female aged 45 years treated once daily with BRYHALI Lotion
After (8 weeks)
Before (Baseline)
Individual results may vary.

These photos represent actual clinical experience. Photos have not been retouched.

Set a course to Class 1 clearance1,3

Male aged 40 years treated once daily with BRYHALI Lotion
After (8 weeks)
Before (Baseline)
Individual results may vary.

These photos represent actual clinical experience. Photos have not been retouched.

SAFETY

TWO PHASE 3 TRIALS

Chart a course to symptomatic relief: safety and tolerability findings

Adverse reactions in phase 3 clinical studies

  • To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576, or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch

Warnings and Precautions

  • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur with the potential for glucocorticosteroid insufficiency during or after treatment
  • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria
  • Systemic absorption may require evaluation for HPA axis suppression
  • Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure
  • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids
  • Local adverse reactions may include atrophy, striae, telangiectasias, hypopigmentation, and allergic contact dermatitis. Some local adverse reactions may be irreversible
  • Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation

Pooled analysis of patients using BRYHALI Lotion in Two phase 3 trials revealed:

  • No serious treatment-related adverse events3
  • Only 1.8% of patients reported drug-related adverse events with BRYHALI Lotion vs 2.8% for vehicle4
  • BRYHALI Lotion: No treatment-emergent epidermal atrophy observed through 8 weeks of treatment in either the BRYHALI Lotion or vehicle groups. There was an average of 0.8% of patients in each group who had epidermal atrophy at baseline that persisted through week 83
  • Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, hypopigmentation, and allergic contact dermatitis. Some local adverse reactions may be irreversible1
SEE THE STUDY DESIGN

Study Design

Post-hoc, pooled analysis of data from 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of 'clear' or 'almost clear' evaluated at week 8. Secondary efficacy endpoint was treatment success evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement in IGA from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling).1,3,4
Allergic contact dermatitis1

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue BRYHALI Lotion if allergic contact dermatitis occurs.

POST-HOC ANALYSIS OF POOLED DATA: TWO PHASE 3 TRIALS

Tolerability assessment: local skin reactions3

Patients with moderate-to-severe local skin reactions at baseline

Bar chart comparing the percent reduction in itching, dryness, and irritaion from baseline between BRYHALI Lotion and Vehicle Lotion
SEE THE STUDY DESIGN

Study Design

Post-hoc, pooled analysis of data from 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of 'clear' or 'almost clear' evaluated at week 8. Secondary efficacy endpoint was treatment success evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement in IGA from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling). Local skin reactions were evaluated using a 4-point scale from 0 (clear) to 3 (severe).1,3,4

‡‡Reported as burning/stinging in both phase 3 clinical trials.2

Reductions in itching of 45.81% and 60.0% at 2 and 8 weeks, respectively, vs 18.24% and 23.65% for vehicle3

Similar reductions also seen in irritation and dryness3

See efficacy data for inflammation, plaque elevation, and scaling

POST-HOC ANALYSIS OF POOLED DATA: TWO PHASE 3 TRIALS

Tolerability assessment: epidermal atrophy3,4

  • In a pooled analysis of Two phase 3 trials, there was no treatment-emergent epidermal atrophy in either the BRYHALI Lotion or vehicle groups. An average of 0.8% of patients in each group had epidermal atrophy at baseline that persisted through week 83
  • Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, hypopigmentation, and allergic contact dermatitis. Some local adverse reactions may be irreversible1
SEE THE STUDY DESIGN

Study Design

Post-hoc, pooled analysis of data from 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of 'clear' or 'almost clear' evaluated at week 8. Secondary efficacy endpoint was treatment success evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement in IGA from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling).1,3,4

VEHICLE FEATURES

Micron-sized emulsion droplets designed for optimal delivery

Transmission electron micrograph of BRYHALI Lotion. Magnified 1,000 times.

Strengthened barrier function and increased moisture retention 24-hr study3

Skin barrier function as measured study by Tewameter®

Line chart comparing skin barrier function as measured study by tewameter between BRYHALI Lotion vehicle and an untreated control site

Skin hydration as measured by Corneometer®

Line chart showing skin hydration as measured by a corneometer of BRYHALI Lotion vehicle treated site vs an untreated control site
SEE THE STUDY DESIGN
 

Study Design

The trans-epidermal water loss (TEWL) and moisture content of skin sites treated with BRYHALI Lotion vehicle vs untreated sites were measured in 30 healthy female volunteers at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 8 hours, and 24 hours. Evaluations were made by a trained technician using the Tewameter® and Corneometer®.3

100% of patients (N=15) in a satisfaction survey somewhat or strongly agreed that the BRYHALI Lotion vehicle:3

ABSORBED QUICKLY
DID NOT LEAVE SKIN FEELING GREASY
HAD A LIGHTWEIGHT FEEL AFTER APPLICATION

Individual results may vary

SEE THE STUDY DESIGN
 

Study Design

Fifteen healthy female volunteers assessed the customer perception and satisfaction of the BRYHALI Lotion vehicle. Each subject applied the lotion vehicle to one side of the face while leaving the other side untreated. Subjects then answered a questionnaire about various attributes of the product after application to assess their satisfaction.3

Chart a course to once-daily dosing in 2 sizes1

60g60g Tube
100g100g Tube

Additional dosing considerations

  • Patients should rub in gently and wash hands after each application unless specifically treating hands
  • Total dosage should not exceed approximately 50g/week
  • Treatment beyond 8 weeks is not recommended
  • Discontinue treatment if control is achieved before 8 weeks
  • Patients should not use occlusive dressings unless directed to do so by their HCPs

Savings offer for most eligible commercially insured patients*:

SEE HOW PATIENTS CAN SAVE

As little as a $65 co-pay for eligible patients whose commercial insurance does not cover BRYHALI Lotion†

 

ELIGIBILITY CRITERIA AND TERMS AND CONDITIONS

*This offer is only valid for patients with commercial insurance. Uninsured patients are not eligible for this savings offer. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including but not limited to Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration, or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is good only in the U.S. at retail pharmacies owned and operated by Walgreen Co. (or its affiliates) or other participating independent retail pharmacies. This offer is not valid where otherwise prohibited, taxed, or otherwise restricted. Click here for full eligibility terms and conditions.

†Insured not covered is defined as a patient who has commercial insurance but the drug is not covered on the plan’s formulary or has an NDC block, prior authorization, step edit or other restriction that has not been met.