Phase 3 clinical trials

Significant topical efficacy with extended remission 4 weeks post treatment1,2

 
Patients with treatment success* (8 week primary endpoint)
Study Design
Superior clearance at primary endpoint in both trials (P<0.001%)2

Only topical combination for psoriasis with proven remission data (P<0.001%)2

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

Post hoc analysis of a phase 2 clinical trial

Proven synergy: superior efficacy vs the aggregated results of two monotherapies3,4

 
Treatment success at 8 weeks with the effect of vehicle removed3,4
Study Design
Treatment success was defined as at least a 2-grade improvement from baseline in the IGA score, and a score of “clear” or “almost clear” (primary endpoint at week 8).3
More patients experienced treatment success with DUOBRII Lotion than the aggregated success rates of both monotherapies3, 4

DUOBRII Lotion exceeded the clinical definition of synergy by 31.7% at 8 weeks3,4

Synergy, as defined by the National Cancer Institute, is an interaction between 2 or more drugs that creates a combined result that is greater than the sum of the effects when each drug is given alone5

Post hoc analysis of a long-term safety study:

DUOBRII Lotion delivered extended remission up to 3 months post treatment6

 
Patients with a baseline BSA of 3%-12% who achieved and also maintained treatment success‡§
Adverse events seen in a long-term safety study through
8 weeks were consistent with those seen in the phase 3 studies
  • Rate of epidermal atrophy during the long-term study was 0.7%
  • The percentage of subjects with reported adverse events at 8 weeks did not increase throughout the rest of the study
  • Some individuals may experience atrophy, striae, telangiectasias, and folliculitis.
    If these effects occur, discontinue until the integrity of the skin has been restored1

Treatment success defined as at least a 2-grade improvement from baseline in the IGA score, and an IGA score of “clear” or “almost clear.” Retreatment when IGA was at 2-mild.6
§Patients achieved treatment success at any point during the study.6

Study Design

Phase 2 clinical trial

At week 2, patients using DUOBRII Lotion achieved similar clearance to Ultravate cream, with less steroid exposure6

 
Efficacy results observed in a 2-week QD study
Study Design
Treatment success was defined as at least a 2-grade improvement from baseline in the IGA score, and a score of “clear” or “almost clear” (primary endpoint at week 8).6

QD = once daily
Patients were exposed to 400% more corticosteroid with Ultravate cream than with DUOBRII Lotion6

Indication

DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is indicated for the topical treatment of plaque psoriasis in adults.

Important Safety Information

Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

Warnings and Precautions
  • Women of child-bearing potential should be warned of the potential risk of fetal harm from DUOBRII and use adequate birth-control. A negative result for pregnancy should be obtained within 2 weeks prior to treatment. If the patient becomes pregnant during treatment, discontinue DUOBRII Lotion and advise patient of the potential hazard to the fetus.
  • DUOBRII Lotion has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis during or after treatment and may require that patients be evaluated periodically during treatment.
  • Predisposing factors for HPA axis suppression include: use of more potent corticosteroids, use on large areas, use under occlusive dressings, use on altered skin barrier, concomitant use of other steroids, liver failure and young age.
  • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria.
  • Local adverse reactions may include atrophy, striae, telangiectasias, folliculitis and contact dermatitis. If these effects occur, discontinue until the integrity of the skin has been restored. Do not resume treatment if contact dermatitis is identified. DUOBRII Lotion should not be used on eczematous skin, as it may cause severe irritation.
  • Avoid exposure to sunlight, sunlamps and weather extremes. Patients with sunburn should be advised not to use DUOBRII Lotion until fully recovered. DUOBRII Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers because of the increased potential for photosensitivity.
  • Topical corticosteroids may increase the risk of cataracts and glaucoma; advise patients to report any visual symptoms and refer to an ophthalmologist if needed.
Adverse Events
  • The most common adverse events in clinical trials were contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%).

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.

Please click here for full Prescribing Information.

References: 1. DUOBRII Lotion [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC. 2. Gold LS, Lebwohl MG, Sugarman JL, et al. Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: results of 2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2018;79(2):287-293. 3. Sugarman JL, Gold LS, Lebwohl MG, et al. A phase 2, multicenter, double-blind, randomized, vehicle controlled clinical study to assess the safety and efficacy of a halobetasol/tazarotene fixed combination in the treatment of plaque psoriasis. J Drugs Dermatol. 2017;16(3):611-618. 4. Kircik LH, Papp KA, Gold LS, Harris S, Lin T, Pillai R. Assessing the synergistic effect of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis. J Drugs Dermatol. 2019;18(3):279-284. 5. National Cancer Institute. Synergistic. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/synergistic. Accessed December 4, 2018. 6. Data on file.

INDICATION

IMPORTANT SAFETY INFORMATION

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DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is indicated for the topical treatment of plaque psoriasis in adults.

IMPORTANT SAFETY INFORMATION

Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

DUOBRII Lotion is contraindicated in pregnancy.