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In moderate to severe plaque psoriasis, the first and only retinoid-steroid.*

  • At Week 8 of treatment, 45.3% of DUOBRII patients (n=141) achieved treatment success vs vehicle (12.5% (n=74); 1° endpoint; p<0.001).1
  • 4 weeks after stopping treatment, at Week 12, 33.4% of DUOBRII patients (n=141) maintained treatment success rates vs vehicle (8.8% (n=74); 2° endpoint; p<0.001).1
The number of moderate to severe patients who demonstrated treatment success at 8 weeks, and at 4 weeks after stopping treatment (secondary endpoint)†1
Demonstrated sustained efficacy.

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Indicated for improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.
INDICATION AND CLINICAL USE:

DUOBRII is indicated for improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.
DUOBRII is not indicated for patients under the age of 18 years.
Clinical trials with DUOBRII did not include sufficient patients aged 65 and older to establish efficacy and safety in geriatric patients.

CONTRAINDICATIONS:
  • Hypersensitivity to the drug, any medicinal or non-medicinal ingredient in the formulation, any component of the container, or other corticosteroids or retinoic compounds.
  • Viral lesions of the skin, bacterial or fungal skin infections, parasitic infections, skin manifestations relating to tuberculosis or syphilis, or eruptions following vaccinations.
  • Seborrheic dermatitis.
  • Women who are pregnant or may become pregnant.
RELEVANT WARNINGS AND PRECAUTIONS:
  • Patients with skin diseases with impaired circulation
  • Patients with chronic leg ulcers
  • HPA axis suppression
  • Patients with hepatic impairment
  • Patients with impaired immune system function
  • Patients with concomitant skin infection
  • Patients with renal impairment
  • Allergic contact dermatitis
  • Patients with glaucoma
  • Striae, telangiectasias, folliculitis, or skin atrophy
  • Conditions where the skin barrier may be impaired
  • Wind or cold weather
  • Exposure to excessive sunlight or sunlamps, or to photosensitizing drugs
  • Breastfeeding women
  • DUOBRII should be used with caution as topical corticosteroid use may lead to rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity
  • Conditions that augment systemic absorption
FOR MORE INFORMATION:

Please see the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for important information on adverse reactions, drug interactions, and dosing not discussed in this piece. The Product Monograph is also available by calling 1-800-361-4261.

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Reference:
1. 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. Journal of the American Academy of Dermatology. 2018;79(2):287–93.

* Comparative clinical significance unknown.
† Based on a prospective, multicentre, randomized, double-blind, phase III clinical trial, comparing DUOBRII lotion to the vehicle lotion, in 215 patients 18 years and older with moderate to severe plaque psoriasis.
‡ Treatment success was defined as at least a 2-grade improvement from baseline in the Investigators Global Assessment (IGA) score and an IGA score equal to ‘clear’ or ‘almost clear’.

BAUSCH HEALTH

DUOBRII™ is a trademark of Bausch Health Companies Inc. or its affiliates.
Bausch Health, Canada Inc., 2150 St-Elzéar Blvd. West, Laval, Quebec  H7L 4A8
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