Treating Psoriasis With Halobetasol Propionate and Tazarotene Combination: A Review of Phase II and III Clinical Trials

Ann Pharmacother. 2020 Sep;54(9):872-878. doi: 10.1177/1060028020910439. Epub 2020 Mar 4.

Abstract

Objective: To review phase II and III clinical trial data to evaluate the efficacy and safety of the halobetasol propionate/tazarotene (HP/TAZ) combination lotion (Duobrii), a medication approved by the Food and Drug Administration in April 2019 for adults with plaque psoriasis. Data Sources: A systematic search (January 2005 to July 2019) of MEDLINE (PubMed) and EMBASE databases was performed using the terms halobetasol, tazarotene, halobetasol/tazarotene, Duobrii, and IDP-118. Study Selection and Data Extraction: Relevant English-language articles reporting on phase II and phase III clinical trials were included. Data from the individual trials were extracted independently and then cross-checked to ensure accuracy. Data Synthesis: HP/TAZ was safe and efficacious compared with HP alone, TAZ alone, or vehicle. More patients achieved treatment success, described as a ≥2-grade improvement on Investigator Global Assessment Scale, over 8 weeks of treatment and at the 4-week follow-up after treatment cessation. The most common adverse events were dermatitis, pain, and pruritus, which occurred more often in the TAZ groups compared with the HP/TAZ cohorts. Relevance to Patient Care and Clinical Practice: The once-daily HP/TAZ combination lotion simplifies psoriasis treatment and may facilitate adherence, which may improve psoriasis outcomes. Conclusions: HP/TAZ combination lotion is efficacious and safe for plaque psoriasis treatment, with more patients achieving end points and fewer side effects than in HP, TAZ, or vehicle-treated controls. Drug synergy may play a role. Importantly, patient adherence to a once-daily combinational therapy is likely to contribute to efficacy.

Keywords: Duobrii; adherence; combination; dermatology; efficacy; halobetasol; psoriasis; safety; tazarotene; treatment.

Publication types

  • Systematic Review

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Clobetasol / administration & dosage
  • Clobetasol / adverse effects
  • Clobetasol / analogs & derivatives*
  • Clobetasol / therapeutic use
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / therapeutic use*
  • Drug Combinations
  • Drug Synergism
  • Humans
  • Nicotinic Acids / administration & dosage
  • Nicotinic Acids / adverse effects
  • Nicotinic Acids / therapeutic use*
  • Pain / chemically induced
  • Pruritus / chemically induced
  • Psoriasis / drug therapy*
  • Severity of Illness Index
  • Skin Cream
  • Treatment Outcome
  • United States

Substances

  • Dermatologic Agents
  • Drug Combinations
  • Nicotinic Acids
  • tazarotene
  • halobetasol
  • Clobetasol