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

被引:6
|
作者
Ramachandran, Vignesh [1 ,2 ]
Bertus, Brooke [1 ]
Bashyam, Arjun M. [1 ]
Feldman, Steven R. [1 ,3 ,4 ,5 ]
机构
[1] Wake Forest Sch Med, Ctr Dermatol Res, Dept Dermatol, Med Ctr Blvd, Winston Salem, NC 27157 USA
[2] Baylor Coll Med, Houston, TX 77030 USA
[3] Wake Forest Sch Med, Dept Pathol, Winston Salem, NC 27101 USA
[4] Wake Forest Sch Med, Dept Social Sci & Hlth Policy, Winston Salem, NC 27101 USA
[5] Univ Southern Denmark, Dept Dermatol, Odense, Denmark
关键词
Duobrii; psoriasis; tazarotene; halobetasol; combination; treatment; efficacy; safety; adherence; dermatology; SEVERE PLAQUE PSORIASIS; FIXED COMBINATION; 0.045-PERCENT LOTION; EFFICACY; SAFETY; 0.01-PERCENT; ADHERENCE; THERAPY; RISK; PLUS;
D O I
10.1177/1060028020910439
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
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.
引用
收藏
页码:872 / 878
页数:7
相关论文
共 50 条
  • [21] Successful Treatment of Lichen Amyloidosis Using a Fixed Combination of Halobetasol-Propionate and Tazarotene Lotion
    Shoen, Ezra
    Hou, Angela
    Zahn, Joseph
    Friedman, Adam
    [J]. JOURNAL OF DRUGS IN DERMATOLOGY, 2021, 20 (03) : 336 - 337
  • [22] Successful Management of a Black Male With Psoriasis and Dyspigmentation Treated With Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion
    Desai, Seemal R.
    Alexis, Andrew F.
    Jacobson, Abby
    [J]. JOURNAL OF DRUGS IN DERMATOLOGY, 2020, 19 (10) : 1000 - 1004
  • [23] 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
    Gold, Linda Stein
    Lebwohl, Mark G.
    Sugarman, Jeffrey L.
    Pariser, David M.
    Lin, Tina
    Martin, Gina
    Pillai, Radhakrishnan
    Israel, Robert
    Ramakrishna, Tage
    [J]. JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2018, 79 (02) : 287 - 293
  • [24] Efficacy, Safety, and Tolerability of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination in the Treatment of Severe Localized Plaque Psoriasis: Post Hoc Analysis of Two Phase III Randomized Controlled Trials
    Lebwohl, Mark G.
    Sugarman, Jeffrey L.
    Gold, Linda Stein
    Lin, Tina
    Israel, Robert
    [J]. JOURNAL OF DRUGS IN DERMATOLOGY, 2019, 18 (10) : 1012 - 1018
  • [25] Posttreatment maintenance of therapeutic effect with fixed-combination halobetasol propionate 0.01%/tazarotene 0.045% lotion for moderate-to-severe plaque psoriasis
    Lebwohl, Mark G.
    Gold, Linda Stein
    Del Rosso, James Q.
    Green, Lawrence
    Jacobson, Abby
    [J]. JOURNAL OF DERMATOLOGICAL TREATMENT, 2022, 33 (04) : 2068 - 2074
  • [26] Tildrakizumab: A Review of Phase II and III Clinical Trials
    Kolli, Sree S.
    Gabros, Sarah D.
    Pona, Adrian
    Cline, Abigail
    Feldman, Steven R.
    [J]. ANNALS OF PHARMACOTHERAPY, 2019, 53 (04) : 413 - 418
  • [27] An Open-Label Pilot Study to Investigate Safety and Efficacy of Fixed Combination Tazarotene 0.045% and Halobetasol Propionate 0.01% Lotion for the Treatment of Scalp Psoriasis
    Ozyurekoglu, Elif
    Kircik, Leon H.
    [J]. JOURNAL OF DRUGS IN DERMATOLOGY, 2021, 20 (11) : 1191 - 1194
  • [28] 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
    Sugarman, Jeffrey L.
    Gold, Linda Stein
    Lebwohl, Mark G.
    Pariser, David M.
    Alexander, Binu J.
    Pillai, Radhakrishnan
    [J]. JOURNAL OF DRUGS IN DERMATOLOGY, 2017, 16 (03) : 197 - 204
  • [29] THE COST-EFFECTIVENESS OF HALOBETASOL PROPIONATE (0.01%) AND TAZAROTENE (0.045%) FIXED COMBINATION RELATIVE TO OTHER TOPICAL THERAPIES IN MODERATE-TO-SEVERE PLAQUE PSORIASIS: A CANADIAN ANALYSIS
    Lakzadeh, P.
    Lozano-Ortega, G.
    Gaudet, V
    Johnston, K.
    Barbeau, M.
    [J]. VALUE IN HEALTH, 2019, 22 : S363 - S364
  • [30] Long-term safety results from a phase 3 open-label study of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis
    Lebwohl, Mark G.
    Sugarman, Jeffrey L.
    Gold, Linda Stein
    Pariser, David M.
    Lin, Tina
    Pillai, Radhakrishnan
    Martin, Gina
    Harris, Susan
    Israel, Robert
    [J]. JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2019, 80 (01) : 282 - 285