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
  • [41] Rapid Onset of Action in Patients With Moderate-to-Severe Plaque Psoriasis With Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination
    Gold, Linda Stein
    Kircik, Leon H.
    Pariser, David
    Sugarman, Jeffrey L.
    Lin, Tina
    Kang, Robert
    Pillai, Radhakrishnan
    [J]. JOURNAL OF DRUGS IN DERMATOLOGY, 2018, 17 (08) : 863 - 868
  • [42] Maintenance of skin clearance in a long-term open-label study of fixed-combination halobetasol propionate and tazarotene lotion for psoriasis in participants with prior use of topical treatments
    Gold, Linda Stein
    Alonso-Llamazares, Javier
    Zeichner, Joshua
    [J]. JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2022, 87 (03) : AB79 - AB79
  • [43] A CANADIAN NETWORK META-ANALYSIS OF THE EFFICACY OF HALOBETASOL PROPIONATE (0.01%) AND TAZAROTENE (0.045%) FIXED COMBINATION RELATIVE TO OTHER TOPICAL THERAPIES AMONG PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
    Lozano-Ortega, G.
    Rogula, B.
    Gaudet, V
    Mickle, A.
    Johnston, K.
    Barbeau, M.
    [J]. VALUE IN HEALTH, 2020, 23 : S362 - S362
  • [44] Halobetasol and Tazarotene: Further Defining the Role of a Unique Fixed Combination Topical Lotion in Moderate-to-Severe Plaque Psoriasis
    Gold, Linda Stein
    Bagel, Jerry
    Lebwohl, Mark G.
    Lin, Tina
    Martin, Gina
    Pillai, Radhakrishnan
    [J]. JOURNAL OF DRUGS IN DERMATOLOGY, 2018, 17 (12) : 1290 - 1296
  • [45] Safety and Efficacy of a Fixed Combination Halobetasol and Tazarotene Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Pooled Analysis of Two Phase 3 Studies
    Sugarman, Jeffrey L.
    Weiss, Jonathan
    Tanghetti, Emil A.
    Bagel, Jerry
    Yamauchi, Paul S.
    Gold, Linda Stein
    Lin, Tina
    Martin, Gina
    Pillai, Radhakrishnan
    Israel, Robert
    [J]. JOURNAL OF DRUGS IN DERMATOLOGY, 2018, 17 (08) : 855 - 861
  • [46] Real-world treatment outcomes with halobetasol propionate 0.01%/ tazarotene 0.045% lotion in patients with mild-to-moderate plaque psoriasis: A Canadian multicenter retrospective chart review
    Vender, Ronald
    Turchin, Irina
    Lansang, Perla
    Prajapati, Vimal H.
    Legault, Mark
    Barakat, Maxime
    Yeung, Jensen
    [J]. JAAD INTERNATIONAL, 2022, 8 : 60 - 63
  • [47] Efficacy, Safety, and Tolerability of Halobetasol Propionate 0.01%-Tazarotene 0.045% Lotion for Moderate to Severe Plaque Psoriasis in the Hispanic Population: Post Hoc Analysis
    Alexis, Andrew F.
    Yamauchi, Paul S.
    Desai, Seemal R.
    Khaselev, Nelly
    Lin, Tina
    [J]. CUTIS, 2020, 105 (03): : 150 - +
  • [48] A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis
    Kerdel, Francisco A.
    Draelos, Zoe D.
    Tyring, Stephen K.
    Lin, Tina
    Pillai, Radhakrishnan
    [J]. JOURNAL OF DERMATOLOGICAL TREATMENT, 2019, 30 (04) : 333 - 339
  • [49] Impact of body mass index (BMI) on the efficacy and safety of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in patients with plaque psoriasis
    Lebwohl, Mark G.
    Del Rosso, James Q.
    Alonso-Llamazares, Javier
    Lattouf, Mark
    Jacobson, Abby
    [J]. JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2021, 85 (03) : AB130 - AB130
  • [50] Emerging Oral Immunomodulators for the Treatment of Psoriasis: A Review of Phase III Clinical Trials for Apremilast and Tofacitinib
    McAndrew, Rachel
    Levin, Ethan
    Koo, John
    [J]. JOURNAL OF DRUGS IN DERMATOLOGY, 2015, 14 (08) : 786 - 792