Dataset Information

Safety and Efficacy of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination Lotion in the Treatment of Moderate-to-severe Plaque Psoriasis: A Comparison with Halobetasol Propionate 0.05% Cream.

ABSTRACT: Background: Topical corticosteroids (TCS) represent a mainstay of psoriasis treatment, though more potent formulations are not recommended for use for more than 2 to 4 weeks. Objective: We sought to investigate the safety and efficacy of once-daily halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion and halobetasol propionate 0.05% cream in patients with moderate-to-severe plaque psoriasis. Methods: This was a multicenter, randomized, double-blind, parallel-group, vehicle-controlled Phase II study (n=154). Patients were randomized (2:2:1) to HP 0.01%/TAZ 0.045% lotion, halobetasol propionate 0.05% cream, or vehicle, applied topically once daily for two weeks. Efficacy assessments included treatment success, impact on individual psoriasis signs (i.e., erythema, plaque elevation, and scaling) at target lesion, and body surface area (BSA). Safety and adverse events (AEs) were evaluated throughout. Results: HP/TAZ lotion was significantly more effective than vehicle and was comparable to halobetasol propionate 0.05% cream in reducing erythema, plaque elevation, and scaling. Of the HP/TAZ patients, 32.8 percent achieved treatment success versus 34.0 and 3.3 percent in the halobetasol and vehicle groups. At Week 2, treatment success was seen in 34.4 percent (erythema), 54.1 percent (plaque elevation), and 60.7 percent (scaling) of patients versus in 43.5, 50.8, and 50.8 percent receiving halobetasol. A 25.0- and 24.8-percent reduction in BSA occurred, respectively. The most frequently reported, treatment-related AE was application site pain. Conclusions: The efficacy of HP/TAZ lotion was comparable to a higher concentration of 0.05% halobetasol cream, showing rapid treatment success after two weeks with good safety.

SUBMITTER: Bhatia ND

PROVIDER: S-EPMC6303116 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Safety and Efficacy of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination Lotion in the Treatment of Moderate-to-severe Plaque Psoriasis: A Comparison with Halobetasol Propionate 0.05% Cream.

Bhatia Neal D ND Pariser David M DM Kircik Leon L Lin Tina T Harris Susan S Mathew Lindsey L Pillai Radhakrishnan R

The Journal of clinical and aesthetic dermatology 20181101 11

Background: Topical corticosteroids (TCS) represent a mainstay of psoriasis treatment, though more potent formulations are not recommended for use for more than 2 to 4 weeks. Objective: We sought to investigate the safety and efficacy of once-daily halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion and halobetasol propionate 0.05% cream in patients with moderate-to-severe plaque psoriasis. Methods: This was a multicenter, randomized, double-blind, parallel-group, ...[more]

PMID: 30588269

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Project description:IntroductionTo date, there have been no head-to-head clinical studies comparing calcipotriol 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam and halobetasol propionate 0.01% plus tazarotene 0.045% (HP/Taz) lotion for the treatment of plaque psoriasis. However, the efficacy of 4 weeks of Cal/BD foam and 8 weeks of HP/Taz lotion has been compared using a matching-adjusted indirect comparison (MAIC) approach. Here, we compare the efficacy and safety of Cal/BD foam and HP/Taz lotion for up to 52 weeks.MethodsAn unanchored MAIC was conducted using individual patient data from the PSO-LONG Cal/BD foam trial and a 52-week, open-label phase 3 study of HP/Taz lotion (NCT02462083). Key outcomes of interest were Physician's Global Assessment (PGA) success (PGA 0/1 with ≥ 2-point improvement) after 4 or 8 weeks of open-label therapy; the proportion of patients who had body surface area affected (BSA) ≤ 3 after open-label therapy who maintained BSA ≤ 3 to week 52; and adverse events (AEs).ResultsAfter matching, patients were statistically significantly more likely to have PGA success after 4 weeks of Cal/BD foam than after 8 weeks of HP/Taz lotion (84.5% versus 54.4%; p < 0.01). At week 52, 92.5% and 92.4% of patients receiving proactive and reactive Cal/BD foam, respectively, maintained BSA ≤ 3, compared with 49.3% of those treated with HP/Taz lotion (both p < 0.01). Treatment-related AEs, AEs leading to withdrawal, and AEs associated with drug application (dermatitis, application site pain, and pruritus) were significantly rarer with Cal/BD foam than with HP/Taz lotion (all p < 0.01).ConclusionsCal/BD aerosol foam demonstrated significantly greater efficacy than HP/Taz lotion, and had a more favorable safety profile, compared with HP/Taz lotion, for up to 52 weeks. Proactive Cal/BD foam maintenance therapy and reactive use of Cal/BD foam following relapse both had significant advantages over HP/Taz lotion.

Project description:ImportanceOnce-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis.ObjectiveTo evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis.Design, setting, and participantsTwo phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively.InterventionsPatients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks.Main outcomes and measuresThe primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points).ResultsAmong 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P < .001 for both). Of 9 secondary end points, statistically significant differences favoring roflumilast vs vehicle were observed for 8 in trial 1 and 9 in trial 2, including intertriginous IGA success (71.2% vs 13.8%; difference, 66.5% [95% CI, 47.1%-85.8%] and 68.1% vs 18.5%; difference, 51.6% [95% CI, 29.3%-73.8%]; P < .001 for both), 75% reduction in PASI score (41.6% vs 7.6%; difference, 36.1% [95% CI, 28.5%-43.8%] and 39.0% vs 5.3%; difference, 32.4% [95% CI, 24.9%-39.8%]; P < .001 for both), WI-NRS success (67.5% vs 26.8%; difference, 42.6% [95% CI, 31.3%-53.8%] and 69.4% vs 35.6%; difference, 30.2% [95% CI, 18.2%-42.2%]; P < .001 for both). The incidence of treatment-emergent adverse events was 25.2% with roflumilast vs 23.5% with vehicle in trial 1 and 25.9% with roflumilast vs 18.4% with vehicle in trial 2. The incidence of serious adverse events was 0.7% with roflumilast vs 0.7% with vehicle in trial 1 and 0% with roflumilast vs 0.7% with vehicle in trial 2.Conclusions and relevanceAmong patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety.Trial registrationClinicalTrials.gov Identifiers: NCT04211363, NCT04211389.

Dataset Information

Safety and Efficacy of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination Lotion in the Treatment of Moderate-to-severe Plaque Psoriasis: A Comparison with Halobetasol Propionate 0.05% Cream.

Publications

Safety and Efficacy of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination Lotion in the Treatment of Moderate-to-severe Plaque Psoriasis: A Comparison with Halobetasol Propionate 0.05% Cream.

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