Impact of Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% in the Management of Plaque Psoriasis in Adults.
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ABSTRACT:
SUBMITTER: Reddy V
PROVIDER: S-EPMC7295208 | biostudies-literature | 2020
REPOSITORIES: biostudies-literature
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Impact of Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% in the Management of Plaque Psoriasis in Adults.
Reddy Vidhatha V Myers Bridget B Yang Eric J EJ Bhutani Tina T
Clinical, cosmetic and investigational dermatology 20200611
Halobetasol propionate and tazarotene lotion 0.01%/0.045% (HP/TAZ) is a topical medication approved for the treatment of plaque psoriasis in adults. As a treatment modality, HP/TAZ has a combinatory therapeutic effect because it contains both a corticosteroid (HP) and a retinoid (TAZ) component. Here, we review the important clinical efficacy and safety data derived from pivotal clinical trials for HP/TAZ in the treatment of plaque psoriasis. We also discuss the mechanism of action, dosage guide ...[more]
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Project description: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.
| S-EPMC6303116 | biostudies-literature
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.
| S-EPMC9588120 | biostudies-literature
Project description:During the 28th Congress of the European Academy of Dermatology and Venereology (EADV) held in Madrid in October 2019, an industry hub was dedicated to the long-term management of psoriasis. Psoriasis is a systemic inflammatory disease primarily involving the skin that affects up to 4% of the European population, the majority of whom present with chronic plaque psoriasis. Topical therapies are well established in the first-line treatment of psoriatic plaque flares. Nevertheless, as psoriasis is a chronic disease, long-term control should be considered. The aim of the session was to provide expert opinion on the benefit of long-term maintenance therapy in chronic plaque psoriasis and introduce the concept of pro-active management to decrease the number of relapses and improve patient quality of life. The current guidelines and recommendations were reviewed, as well as the available data on published clinical trials. There is still an important role for topical therapy in psoriasis and current recommendations suggest a maintenance regimen for psoriasis. Adherence optimization and proactive management of relapse can be key factors for obtaining clinical outcomes in topical long-term therapy. Calcipotriol/betamethasone dipropionate foam is the only topical formulation with long-term data as a twice-weekly proactive treatment approach for up to 52 weeks for chronic plaque psoriasis.
| S-EPMC7397561 | biostudies-literature
Project description:Psoriasis affects 1-3% of the population, in some people causing changes to the nails and joints in addition to skin lesions. We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of systemic drug treatments, topical drug treatments, and non-drug treatments (other than ultraviolet light) for chronic plaque psoriasis? What are the effects of ultraviolet light treatments for chronic plaque psoriasis? What are the effects of combined treatment with drugs plus ultraviolet light on chronic plaque psoriasis? What are the effects of combined systemic plus topical drug treatments for chronic plaque psoriasis? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2007 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 122 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, adding calcipotriol (topical) to psoralen plus ultraviolet light A or ultraviolet light B, adding oral retinoids to psoralen plus ultraviolet A (PUVA), alefacept, balneotherapy, ciclosporin, dithranol, T cell-targeted therapies, cytokine blocking agents, emollients (alone or plus ultraviolet light B), etanercept, fish oil supplementation, fumaric acid derivatives, Goeckerman treatment, heliotherapy, infliximab, Ingram regimen, keratolytics (salicylic acid, urea), leflunomide, methotrexate, oral pimecrolimus, phototherapy plus balneotherapy, psoralen plus ultraviolet A, psychotherapy, oral retinoids (alone or with ultraviolet light B), systemic drug treatments plus topical vitamin D derivatives, tars, tazarotene, topical corticosteroids (alone or plus oral retinoids), topical Vitamin D derivatives, ultraviolet light A, and ultraviolet light B.
| S-EPMC2907770 | biostudies-literature
Project description:CLINICAL TRIALS ID: NCT02938494 BACKGROUND: In a Phase II study, tazarotene 0.045% lotion was statistically superior to vehicle and comparable to tazarotene 0.1% cream in reducing acne lesions, with fewer treatment-related adverse events (TEAEs) than the cream. OBJECTIVE: We analyzed data from the aforementioned study post-hoc to evaluate the effects of sex on treatment outcomes. METHODS: Participants aged 12 years or older with moderate-to-severe acne were randomized to tazarotene (0.045% lotion or 0.1% cream) or vehicle (lotion or cream) for 12 weeks of double-blind treatment. Outcomes analyzed in male and female subgroups included changes from baseline in inflammatory/noninflammatory lesions and TEAEs. RESULTS: In the intent-to-treat population (94 males and 116 females), reductions in lesion count were greater with tazarotene (lotion or cream) than with vehicle. In participants receiving tazarotene 0.045% lotion, the least-squares mean percent changes from baseline to Week 12 were greater in females than males, but the differences were not statistically significant (inflammatory [-70.3% vs. -56.2%]; noninflammatory [-60.0% vs. -53.2%]). In both females and males, the TEAE incidence was lower with tazarotene 0.045% lotion than 0.1% cream. CONCLUSION: Tazarotene 0.045% lotion substantially reduced acne lesions in both female and male participants. This newest tazarotene formulation might benefit patients who cannot tolerate older formulations or other topical retinoids. Given the relatively small size of this study, however, the results of this post-hoc analysis are intended to be exploratory in nature.
| S-EPMC8142831 | biostudies-literature
Project description:IntroductionPsoriasis is an immune-mediated, chronic, inflammatory disease, which has a substantial humanistic and economic burden. This study aimed to assess the impact of this disease on health-related quality of life (HRQoL), work productivity, and direct and indirect costs from a societal perspective among Brazilian patients.MethodsThis is a cross-sectional, observational, multicenter study, enrolling patients with moderate to severe plaque psoriasis according to physician evaluation. Data collection was performed from December 2015 to November 2016 through face-to-face interviews using a structured questionnaire and five standardized patient-reported outcomes instruments. Direct costs were estimated by multiplying the amount of resources used (12-month recall period) by the corresponding unit cost. Indirect costs were grouped in two time horizons: annual costs (income reduction and absenteeism) and lifetime costs (demission and early retirement).ResultsA total of 188 patients with moderate to severe plaque psoriasis were included, with mean age of 48.0 (SD 13.1). "Anxiety and depression" and "pain and discomfort" were the most impaired dimensions, according to the EuroQol Five-Dimension-Three-Level (EQ-5D-3L). The highest effect was found for "symptoms and feelings" [mean (SD) 2.4 (1.7)] Dermatology Life Quality Index (DLQI) subscale. Psoriatic arthritis (PsA) presence and biologic-naïve status were associated with worse HRQoL. Presenteeism was more frequent than absenteeism, according to the Work Productivity and Activity Impairment questionnaire-General Health (WPAI-GH) [17.4% vs. 6.3%], while physical demands and time management were the most affected Work Limitations Questionnaire (WLQ) subscales [means (SD) 23.5 (28.5) and 17.7 (24.9), respectively]. The estimated annual cost per patient was USD 4034. Direct medical costs accounted for 87.7% of this estimate, direct non-medical costs for 2.4%, and indirect costs for 9.9%.ConclusionsResults evidenced that moderate to severe plaque psoriasis imposes substantial costs to society. Our data showed that this disease negatively affects both work productivity and HRQoL of Brazilian patients. Subgroups with PsA and biologic-naïve patients presented lower HRQoL, showing the impact of this comorbidity and the relevance of biologics in psoriasis treatment.FundingNovartis Biociências S.A.
| S-EPMC6822973 | biostudies-literature
Project description:Plaque psoriasis is a common inflammatory condition of the skin characterized by red, flaking lesions. Current therapies for plaque psoriasis target many facets of the autoimmune response, but there is an incomplete understanding of how oxidative damage produced by enzymes such as myeloperoxidase contributes to skin pathology. In this study, we used the Aldara (Imiquimod) cream model of plaque psoriasis in mice to assess myeloperoxidase inhibition for treating psoriatic skin lesions. To assess skin inflammation severity, an innovative mouse psoriasis scoring system was developed. We found that myeloperoxidase inhibition ameliorated psoriasis severity when administered either systemically or topically. The findings of this study support the role of oxidative damage in plaque psoriasis pathology and present potential new therapeutic avenues for further exploration.
| S-EPMC8472607 | biostudies-literature
Project description:INTRODUCTION:Psoriasis is a chronic, inflammatory, T-cell-mediated and hyperproliferative skin disease characterized by erythematous, squamous, sharply circumscribed and infiltrated plaques. The metabolisms of the collagen proteins undergo considerable changes due to the acceleration of their turnovers as a result of increased prolidase activity in psoriasis patients. AIM:To determine the level of prolidase activity in psoriasis patients and evaluate its relationship with the oxidative system. MATERIAL AND METHODS:The serum prolidase enzyme activity, total antioxidant levels and total oxidant levels of 40 psoriasis patients and a control group including 47 healthy individuals were analyzed by using their serum samples, and their oxidative stress indices were calculated. RESULTS:The prolidase levels (p < 0.01), total oxidant levels (p < 0.01) and oxidative stress index levels (p < 0.001) of the patient group were higher than the corresponding parameters in the control group. The total antioxidant level was low (p < 0.01). Although a positive correlation was found between the prolidase and total antioxidant levels and the total oxidant level, no correlation was found between prolidase and the oxidative stress index. CONCLUSIONS:It has been determined that the activity of the prolidase enzyme increases due to the increased collage turnover in psoriasis patients. Increased serum oxidant levels and oxidative stress indices values may play a role in the pathogenesis of psoriasis.
| S-EPMC4436238 | biostudies-literature
Project description:Generalized pustular psoriasis (GPP) is a rare, debilitating, and often life-threatening inflammatory disease characterized by episodic infiltration of neutrophils into the skin, pustule development, and systemic inflammation, which can manifest in the presence or absence of chronic plaque psoriasis (PV). Current treatments are unsatisfactory thus a better understanding the pathogenesis of GPP is warranted. To assess the pathophysiological differences between GPP and PV we performed a gene expression study on formalin-fixed paraffin-embedded biopsies of GPP (n=30) and PV (n=12) lesions and healthy control (n=20) skin. Compared with healthy skin, GPP lesions yielded 365 and PV 898 differentially expressed genes respectively, with 190 upregulated in both diseases. We detected higher expression of IL-1 and IL-36 cytokines in GPP lesions compared with PV, and this occurred proximal to neutrophils. We show both activated neutrophils and isolated neutrophil proteases can activate IL-36. Diverging from the Th1/Th17 pathophysiology of PV, significantly fewer IL23A, IL17A, IFNG, CXCL9, CXCL10 and MX1 transcripts were detected in GPP lesions. Our data indicate a level of sustained activation of IL-1 and IL-36 in GPP, inducing neutrophil chemokine expression, infiltration and pustule formation, suggesting that the IL-1 and IL-36 inflammatory axes are the main drivers of disease pathology in GPP.
2017-01-27 | GSE79704 | GEO
Project description:BACKGROUND:Plaque psoriasis is a non-contagious skin disease in which characteristic red and flaky lesions result from a dysregulation involving both innate and adaptive immune mechanisms. Several cytokines have been implicated in these processes and lately interleukin (IL)-36 family members have become more recognised among them. Thus far, genetic studies have only investigated IL36RN gene of this family in relation to pustular psoriasis. Since IL36G has previously demonstrated markedly increased levels in plaque psoriasis patients and is linked to IL-23/IL-17 axis critical in psoriasis pathology, it was chosen to be the focus of current report. METHODS:Eleven SNPs from IL36G region were genotyped in 728 plaque psoriasis patients and 320 healthy control individuals. Allele and haplotype frequencies between patients and controls were assessed by respective association tests. For more specific analyses, the patients were assigned into subgroups according to sex, age of disease onset, occurrence of psoriasis among relatives, seasonal aggravation, arthritis symptoms, body surface area (BSA) scores, and Psoriasis Area and Severity Index (PASI) scores. RESULTS:The most significant results were obtained with SNPs rs28947206, rs28947207 and rs28947211 that were associated in entire plaque psoriasis analysis (multiple testing adjusted p value (padj)?=?0.0054, padj =?0.0017 and padj =?0.0001) and also several subgroups. The first two of those SNPs were included in the same haplotype block with rs28947205 and rs12328178, and two of the respective haplotypes, CAGC and TGTT, provided similarly significant associations (padj =?0.0462 and padj =?0.0047). CONCLUSIONS:The associated SNPs of this study or those in linkage disequilibrium with them could potentially affect the functionality of IL-36? cytokine, which in turn may impact plaque psoriasis pathology. For instance, these variants could influence IL-36? expression or 3D structure, thereby altering its ability to induce chemokine production in keratinocytes and various immune cells. The precise mechanisms of these actions are currently unknown and out of the scope of this study. To conclude, the present genetic association results confirm the proposed role of IL-36? in plaque psoriasis development, with corresponding causal effects to be determined in forthcoming research.
| S-EPMC6330488 | biostudies-literature