A Nova Formulação de Calcipotriol/Dipropionato de Betametasona em Espuma Cutânea para o Tratamento da Psoríase
Resumo
A psoríase é uma doença inflamatória crónica da pele, imunomediada, potencialmente desfigurante e incapacitante, que afeta mundialmente mais de 100 milhões de indivíduos. A combinação fixa de calcipotriol e betametasona (0,005% Cal/ 0,064% BD) é o tratamento tópico recomendado. No entanto, os tratamentos tópicos estão associados a falta de eficácia e baixa adesão, nomeadamente devido às fracas propriedades cosméticas das formulações disponíveis. Para melhorar a aceitação e a adesão dos doentes, foi desenvolvida uma espuma cutânea de Cal/ BD para tratamento de adultos com psoríase. Os ensaios clínicos de fase II e III mostraram que a formulação fixa dos dois compostos é consistentemente mais eficaz e mais segura do que os ingredientes individuais, considerando o mesmo veículo. A espuma cutânea demonstrou maior eficácia em estudos clínicos, sendo que uma análise conjunta dos principais estudos mostrou que isso não ocorre à custa do perfil de segurança. Além disso, a espuma cutânea Cal/ BD mostrou uma melhoria significativa da eficácia em comparação com pomadas, géis e loções. O perfil de eficácia e segurança melhorado desta nova formulação, maior tolerabilidade e resposta mais rápida, aliados a uma menor frequência de tratamento (1x por dia), oferece maior conveniência e melhor aceitação do que as respetivas monoterapias (2x por dia) podendo, eventualmente, melhorar a adesão ao tratamento, conduzindo a melhorias mais significativas na qualidade de vida dos doentes, representando uma opção terapêutica mais vantajosa para os doentes. São necessários mais estudos para explorar a possibilidade desta espuma cutânea permitir a gestão da doença a longo prazo.
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Referências
World Health Organization (WHO). Global reports on psoriasis. 1.Psoriasis – epidemiology. 2.Psoriasis – prevention and control. 3.Public Health. 4.Skin Diseases.
WHO Library Cataloguing-in-Publication Data, 2016. [access Jun 2017] Available from: http://www.who.int
Kin KC, Hill D, Feldman SR. Calcipotriene and betamethasone dipropionate for the topical treatment of plaque psoriasis. Expert Rev Clin Pharmacol. 2016;9:789-97.
Kim ES, Frampton JE. Calcipotriol/Betamethasone Dipropionate Foam: A Review in Plaque Psoriasis. Drugs. 2016;76:1485-92.
Boehncke WH, Schön MP. Psoriasis. Lancet. 2015;386:983-94.
Danielsen K, Olsen AO, Wilsgaard T, Furberg AS. Is the prevalence of psoriasis increasing? A 30–year follow-up of a population–based cohort. Br J Dermatol. 2013; 168:1303–10.
Gibbs S. Skin disease and socioeconomic conditions in rural Africa: Tanzania. Int J Dermatol. 1996;35:633–9.
Massa A, Alves R, Amado J, Matos E, Sanches M, Selores M, et al. Prevalence of cutaneous lesions in Freixo de Espada à Cinta. Acta Med Port. 2000;13:247-54.
Torres T, Puig L. Treatment goals for psoriasis: Should PASI 90 become the standard of care? Actas Dermosifiliogr. 2015;106:155-7.
American Academy of Dermatology. Psoriasis. 2016. [access Jun 2017] Available from: http://www.aad.org
Torres T, Sales R, Vasconcelos C, Selores M. Psoriasis and cardiovascular disease. Acta Med Port. 2013;26:601-7.
Menter A, Gottlieb A, Feldman SR et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008; 58: 826-50.
Segaert S, Shear NH, Chiricozzi A, Thaçi D, Carrascosa JM, Young H, Descamps V. Optimizing Anti-Inflammatory and Immunomodulatory Effects of Corticosteroid and Vitamin D Analogue Fixed-Dose Combination Therapy. Dermatol Ther. 2017 (in press).
Nast A, Gisondi P, Ormerod AD, Saiag P, Smith C, Spuls PI, et al.. European S3-Guidelines on the systemic treatment of psoriasis vulgaris-Update 2015-Short version-EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29:2277-94.
Torres T, Velho GC, Sanches M, Selores M. Psoriasis in the era of biologics. Acta Med Port. 2010;23:493-8.
Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60:643-59.
Patel NU, Felix K, Reimer D, Feldman SR. Calcipotriene/betamethasone dipropionate for the treatment of psoriasis vulgaris: an evidence-based review. Clin Cosmet Investig Dermatol. 2017; 10:385-91.
Girolomoni G, Calzavara Pinton P, Cristaudo A, Cicchetti A. Back to the future: a new topical approach for mild-to-moderate psoriasis. G Ital Dermatol Venereol. 2016 (in press)
Diamantino F, Ferreira A. Future perspectives in the treatment of psoriasis: news in biological therapies. Acta Med Port. 2011;24:997-1004.
Samarasekera E, Sawyer L, Parnham J, Smith CH; Guideline Development Group. Assessment and management of psoriasis: summary of NICE guidance. BMJ. 2012;345:e6712. Review.
Leo Pharma A/S. Leo Pharma receives scientific approval of Enstilar® for the treatment of psoriasis in EU. 2016. [access Jun 2017] Available from: http://www.prnewswire.com
Leonardi C, Bagel J, Yamauchi P, Pariser D, Xu Z, Olesen M, et al. Efficacy and safety of calcipotriene plus betamethasone dipropionate aerosol foam in patients with psoriasis vulgaris-a randomized phase III study (PSO-FAST). J Drugs Dermatol. 2015;14:1468–77.
Leo Pharma. Enstilar® (calcipotriene and betamethasone dipropionate) foam: US prescribing information. 2016. [access Jun 2017] Available from: http://www.fda.gov. Leo Pharma. Enstilar® (calcipotriol/betamethasone dipropionate) cutaneous foam: UK summary of product characteristics. 2016. [access Jun 2017] Available from: https://www.medicines.org.uk/emc.
Queirós CS, Duarte GS, Costa J, Vaz-Carneiro A. Analysis of the Cochrane Review: Topical Treatments for Scalp Psoriasis.. Acta Med Port. 2017;30:163-8.
Enstilar Foam [package insert]. Parsippany: LEO Pharma Inc; 2015.
INFARMED. Enstilar RCM. INFARMED Drug Information [access Nov 2017] Available from: app10.infarmed.pt/infomed/inicio.php
Lind M, Nielsen KT, Schefe LH, Nørremark K, Eriksson AH, Norsgaard H, et al.. Supersaturation of Calcipotriene and Betamethasone Dipropionate in a Novel Aerosol Foam Formulation for Topical Treatment of Psoriasis Provides Enhanced Bioavailability of the Active Ingredients. Dermatol Ther. 2016;6:413-25.
FDA Center for Drug Evaluation and research. Enstilar® (calcipotriene and betamethasone) foam. Summary Review. 2015. [access Nov 2017] Available from: www.accessdata.fda.gov
Basse LH, Olesen M, Lacour JP, Queille-Roussel C. Enhanced in vitro skin penetration and antipsoriatic effect of fixed combination calcipotriol plus betamethasone dipropionate in an innovative foam vehicle. J Invest Dermatol. 2014;134:S33.
Paul C, Bang B, Lebwohl M. Fixed combination calcipotriol plus betamethasone dipropionate aerosol foam in the treatment of psoriasis vulgaris: rationale for development and clinical profile. Expert Opin Pharmacother. 2017;18:115-21.
Queille-Roussel C, Bang B, Clonier F, Lacour JP. Enhanced vasoconstrictor potency of the fixed combination calcipotriol plus betamethasone dipropionate in an innovative aerosol foam formulation vs. other corticosteroid psoriasis treatments. J Eur Acad Dermatol Venereol. 2016 ;30:1951-6.
Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Efficacy of an innovative aerosol foam formulation of fixed combination calcipotriol plus betamethasone dipropionate in patients with psoriasis vulgaris. Clin Drug Investig. 2015;35:239-45.
Taraska V, Tuppal R, Olesen M, Bang Pedersen C, Papp K. A Novel Aerosol Foam Formulation of Calcipotriol and Betamethasone Has No Impact on HPA Axis and Calcium Homeostasis in Patients With Extensive Psoriasis Vulgaris. J Cutan Med Surg. 2016;20:44-51.
Koo J, Tyring S, Werschler WP, Bruce S, Olesen M, Villumsen J, Bagel J. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study. J Dermatolog Treat. 2016;27:120-7.
Lebwohl M, Tyring S, Bukhalo M, Alonso-Llamazares J, Olesen M, Lowson D, Yamauchi P. Fixed combination aerosol foam calcipotriene 0.005% (cal) plus betamethasone dipropionate 0.064% (bd) is more efficacious than cal or bd aerosol foam alone for psoriasis vulgaris: a randomized, double-blind, multicenter, three-arm, phase 2 study. J Clin Aesthet Dermatol. 2016;9:34-41.
Queille-Roussel C, Rosen M, Clonier F, Nørremark K, Lacour JP. Efficacy and safety of calcipotriol plus betamethasone dipropionate aerosol foam compared with betamethasone 17-valerate-medicated plaster for the treatment of psoriasis. Clin Drug Investig. 2017 ;37:355-361.
Globe D, Bayliss MS, Harrison DJ. The impact of itch symptoms in psoriasis: results from physician interviews and patient focus groups. Health Qual Life Outcomes. 2009;7:62.
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) - a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19:210-6.
Paul C, Stein Gold L, Cambazard F, Kalb RE, Lowson D, Bang B, et al. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study. J Eur Acad Dermatol Venereol.
;31:119-26..
Paul C, Leonardi C, Menter A, Reich K, Gold LS, Warren RB, et al. Calcipotriol plus betamethasone dipropionate aerosol foam in patients with moderate-to-severe psoriasis:
sub-group analysis of the PSO-ABLE Study. Am J Clin Dermatol. 2017 Jun;18(3):405-411. Erratum in: Am J Clin Dermatol. 2017 (in press).
Norsgaard H, Kurdykowski S, Descargues P, Gonzalez T, Marstrand T, Dünstl G, et al. Calcipotriol counteracts betamethasone-induced decrease in extracellular matrix components related to skin atrophy. Arch Dermatol Res. 2014;306:719-29.
Jensen JD, Fujita M, Dellavalle RP. Validation of psoriasis clinical severity and outcome measures: searching for a gold standard. Arch Dermatol. 2011;147:95-8.
Fleming C, Ganslandt C, Guenther L, Johannesson A, Buckley C, Simon JC, et al. Calcipotriol plus betamethasone dipropionate gel compared with its active components in the same vehicle and the vehicle alone in the treatment of psoriasis vulgaris: a randomised, parallel group, double-blind, exploratory study. Eur J Dermatol. 2010 ;20:465-71.
Kragballe K, van de Kerkhof P. Pooled safety analysis of calcipotriol plus betamethasone dipropionate gel for the treatment of psoriasis on the body and scalp. J Eur Acad
Dermatol Venereol. 2014;28 Suppl 2:10-21.
Queille-Roussel C, Liljedahl M, Clonier F, Lacour JP. Phase 1 evaluation of the dermal safety of the fixed combination calcipotriene plus betamethasone dipropionate aerosol foam and foam vehicle. J Am Acad Dermatol 2015;72 (Suppl 1):AB211 (P844).
Leonardi C, Bagel J, Yamauchi P, Pariser D, Xu Z, Moller A, et al. The aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate improves the health-related quality of life in patients with psoriasis vulgaris: results from the randomized PSO-FAST Study. J Drugs Dermatol. 2016;15:981-7.
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