Efficacy, quality of life, and treatment satisfaction: an indirect comparison of calcipotriol/betamethasone dipropionate cream versus foam for treatment of psoriasis

References

• Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet. 2007;370(9583):263–271.
   PubMed Web of Science ®Google Scholar
• Parisi R, Iskandar IYK, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020;369:m1590.
   PubMed Web of Science ®Google Scholar
• Damiani G, Bragazzi NL, Karimkhani Aksut C, et al. The global, regional, and national burden of psoriasis: results and insights from the global burden of disease 2019 study. Front Med. 2021;8:743180.
   PubMed Web of Science ®Google Scholar
• Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3 Pt 1):401–407.
   PubMed Web of Science ®Google Scholar
• Caputo V, Strafella C, Cosio T, et al. Pharmacogenomics: an update on biologics and small-molecule drugs in the treatment of psoriasis. Genes. 2021;12(9):1398.
   PubMed Web of Science ®Google Scholar
• Campione E, Cosio T, Di Prete M, et al. Experimental pharmacological management of psoriasis. J Exp Pharmacol. 2021;13:725–737.
   PubMedGoogle Scholar
• National Institute for Health and Care Excellence (NICE). Psoriasis: assessment and management. Clinical Guideline; 2017.
   Google Scholar
• Menter A, Gelfand JM, Connor C, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445–1486.
   PubMed Web of Science ®Google Scholar
• Menter A, Korman NJ, Elmets CA, 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(4):643–659.
   PubMed Web of Science ®Google Scholar
• Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029–1072.
   PubMed Web of Science ®Google Scholar
• Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):432–470.
   PubMed Web of Science ®Google Scholar
• Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137–174.
   PubMed Web of Science ®Google Scholar
• Nast A, Boehncke WH, Mrowietz U, et al. German S3-guidelines on the treatment of psoriasis vulgaris (short version). Arch Dermatol Res. 2012;304(2):87–113.
   PubMed Web of Science ®Google Scholar
• Stein Gold L, Green LJ, Dhawan S, et al. A phase 3, randomized trial demonstrating the improved efficacy and patient acceptability of fixed dose calcipotriene and betamethasone dipropionate cream. J Drugs Dermatol. 2021;20(4):420–425.
   PubMed Web of Science ®Google Scholar
• Carroll CL, Feldman SR, Camacho FT, et al. Better medication adherence results in greater improvement in severity of psoriasis. Br J Dermatol. 2004;151(4):895–897.
   PubMed Web of Science ®Google Scholar
• Bewley A, Page B. Maximizing patient adherence for optimal outcomes in psoriasis. J Eur Acad Dermatol Venereol. 2011;25(Suppl 4):9–14.
   PubMed Web of Science ®Google Scholar
• Fouéré S, Adjadj L, Pawin H. How patients experience psoriasis: results from a European survey. J Eur Acad Dermatol Venereol. 2005;19 Suppl 3:2–6.
   PubMed Web of Science ®Google Scholar
• NCT03802344 – a randomised, multicentre, investigator-blind, parallel-group trial to evaluate the efficacy and safety of MC2-01 cream compared to vehicle and active comparator in subjects with mild-to-moderate psoriasis vulgaris [Internet]. [cited 2021 Jul 6]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03802344?term=NCT03802344&draw=2&rank=1
   Google Scholar
• NCT03308799 – a randomised, multicentre, investigator-blind, parallel-group trial to evaluate the efficacy and safety of MC2-01 cream compared to vehicle and active comparator in subjects with mild-to-moderate psoriasis vulgaris [Internet]. [cited 2021 Jul 6]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03308799?term=NCT03308799&draw=2&rank=1
   Google Scholar
• Paul C, Stein Gold L, Cambazard F, 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. 2017;31(1):119–126.
   PubMed Web of Science ®Google Scholar
• Paul C, Leonardi C, Menter A, 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;18(3):405–411.
   PubMed Web of Science ®Google Scholar
• Griffiths CE, Stein Gold L, Cambazard F, et al. Greater improvement in quality of life outcomes in patients using fixed-combination calcipotriol plus betamethasone dipropionate aerosol foam versus gel: results from the PSO-ABLE study. Eur J Dermatol. 2018;28(3):356–363.
   PubMed Web of Science ®Google Scholar
• Hong C-H, Papp KA, Lophaven KW, et al. Patients with psoriasis have different preferences for topical therapy, highlighting the importance of individualized treatment approaches: randomized phase IIIb PSO-INSIGHTFUL study. J Eur Acad Dermatol Venereol. 2017;31(11):1876–1883.
   PubMed Web of Science ®Google Scholar
• Campanati A, Atzori L, Potenza C, et al. Patient satisfaction with calcipotriol/betamethasone dipropionate cutaneous foam for the treatment of plaque psoriasis: the LION real‐life multicenter prospective observational cohort study. Dermatol Ther. 2021;34(5):34.
   Web of Science ®Google Scholar
• Lebioda A, Gasche D, Dippel F-W, et al. Relevance of indirect comparisons in the German early benefit assessment and in comparison to HTA processes in England, France and Scotland. Health Econ Rev. 2014;4(1):31.
   PubMedGoogle Scholar
• Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. General Methods [Internet]; 2020 [cited 2021 Jul 8]. Available from: https://www.iqwig.de/methoden/general-methods_version-6-0.pdf?rev=194070
   Google Scholar
• Haute Autorité de Santé. Indirect comparisons – methods and validity [Internet]. Saint-Denis La Plaine CEDEX; 2009. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2011-02/summary_report__indirect_comparisons_methods_and_validity_january_2011_2.pdf
   Google Scholar
• National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal 2013. Process and methods [Internet]; 2013 [cited 2021 Jul 8]. Available from: https://www.nice.org.uk/process/pmg9/resources/guide-to-the-methods-of-technology-appraisal-2013-pdf-2007975843781
   Google Scholar
• European Network for Health Technology Assessments (EUnetHTA). Guideline Comparators & comparisons: direct and indirect comparisons [Internet]; 2015 [cited 2021 Jul 8]. Available from: https://www.eunethta.eu/wp-content/uploads/2018/01/Comparators-Comparisons-Direct-and-indirect-comparisons_Amended-JA1-Guideline_Final-Nov-2015.pdf
   Google Scholar
• Pinter A, Green L, Selmer J, et al. A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis. J Eur Acad Dermatol Venereol. 2022;36(2):228–236.
   PubMed Web of Science ®Google Scholar
• Bucher HC, Guyatt GH, Griffith LE, et al. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol. 1997;50(6):683–691.
   PubMed Web of Science ®Google Scholar
• Phillippo D, Ades T, Dias S, et al. NICE DSU Technical Support Document 18: methods for population-adjusted indirect comparisons in submissions to NICE; 2016. [cited 2021 Jul 8]. Available from: https://research-information.bris.ac.uk/en/publications/nice-dsu-technical-support-document-18-methods-for-population-adj
   Google Scholar
• Danish Medicines Council. The Danish Medicines Council methods guide for assessing new pharmaceuticals [Internet]; 2021 [cited 2021 Jul 8]. Available from: https://medicinraadet.dk/media/wq0dxny2/the_danish_medicines_council_methods_guide_for_assessing_new_pharmaceuticals_version_1-2_adlegacy.pdf
   Google Scholar
• Statens Legemiddelverk. Guidelines for the submission of documentation for single technology assessment (STA) of pharmaceuticals [Internet]; 2020 [cited 2021 Jul 8]. Available from: https://legemiddelverket.no/Documents/English/Public%20funding%20and%20pricing/Documentation%20for%20STA/Guidelines%2020.05.2020.pdf
   Google Scholar
• U.S. Food and Drug Administration. Full prescribing information for Wynzora® (calcipotriene and betamethasone dipropionate cream); 2020.
   Google Scholar
• U.S. Food and Drug Administration. Full prescribing information for Enstilar® (calcipotriene and betamethasone dipropionate foam); 2006.
   Google Scholar
• U.S. Food and Drug Administration. Full prescribing information for Taclonex® (calcipotriene and betamethasone dipropionate topical suspension); 2006.
   Google Scholar
• NCT02310646 – a clinical trial gathering insight of patient reported factors that influence preference following once daily topical treatment with LEO 90100 aerosol foam and Daivobet® gel in subjects with psoriasis vulgaris [Internet] [cited 2021 Jul 8]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT02310646?term=NCT02310646&draw=2&rank=1
   Google Scholar