The MARCOPOLO Study of Ustekinumab Utilization and Efficacy in a Real-World Setting: Treatment of Patients with Plaque Psoriasis in Asia-Pacific Countries
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Background: Ustekinumab is a fully human monoclonal antibody approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults. However, factors including efficacy, tolerability, ease of use, and cost burden may affect ustekinumab utilization. Noncompliance may, in turn, affect treatment response. Objective: To evaluate ustekinumab utilization in the real-world setting in Asia-Pacific countries. Methods: In this phase 4 observational study conducted in Indonesia, Malaysia, Singapore, Korea, and Taiwan, adults with plaque psoriasis receiving ustekinumab were followed for up to 52 weeks. Study endpoints were the proportion of all patients using ustekinumab according to label-recommended intervals and the proportion of Korean patients who achieved a psoriasis area severity index 75 response at week 16. Safety was assessed by monitoring adverse events. Results: Overall, 169 patients received ustekinumab (Korea, n=102; other countries, n=67). Just over half (56.2%) of patients used ustekinumab with the label-recommended interval from baseline to week 40; the proportion was higher in Korea (73.5%) than in other countries (29.9%), probably because ustekinumab was provided without charge for Korean patients up to week 40. Noncompliance increased after week 40 in Korea and from week 28 in other Asia-Pacific countries, with cost cited as the most common reason. At week 16, 56.9% of Korean patients achieved a Psoriasis Area Severity Index 75 response. Safety results were in line with those seen in previous studies. Conclusion: More than half of all patients in Asia-Pacific countries used ustekinumab as per the label-recommended dose interval, but reimbursement variations between countries may have confounded overall results.
Abstract
Background: Ustekinumab is a fully human monoclonal antibody approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults. However, factors including efficacy, tolerability, ease of use, and cost burden may affect ustekinumab utilization. Noncompliance may, in turn, affect treatment response. Objective: To evaluate ustekinumab utilization in the real-world setting in Asia-Pacific countries. Methods: In this phase 4 observational study conducted in Indonesia, Malaysia, Singapore, Korea, and Taiwan, adults with plaque psoriasis receiving ustekinumab were followed for up to 52 weeks. Study endpoints were the proportion of all patients using ustekinumab according to label-recommended intervals and the proportion of Korean patients who achieved a psoriasis area severity index 75 response at week 16. Safety was assessed by monitoring adverse events. Results: Overall, 169 patients received ustekinumab (Korea, n=102; other countries, n=67). Just over half (56.2%) of patients used ustekinumab with the label-recommended interval from baseline to week 40; the proportion was higher in Korea (73.5%) than in other countries (29.9%), probably because ustekinumab was provided without charge for Korean patients up to week 40. Noncompliance increased after week 40 in Korea and from week 28 in other Asia-Pacific countries, with cost cited as the most common reason. At week 16, 56.9% of Korean patients achieved a Psoriasis Area Severity Index 75 response. Safety results were in line with those seen in previous studies. Conclusion: More than half of all patients in Asia-Pacific countries used ustekinumab as per the label-recommended dose interval, but reimbursement variations between countries may have confounded overall results.
참고문헌 (27)
- Hay RJ., "The global burden of skin disease in 2010 : an analysis of the prevalence and impact of skin conditions", J Invest Dermatol, 134, pp.1527~1534 (2014)
- Parisi R., "Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence", J Invest Dermatol, 133, pp.377~385 (2013)
- Cingoz O, "Ustekinumab", MAbs, 1, pp.216~221 (2009)
- 이영욱, "Impact of Psoriasis on Quality of Life: Relationship between Clinical Response to Therapy and Change in Health-related Quality of Life", Annals of Dermatology, 22(4), pp.389~396 (2010), 대한피부과학회
- Tsai TF., "Epidemiology and comorbidities of psoriasis patients in a national database in Taiwan", J Dermatol Sci, 63, pp.40~46 (2011)
- Na SJ., "Clinical study on psoriasis patients for past 30 years(1982-2012)in Seoul National University Hospital Psoriasis Clinic", J Dermatol, 40, pp.731~735 (2013)
- Chandran V., "Geoepidemiology and environmental factors of psoriasis and psoriatic arthritis", J Autoimmun, 34, pp.J314~J321 (2010)
- 이혜민, "Prevalence of Vitiligo and Associated Comorbidities in Korea", Yonsei Medical Journal, 56(3), pp.719~725 (2015), 연세대학교의과대학[DOI]
- Raychaudhuri SP., "The prevalence of psoriasis in the world", J Eur Acad Dermatol Venereol, 15, pp.16~17 (2001)
- O'Neill JL., "Ustekinumab in the therapy of chronic plaque psoriasis", Biologics, 3, pp.159~168 (2009)
- Nestle FO., "The IL-12 family member p40 chain as a master switch and novel therapeutic target in psoriasis", J Invest Dermatol, 123, pp.xiv~xv (2004)
- Lew W., "Psoriasis genomics : analysis of proinflammatory(type 1)gene expression in large plaque(Western)and small plaque(Asian)psoriasis vulgaris", Br J Dermatol, 150, pp.668~676 (2004)
- Cargill M., "A large-scale genetic association study confirms IL12B and leads to the identification of IL23R as psoriasis-risk genes", Am J Hum Genet, 80, pp.273~290 (2007)
- Leonardi CL., "Efficacy and safety of ustekinumab, a human interleukin-12", 23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1), 2008, pp.371, 1665~1674
- Papp KA., "Efficacy and safety of ustekinumab, a human interleukin-12", 23 monoclonal antibody, in patients with psoriasis : 52-week results from a randomised, double-blind, placebo-controlled trial(PHOENIX 2), 2008, pp.371, 1675~1684
- Zhu X., "Efficacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-type psoriasis : results from a phase 3 clinical trial(LOTUS)", J Drugs Dermatol, 12, pp.166~174 (2013)
- Tsai TF., "Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis : a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients(PEARL)", J Dermatol Sci, 63, pp.154~163 (2011)
- Igarashi A., "Efficacy and safety of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis : long-term results from a phase 2", 3 clinical trial, 2012, pp.39, 242~252
- Reich K., "An update on the long-term safety experience of ustekinumab : results from the psoriasis clinical development program with up to four years of follow-up", J Drugs Dermatol, 11, pp.300~312 (2012)
- Kimball AB., "Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study", J Eur Acad Dermatol Venereol, 27, pp.1535~1545 (2013)
- Callis Duffin K., "Patient satisfaction with treatments for moderate-to-severe plaque psoriasis in clinical practice", Br J Dermatol, 170, pp.672~680 (2014)
- Yeung H., "Patient-reported reasons for the discontinuation of commonly used treatments for moderate to severe psoriasis", J Am Acad Dermatol, 68, pp.64~72 (2013)
- "Highlights of prescribing information" (2012)[URL]
- "Summary of product characteristics" (2014)[URL]
- 윤상웅, "Reduction of Inter-Rater and Intra-Rater Variability in Psoriasis Area and Severity Index Assessment by Photographic Training", Annals of Dermatology, 27(5), pp.557~562 (2015), 대한피부과학회
- 윤상웅, "Comparison of Treatment Goals for Moderate-to-Severe Psoriasis between Korean Dermatologists and the European Consensus Report", Annals of Dermatology, 27(2), pp.184~189 (2015), 대한피부과학회
- Chiu HY., "The safety profile of ustekinumab in the treatment of patients with psoriasis and concurrent hepatitis B or C", Br J Dermatol, 169, pp.1295~1303 (2013)