Analysis of Patients with Moderate to Severe Psoriasis before Starting Biologic Therapy in the Czech Republic – Data from BIOREP Registry 2005 – 2016

Česká verzia

Authors: M. Kojanová ¹; J. Fialová ¹; P. Cetkovská ²; S. Gkalpakiotis ³; J. Jirčíková ⁴; T. Doležal ⁴; P. Arenberger ³; Skupina Biorep
Authors place of work: Dermatovenerologická klinika VFN a 1. LF UK, Praha přednosta prof. MUDr. Jiří Štork, CSc. ¹; Dermatovenerologická klinika FN a LF UK, Plzeň přednosta prof. MUDr. Karel Pizinger, CSc. ²; Dermatovenerologická klinika 3. LF UK a FNKV, Praha přednosta prof. MUDr. Petr Arenberger, DrSc., MBA ³; Value Outcomes, Praha ⁴
Published in the journal: Čes-slov Derm, 91, 2016, No. 5, p. 223-232
Category: Pharmacologyand Therapy, Clinical Trials

Summary

Background and objective:
Evaluation of patients with severe psoriasis treated with biologics in the Czech Republic and included in the register of biological therapy BIOREP.

Methods:
We performed a retrospective evaluation of patients with severe psoriasis enrolled in the registry BIOREP from May 2005 to May 2016. The number of patients on biological therapy was evaluated and analysed according to the age and gender in this period, the incidence of associated disorders was assessed and the characteristics were compared with published data in literature.

Results:
Baseline data were collected from 17 dermatology biological therapy centres. As of May 2016, 1525 patients were registered in BIOREP registry with a predominance of males (63.5%). The average patient age was 50.9 years. The mean baseline Psoriasis Area and Severity Index was 19.5 and the Dermatology Life Quality Index was 17.0. A total of 40.2% of patients reported a history of psoriatic arthritis. In our cohort a high proportion of patients (59.2%) with cardiovascular risk factors [hypertension (36.9%), hyperlipidemia (28.6%), diabetes mellitus (12.4%), coronary heart disease (4.9%), and obesity (32.4%)] were observed. 72% of patients were overweight or obese. Only 32.1% of patients had no concomitant disease, 31.0% of patients had one, 18.4% two, 12.8% three, and 5.7% of patients four or more comorbidities. The majority of patients had been previously treated with phototherapy (86.0%), acitretin (75.5%), methotrexate (69.3%) or ciclosporin (54.0%).

Conclusion:
BIOREP is the first registry of patients with psoriasis treated with biologics in Central and Eastern Europe. Our results found a similar or even higher prevalence of comorbidities, long disease duration before biological treatment introduction and high impact on the quality of life among patients included in European registries.

Key words:
psoriasis – biological therapy – registries

Zdroje

1. ARMESTO, S., COTO-SEGURA, P., OSUNA, C. G. et al. Psoriasis and hypertension: a case-control study. J. Eur. Acad. Dermatol. Venereol., 2012, 26, p. 785–788.

2. ARMESTO, S., SANTOS-JUANES, J., GALACHE-OSUNA, C. et al. Psoriasis and type 2 diabetes risk among psoriatic patients in a Spanish population, Australas J. Dermatol., 2012, 53, p. 128–130.

3. ARMSTRONG, A. W., HARSKAMP, C. T., ARMSTRONG, E. J. The association between psoriasis and obesity: a systematic review and meta-analysis of observational studies. Nutr. Diabetes, 2012, 2, e54.

4. ARMSTRONG, A. W., LIN, S. W., CHAMBERS, C. J. et al. Psoriasis and the risk of diabetes and hypertension: a prospective study of US female nurses. Arch. Dermatol., 2009, 145, p. 379–338.

5. ARMSTRONG, A. W., ROBERTSON, A. D., WU, J. et al. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol., 2013, 149, p. 1180–1185.

6. AUGUSTIN, M., SPEHR, C., RADTKE, M. A. et al. German psoriasis registry PsoBest: objectives, methodology and baseline data. J. Dtsch. Dermatol. Ges., 2014, 12, p. 48–57.

7. BOEHNCKE, W. H., BOEHNCKE, S., TOBIN, A. M. et al. The ‘psoriatic march’: a concept of how severe psoriasis may drive cardiovascular comorbidity. Exp. Dermatol., 2011, 20, p. 303–307.

8. CARRASCOSA, J. M., VILAVELLA, M., GARCIA-DOVAL, I. et al. Body mass index in patients with moderate-to-severe psoriasis in Spain and its impact as an independent risk factor for therapy withdrawal: results of the Biobadaderm Registry. J. Eur. Acad. Dermatol. Venereol., 2014, 28, p. 907–914.

9. CARRETERO, G., FERRANDIZ, C., DAUDEN, E. et al. Risk of adverse events in psoriasis patients receiving classic systemic drugs and biologics in a 5-year observational study of clinical practice: 2008–2013 results of the Biobadaderm registry. J. Eur. Acad. Dermatol. Venereol., 2015, 29, p. 156–163.

10. CETKOVSKÁ, P., KOJANOVÁ, M. Česká doporučení k biologické léčbě závažné chronické ložiskové psoriázy. Čes-slov. Derm., 2012, 87, p. 17–37.

11. DAVIDOVICI, B. B., SATTAR, N., PRINZ, J. C. et al. Psoriasis and systemic inflammatory diseases: potential mechanistic links between skin disease and co-morbid conditions. J. Invest. Dermatol., 2010, 130, p. 1785–1796.

12. DING, X., WANG, T., SHEN, Y. et al. Prevalence of psoriasis in China: a population-based study in six cities. Eur. J. Dermatol., 2012, 22, p. 663–667.

13. EDER, L., HADDAD, A., ROSEN, C. F. et al. The incidence and risk factors for psoriatic arthritis in patients with psoriasis – a prospective cohort study. Arthritis Rheumatol., 2016, 68, p. 915–923.

14. GARCIA-DOVAL, I., CARRETERO, G., VANACLOCHA, F. et al. Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients ineligible vs eligible for randomized controlled trials. Arch. Dermatol., 2012, 148, p. 463–470.

15. GERDES, S., OSADTSCHY, S., BUHLES, N. et al. Cardiovascular biomarkers in patients with psoriasis. Exp. Dermatol., 2014, 23, p. 322–325.

16. GNIADECKI, R., BANG, B., BRYLD, L. E. et al. Comparison of long-term drug survival and safety of biologic agents in patients with psoriasis vulgaris. Br. J. Dermatol., 2015, 172, p. 244–252.

17. GRUNDY, S. M., BREWER, H. B. Jr, CLEEMAN, J. I. et al. Definition of Metabolic Syndrome: report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Arterioscler. Thromb. Vasc. Biol., 2004, 24, p. e13–e18.

18. GUPTA, R., DEBBANEH, M. G., LIAO, W. Genetic Epidemiology of Psoriasis. Curr. Dermatol. Rep., 2014, 3, p. 61–78.

19. HÄGG, D., ERIKSSON, M., SUNDSTRÖM, A. et al. The Higher Proportion of Men with Psoriasis Treated with Biologics May Be Explained by More Severe Disease in Men. PLoS One, 2013, 5, e63619.

20. HORN, E. J., FOX, K. M., PATEL, V. et al. Are patients with psoriasis undertreated? Results of National Psoriasis Foundation survey. J. Am. Acad. Dermatol., 2007, 57, p. 957–962.

21. HUERTA, C., RIVERO, E., RODRÍGUEZ, L. A. Incidence and risk factors for psoriasis in the general population. Arch. Dermatol., 2007, 143, p. 1559–1565.

22. ISKANDAR, I. Y., AAHCROFT, D. M., WARREN, R. B. et al. Demographics and disease characteristics of patients with psoriasis enrolled in the British Association of Dermatologists Biologic Interventions Register. Br. J. Dermatol., 2015, 173, p. 510–518.

23. KAYE, J. A., LI, L., JICK, S. S. Incidence of risk factors for myocardial infarction and other vascular diseases in patients with psoriasis. Br. J. Dermatol., 2008, 159, 895–902.

24. KIMBALL, A. B., GLADMAN, D., GELFLAND, J. M. et al. National Psoriasis Foundation clinical consensus on psoriasis comorbidities and recommendations for screening. J. Am. Acad. Dermatol., 2008, 58, p. 1031–42.

25. LEBWOHL, M. G., BACHELEZ, H., BARKER, J. et al. Patient perspectives in the management of psoriasis: Results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. J. Am. Acad. Dermatol., 2014, 70, p. 871–881.

26. LECLUSE, L. L., NALDI, L., STERN, R. S. et al. National registries of systemic treatment for psoriasis and the European ‘Psonet’ initiative. Dermatology, 2009, 218, p. 347–356.

27. MA, C., HARSKAMP, C. T., ARMSTRONG, E. J. et al. The association between psoriasis and dyslipidaemia: a systematic review. Br. J. Dermatol., 2013, 168, p. 486–495.

28. MAZA, A., RICHARD, M. A., AUBIN, F. et al. Significant Delay in the Introduction of Systemic Treatment of Moderate to Severe Psoriasis Severe Psoriasis. Br. J. Dermatol., 2012, 167, p. 643–648.

29. MEASE, P. J., GLADMAN, D. D., PAPP, K. A. et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J. Am. Acad. Dermatol., 2013, 69, p. 729–735.

30. MEIJER, K., DE VRIES, M., AL-LAHHAM, S. et al. Human Primary Adipocytes Exhibit Immune Cell Function: Adipocytes Prime Inflammation Independent of Macrophages. PLoS ONE, 2011, 6, e17154.

31. MENTER, A., KORMAN, N. J., ELMENTS, C. A. et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J. Am. Acad. Dermatol., 2009, 61, p. 451–485.

32. NALDI, L., CHATENOUD, L., LINDER, D. et al. Cigarette smoking, body mass index, and stressful life events as risk factors for psoriasis: results from an Italian case-control study. J. Invest. Dermatol., 2005, 125, p. 61–67.

33. NALDI, L., CONTI, A., CAZZANIGA, S. et al. Diet and physical exercise in psoriasis: a randomized controlled trial. Br. J. Dermatol., 2014, 170, p. 634–642.

34. NATALI, A., TOSCHI, E., BALDEWEG, S. et al. Clustering of insulin resistance with vascular dysfunction and low-grade inflammation in type 2 diabetes. Diabetes, 2006, 55, p. 1133–1140.

35. NEIMANN, A. L., SHIN, D. B., WANG, X. et al. Prevalence of cardiovascular risk factors in patients with psoriasis. J. Am. Acad. Dermatol., 2006, 55, p. 829–835.

36. Obesity Update, OECD 2014, dostupné 2.11.2015: http://www.oecd.org/health/Obesity-Update-2014.pdf

37. ORMEROD, A. D., AUGUSTIN, M., BAKER, C. et al. Challenges for synthesising data in a network of registries for systemic psoriasis therapies. Dermatology, 2012, 3, p. 236–243.

38. PARISI, R., SYMMONS, D. P. M., GRIFFITHS, C. E. et al. 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., 2013, 133, p. 377–385.

39. POULIN, Y., PAPP, K. A., WASEL, N. R. et al. A Canadian online survey to evaluate awareness and treatment satisfaction in individuals with moderate to severe plaque psoriasis. Int. J. Dermatol., 2010, 49, p. 1368–1375.

40. QUERSHI, A. A., CHOI, H. K., SETTY, A. R. et al. Psoriasis and the risk of diabetes and hypertension: a prospective study of US female nurses. Arch. Dermatol., 2009, 145, p. 379–382.

41. RACHAKONDA, T. D., SCHUPP, C. W., ARMSTRONG, A. W. J. Psoriasis prevalence among adults in the United States. Am. Acad. Dermatol., 2014, 70, p. 512–516.

42. RANZA, R., CARNEIRO, S., QUERSHI, AA. et al. Prevalence of psoriatic arthritis in a large cohort of Brazilian patients with psoriasis. J. Rheumatol., 2015, 42, p. 829–834.

43. RAYCHAUDHURI, S. P., GROSS, J. Psoriasis risk factors: role of lifestyle practices. Cutis, 2000, 66, p. 348–352.

44. REICH, K., KRÜGER, K., MÖSSNER, R. et al. Epidemiology and clinical pattern of psoriatic arthritis in Germany: a prospective interdisciplinary epidemiological study of 1511 patients with plaque-type psoriasis. Br. J. Dermatol., 2009, p. 160: 1040–1047.

45. REICH, K., MROWIETZ, U., RADTKE, M. A. et al. Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest. Arch. Dermatol. Res., 2015, 307, p. 875–883.

46. RENCZ, F., KEMÉNY, L., GAJDÁCSI, J. Z. et al. Use of biologics for psoriasis in Central and Eastern European countries. J. Eur. Acad. Dermatol. Venereol., 2015, 29, p. 2222–2230.

47. RONTI, T., LUPATELLI, G., MANNARINO, E. The endocrine function of adipose tissue: an update. Clin. Endocrinol, 2006, 64, p. 355–365.

48. SCHMITT-EGENOLF, M. Psoriasis therapy in real life: the need for registries. Dermatology, 2006, 213, p. 327–330.

49. SPELMAN, L., SU, J. C., FERNANDES-PEŇAS, P. et al. Frequency of undiagnosed psoriatic arthritis among psoriasis patients in Australian dermatology practice. J. Eur. Acad. Dermatol. Venereol., 2015, 29, p. 2184–2191.

50. Státní ústav pro kontrolu léčiv, dostupné 10.10.2016: http://www.sukl.cz/modules/medication/search.php.

51. TAKAHASHI, H., TSUJI, H., HASHIMOTO, Y. Serum cytokines and growth factor levels in Japanese patients with psoriasis. Clin. Exp. Dermatol., 2010, 35, p. 645–649.

52. ÚZIS ČR: Aktuální informace č. 2/2015, dostupné 10.10.2016: www.uzis.cz/system/files/ai_2015_02.pdf).

53. VAN DE KERKHOF, P. C., REICH, K. et al. Physician perspectives in the management of psoriasis and psoriatic arthritis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis survey. J. Eur. Acad. Dermatol. Venereol., 2015, 29, p. 2002–2010.

54. WOLK, K., MALLBRIS, L., LARSSON, P. et al. Excessive body weight and smoking associates with a high risk of onset of plaque psoriasis. Acta Derm. Venereol., 2009, 89, p. 492–497.

55. World Health Organisation, BMI classification, dostupné 2.11.2015: http://apps.who.int/bmi/index.jsp?introPage=intro_3.html.

56. Zpráva o zdraví obyvatel České republiky. Ministerstvo zdravotnictví České republiky, Praha 2014, dostupné 10.10.2016: http://www.mzcr.cz/verejne/dokumenty/zprava-o-zdravi-obyvatel-ceske-republiky2014-_9420_3016_5.html).

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