#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Efficacy of Biological Treatment of Moderate to Severe Psoriasis – Analysis from the BIOREP Registry


Authors: M. Kojanová 1;  J. Fialová 1;  P. Cetkovská 2;  S. Gkalpakiotis 3;  J. Štork 1;  P. Arenberger 3;  A. Machovcová 4;  T. Doležal 5;  D. Štrosová 5;  B. Velacková 5;  Biorep Skupina
Authors‘ workplace: 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;  Dermatovenerologické oddělení FN v Motole, Praha, primář MUDr. Alena Machovcová, Ph. D., MBA 4;  Value Outcomes, Praha 5
Published in: Čes-slov Derm, 96, 2021, No. 2, p. 73-79
Category: Pharmacologyand Therapy, Clinical Trials

Overview

Objective: Evaluation of the effectiveness of biological treatment of psoriasis according to the achievement of PASI 75, 90 and 100 in each group of biologics.

Methods: A retrospective evaluation of patients diagnosed with plaque psoriasis from the BIOREP registry, who were treated with anti-TNF, anti-IL-12/23, anti-IL-17, or anti-IL-23 drugs during the registry follow-up period was performed.

Results: The total study population of 2,873 patients included 1,832 males (63.8%) and 1,041 females (36.2%). The mean age at the time of diagnosis was 24.8 ± 13.5 years, the mean age at the time of initiation of the first biologic was 46.0 ± 13.0 years. The average time from the diagnosis of psoriasis to the first biological therapy was 21.2 ± 12.1 years. Psoriatic arthritis was diagnosed in 1,008 (35.1%) patients, 70.7% of patients had at least one comorbidity and 72.9% of patients with overweight or obese. A total of 4,938 treatment series were recorded in the evaluated patients; anti-TNF (2,961 series, 60.0%), anti-IL-12/23 (626 series, 12.7%), anti-IL-17 (1,008 series, 20.4%) and anti-IL-23 (343 series, 6.9%). After 3–4 months of treatment, PASI 75 was achieved in 64.9% of cases, PASI 90 in 42.5% of cases and PASI 100 in 23.4% of cases with a further increase at 6 months (PASI 75, 90 and 100 in 76,9%, 55.6% and 32.7%, respectively) and maintaining response until 24 months of treatment. The higher achievement of PASI75/90/100 was in the group treated with anti-IL-17 and anti-IL-23 even with a faster response rate compared to anti-TNF and anti IL-12/23. A higher achievement of PASI75/90/100 was observed in naive patients (with no previous biological treatment).

Conclusion: The analysis of the BIOREP registry confirmed data from registries of other countries as well as meta-analyzes of clinical studies. Although anti-TNF drugs have made significant advances in the treatment of psoriasis and adalimumab is still the most widely used drug, newer molecules provide higher efficacy. Our analysis demonstrates a significant response in all PASI categories as well as a faster response to anti-IL-23 and anti-IL-17 drugs compared to older groups of biologics. Early and effective treatment of severe plaque psoriasis is important not only to improve quality of life and to reduce the risk of comorbidities, but also to achieve the highest response and the consequent long-term persistence on the treatment.

Keywords:

Psoriasis – PASI – biological therapy – registries – BIOREP


Sources

  1. AMATORE, F., VILLANI, A. P., TABUER, M. et al. Psoriasis Research Group of the French Society of Dermatology. French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol, 2019, 33, p. 464–483.

  2. BENSON, J. M., PERITT, D., SCALLON, B. J. et al. Discovery and mechanism of ustekinumab: a human monoclonal antibody targeting interleukin-12 and interleukin-23 for treatment of immune-mediated disorders. MAbs, 2011, 3, p. 535–545. 

  3. CETKOVSKÁ, P., KOJANOVÁ, M., ARENBERGER, P. et al. Současný stav moderní léčby psoriázy – aktualizovaná doporučení ČDS JEP k cílené léčbě závažné chronické psoriázy. Čes-slov Derm, 2019, 94, p. 135–164.

  4. GASPARI, A. A., TYRING, S. New and emerging biologic therapies for moderate-to-severe plaque psoriasis: mechanistic rationales and recent clinical data for IL-17 and IL-23 inhibitors. Dermatologic therapy, 2015, 28, p. 179–193.

  5. GOFF, K., KARIMKHANI, C., BOYERS, L. et al. The global burden of psoriatic skin disease. Br J Dermatol, 2015, 172, p. 1665–1668.

  6. GORDON, K. B., STROBER, B., LEBWOHL, M. et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two doubleblind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet, 2018, 392, p. 650–661.

7.    GRAIER, T., SALMHOFER, W., JONAK, C. et al. Biologic drug survival rates in the era of anti-Il-17 antibodies: a time period-adjusted registry analysis. Br J Dermatol, 2020, Dec 1, doi: 10.1111/bjd.19701. Epub ahead of print.

  8. KOJANOVA, M., CETKOVSKA, P., STROSOVA, D. et al. Real-World Evidence From More Than 1000 Patients Treated With Adalimumab For Moderate-to-Severe Psoriasis in the Czech Republic. Dermatol Ther (Heidelb), 2021, Mar 5, doi: 10.1007/s13555-021-00499-8. Epub ahead of print.

  9. KOJANOVA, M., FIALOVA, J., CETKOVSKA, P. et al. Demographic data, comorbidities, quality of life, and survival probability of biologic therapy associated with sex-specific differences in psoriasis in the Czech Republic. Dermatol Ther, 2021, Feb, 3: e14849. doi: 10.1111/dth.14849. Epub ahead of print.

10. KOJANOVA, M., FIALOVA, J., GKALPAKIOTIS, S. et al. Registr biologické/cílené léčby BIOREP – Souhrnná zpráva za rok 2020. Čes-slov Derm, 2021, 96(1), v tisku.

11. LIM, P. T, WANG, S. H., CHI, C. C. Drug survival of biologics in treating psoriasis: a meta-analysis of real-world evidence. Sci Rep, 2018, 30, p. 16068. doi: 10.1038/s41598-018-34293-y.

12. LOFT, N., EGEBERG, A., RASMUSSEN, M. K. et al. Response to Biologics During the First Six Months of Therapy in Biologic-naïve Patients with Psoriasis Predicts Risk of Disease Flares: A Danish Nationwide Study. Acta Derm Venereol, 2021, 101(1), adv00357.

13. MAHIL, S. K., WILSON, N., DAND, N. et al. Psoriasis treat to target: defining outcomes in psoriasis using data from a real-world, population-based cohort study (the British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR). Br J Dermatol, 2020, 182, p. 1158–1166.

14. MENTER, A., GOTTLIEB, A., FELDMAN, S. R. O. V. et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol, 2008, 58, p. 826–850.

15. MROWIETZ, U., DE JONG, E., KRAGBALLE, K. et al. A consensus report on appropriate treatment optimization and transitioning in the management of moderate-to-severe plaque psoriasis. J Eur Acad Dermatol Venereol, 2014, 28, p. 438–453.

16. NAST, A., SMITH, C., SPULS, P. I. et al. EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris – Part 1: treatment and monitoring recommendations. J Eur Acad Dermatol Venereol, 2020, 34, p. 2461–2498.

17. NAST, A., SPULS, P. I., VAN DER KRAAIJ, G. et al. European S3-Guideline on the systemic treatment of psoriasis vulgaris – Update Apremilast and Secukinumab – EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol, 2017, 31, p. 1951–1963.

18. OBRADORS, M., BLANCH, C., COMELLAS, M. et al. Health-related quality of life in patients with psoriasis: a systematic review of the European literature. Quality of Life Research, 2016, 25, p. 2739–2754. 

19. ÖZKUR, E., KIVANC ALTUNAY, I., OGUZ TOAPL, I. et al. Switching Biologics in the Treatment of Psoriasis: A Multicenter Experience. Dermatology, 2021, 237, p. 22–30.

20. PAPP., K. A., LEONARDI, C., MENTER, A. et al. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med, 2012, 366, p. 1181–1189.

21. PARISI, R., SYMMONS, D. P. M., GRIFFITRHS, C. E. M. et al. Global Epidemiology of Psoriasis: A Systematic Review of Incidence and Prevalence. J Investig Dermatol, 2013, 133, p. 377–385.

22. RAPP, S. R. O. V., FELDMAN, S. R. O. V., EXUM, M. L. et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol, 1999, 41, p. 401–407.

23. REICH, K., ARMSTRONGM A., FOLEY, P. et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol, 2017, 76, p. 418–431.

24. REICH, K., MROWIETZ, U. Treatment goals in psoriasis. J Dtsch Dermatol Ges, 2007, 5, p. 566–574. 

25. REICH, K., PAPP, K. A., BLAUVELT, A. et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet, 2017, 390, p. 276–288.

26. SAWYER, L. M., MALOKKTI, K., SABRY-GANT, K. et al. Assessing the relative efficacy of interleukin-17 and interleukin-23 targeted treatments for moderate-to-severe plaque psoriasis: A systematic review and network meta-analysis of PASI response. PLoS One, 2019, 14, p. e0220868.

27. SENESCHAL., J., LACOUR, J. P., BEWLEY, A. et al. A multinational, prospective, observational study to estimate complete skin clearance in patients with moderate-to-severe plaque PSOriasis treated with BIOlogics in a REAL world setting (PSO-BIO-REAL). J Eur Acad Dermatol Venereol, 2020, 34, p. 2566–2573.

28.  SÚKL Dostupné na www: https://www.sukl.cz/modules/medication/search.php (dostupné 28. 2. 2021).

29. TORRES, T., PUIG, L. Treatment goals for psoriasis: Should PASI 90 become the standard of care? Actas dermo-sifiliograficas, 2015, 106, p. 155–157.

30. WARREN, R. B., SMITCH, C. H., YIU, Z. Z. N. et al. Differential drug survival of biologic therapies for the treatment of psoriasis: a prospective observational cohort study from the British Association of Dermatologists Biologic Interventions Register (BADBIR). J Invest Dermatol, 2015, 135, p. 2632–2640.

31. WEISS, S. C., KIMBALL, A. B., LIEWEHR, D. J. et al. Quantifying the harmful effect of psoriasis on health--related quality of life. J Am Acad Dermatol, 2002, 47, p. 512–518.

32.   WINTERFIELD, L. S., MENTER, A., GORDON, K. et al. Psoriasis treatment: current and emerging directed therapies. Ann Rheum Dis, 2005, 64(suppl 2), p. ii87–ii90.

33. World Health Organization. Global Report in Psoriasis. 2016. Global report on psoriasis. Dostupné na www: www.who.int, dostupné 28.2.2021.

34. XU, S., GAO, X., DENG., J. et al. Comparative efficacy and safety of biologics in moderate to severe plaque psoriasis: a multiple-treatments meta-analysis. J Dtsch Dermatol Ges, 2021, 19, p. 47–56.

Labels
Dermatology & STDs Paediatric dermatology & STDs
Topics Journals
Login
Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account

#ADS_BOTTOM_SCRIPTS#