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Ustekinumab Efficacy and Safety in Children with Plaque, Erythrodermic and Palmoplanar Forms of Psoriasis: Retrospective Cohort Study

https://doi.org/10.15690/vsp.v19i6.2153

Abstract

Background. The study of psoriasis biological therapy aspects in children has certain topicality due to the small number and disunity of individual observations and the lack of special registers for pediatric patients.

Objective. Our aim was to study ustekinumab efficacy and safety in children with plaque (PP), erythrodermic (EP) and palmoplanar (PPP) forms of psoriasis.

Methods. The analysis of ustekinumab efficacy and safety has been carrying out for 1 year. The evaluation of therapy efficacy was based on definition of improvement of PASI scores (PASI 75, PASI 90 and PASI 100) on the 16th, 28th, 40th and 52nd weeks of follow-up and children's dermatology life quality index (CDLQI). Ustekinumab therapy safety analysis was based on registration and evaluation of adverse effects. Results. The study included 67 children with PP, EP and PPP aged 12 to 18 years. PP group results: the PASI 75 response at the 52nd week of therapy was observed in 35 children (100%), PASI 90 — in 33 (94%), PASI 100 — in 30 (86%). EP group results: 10 patients (56%) have reached PASI 75 on the 16th week, while none of patients have improved to PASI 90 and PASI 100 scores. The PASI 75 response at the 52nd week of therapy was observed in 18 children (100%), PASI 90 — in 17 (94%), PASI 100 — in 7 (39%). Only 1 patient (7%) with PPP has showed the score decrease to PASI 75 on the 16th week. Adverse effects were reported in 2 patients.

Conclusion. Ustekinumab is the effective and safe treatment for moderate and severe forms of PP and EP in children, and it can also be considered as one of the alternative methods for PPP treatment in pediatrics.

About the Authors

Nikolay N. Murashkin
National Medical Research Center of Children’s Health; Research Institute of Pediatrics and Children’s Health in “Central Clinical Hospital of the Russian Academy of Sciences”; Sechenov First Moscow State Medical University (Sechenov University); Central State Medical Academy of Department of Presidential Affairs
Russian Federation
Moscow
Disclosure of interest:

Nikolay N. Murashkin — receiving research grants from pharmaceutical companies Jansen, Eli Lilly, Novartis, AbbVie, Pfizer, Amryt Pharma plc. Scientific consultant of Galderma, Pierre Fabre, Bayer, LEO Pharma, Pfizer, AbbVie



Eduard T. Ambarchian
National Medical Research Center of Children’s Health; Research Institute of Pediatrics and Children’s Health in “Central Clinical Hospital of the Russian Academy of Sciences”; Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Moscow
Disclosure of interest:

Eduard T. Ambarchian — receiving research grants from pharmaceutical companies Eli Lilly, Novartis, AbbVie, Pfizer, Amryt Pharma plc, scientific consultant of Johnson & Johnson company



Roman V. Epishev
National Medical Research Center of Children’s Health; Research Institute of Pediatrics and Children’s Health in “Central Clinical Hospital of the Russian Academy of Sciences”
Russian Federation
Moscow
Disclosure of interest:

Alexander I. Materikin, Roman V. Epishev — scientific consultants of Eli Lilly, Novartis companies



Alexander I. Materikin
National Medical Research Center of Children’s Health
Russian Federation
Moscow
Disclosure of interest:

Alexander I. Materikin, Roman V. Epishev — scientific consultants of Eli Lilly, Novartis companies



Leonid A. Opryatin
National Medical Research Center of Children’s Health
Russian Federation
Moscow
Disclosure of interest:

The other contributors confirmed the absence of a reportable conflict of interests



Roman A. Ivanov
National Medical Research Center of Children’s Health
Russian Federation
Moscow
Disclosure of interest:

The other contributors confirmed the absence of a reportable conflict of interests



Daria S. Kukoleva
National Medical Research Center of Children’s Health
Russian Federation
Moscow
Disclosure of interest:

The other contributors confirmed the absence of a reportable conflict of interests



Marina Y. Pomazanova
National Medical Research Center of Children’s Health; Clinical Dermatovenerologic Dispensary
Russian Federation
Moscow, Krasnodar
Disclosure of interest:

The other contributors confirmed the absence of a reportable conflict of interests



Daria G. Kuptsova
National Medical Research Center of Children’s Health
Russian Federation
Moscow
Disclosure of interest:

The other contributors confirmed the absence of a reportable conflict of interests



Yana V. Kozyr
Kuban State Medical University
Russian Federation
Krasnodar
Disclosure of interest:

The other contributors confirmed the absence of a reportable conflict of interests



Andrey L. Bakulev
Saratov State Medical University n.a. V.I. Razumovsky
Russian Federation
Saratov
Disclosure of interest:

Andrey L. Bakulev — conducting clinical trials in cooperation with MSD, Jansen, AbbVie, LEO Pharma, UCB, BIOCAD, Dr. Reddy's Laboratories Ltd., Novartis, AMGen, Galderma, VEROPHARM, Pfizer, UCB. Expert data evaluation for Eli Lilly, Jansen, AbbVie, LEO Pharma, UCB, BIOCAD, Novartis, AMGen, Galderma, Zeldis Pharma. Reading reports for Eli Lilly, Bayer, MSD, Jansen, AbbVie, LEO Pharma, UCB, BIOCAD, Dr. Reddy's Laboratories Ltd., Novartis, Galderma, VEROPHARM, Pfizer, JADRAN (JGL), Zeldis Pharma



References

1. Bronckers IMGJ, Paller AS, Van Geel MJ, et al. Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities. Paediatr Drugs. 2015;17(5):373–384. doi: 10.1007/s40272-015-0137-1.

2. Michalek IM, Loring B, John SM. A systematic review of worldwide epidemiology of psoriasis. J Eur Acad Dermatol Venereol. 2017; 31(2):205–212. doi: 10.1111/jdv.13854.

3. Augustin M, Glaeske G, Radtke MA, et al. Epidemiology and comorbidity of psoriasis in children. Br J Dermatol. 2010;162(3): 633–636. doi: 10.1111/j.1365-2133.2009.09593.x.

4. Kruglova LS, Tamrazova OB, Ivanov RA. Psoriasis in childhood: clinical course and management tactics. Journal of International Medicine. Pediatrics/Neonatology. 2019;2(36):19–25. (In Russ).

5. Shah KN. Diagnosis and treatment of pediatric psoriasis: current and future. Am J Clin Dermatol. 2013;14(3):195–213. doi: 10.1007/s40257-013-0026-8.

6. Tollefson MM. Diagnosis and management of psoriasis in children. Pediatr Clin North Am. 2014;61(2):261–277. doi: 10.1016/j.pcl.2013.11.003.

7. Thomas J, Parimalam K. Treating pediatric plaque psoriasis: challenges and solutions. Pediatric Health Med Ther. 2016;21(7): 25–38. doi: 10.2147/PHMT.S75834.

8. Lee CS, Koo J. A review of acitretin, a systemic retinoid for the treatment of psoriasis. Expert Opin Pharmacother. 2005;6(10): 1725–1734. doi: 10.1517/14656566.6.10.1725.

9. Van Geel MJ, Oostveen AM, Hoppenreijs E.P, et al. Methotrexate in pediatric plaque-type psoriasis: long-term daily clinical practice results from the Child-CAPTURE registry. J Dermatolog Treat. 2015;26(5):406–412. doi: 10.3109/09546634.2014.996515.

10. Di Lernia V, Stingeni L, Boccaletti V, et al. Effectiveness and safety of cyclosporine in pediatric plaque psoriasis: a multicentric retrospective analysis. J Dermatolog Treat. 2016;27(5):395–398. doi: 10.3109/09546634.2015.1120852.

11. Paller AS, Siegfried EC, Langley RG, et al. Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis. J Am Acad Dermatol. 2016;74(2):280–287. doi: 10.1016/j.jaad.2015.09.056.

12. Di Lernia V. Adalimumab for treating childhood plaque psoriasis: a clinical trial evaluation. Expert Opin Biol Ther. 2017;17(12): 1553–1556. doi: 10.1080/14712598.2017.1369950.

13. Kruglova LS, Hotko AA, Petriy MA. Early prescription of genetically engineered biological therapy for patients with psoriasis. Medical Alphabet. Dermatology. 2019;1(7):25–28. (In Russ).

14. Benson JM, Peritt D, Scallon BJ, 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(6):535–545. doi: 10.4161/mabs.3.6.17815.

15. Tsai TF, Ho JC, Song M, et al. 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. 2011;63(3):154–163. doi: 10.1016/j.jdermsci.2011.05.005.

16. Nast A, Jacobs A, Rosumeck S, Werner RN. Efficacy and safety of systemic long-term treatments for moderate-to-severe psoriasis: A systematic review and meta-analysis. J Invest Dermatol. 2015;135(11):2641–2648. doi: 10.1038/jid.2015.206.

17. Strober BE, Bissonnette R, Fiorentino D, et al. Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR]). J Am Acad Dermatol. 2016;74(5):851–861.e4. doi: 10.1016/j.jaad.2015.12.017.

18. Gonzalez-Barreto RM, Rochet NM, Nevares-Pomales OW, ColonFontanez F. Excellent response to ustekinumab in a 9-year-old girl with severe psoriasis. Pediatr Dermatol. 2018;35(1):e76–e78. doi: 10.1111/pde.13344.

19. Philipp S, Menter A, Nikkels AF, et al. Ustekinumab for the treatment of moderate-to-severe plaque psoriasis in pediatric patients ( 6 to < 12 years of age): efficacy, safety, pharmacokinetic, and biomarker results from the open-label CADMUS Jr study. Br J Dermatol. 2020;183(4):664–672. doi: 10.1111/bjd.19018.

20. Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(Suppl 2):ii65–ii68. doi: 10.1136/ard.2004.031237.

21. Lewis-Jones MS, Finlay AY. The Children’s Dermatology Life Quality Index (CDLQI): initial validation and practical use. Br J Derma tol. 1995;132(6):942–949. doi:10.1111/j.1365-2133.1995.tb16953.x.

22. Blegvad C, Nybo Andersen AM, Groot J, et al. Clinical characteristics including cardiovascular and metabolic risk factors in adolescents with psoriasis. J Eur Acad Dermatol Venereol. 2020; 34(7):1516–1523. doi: 10.1111/jdv.16229.

23. Lysell J, Tessma M, Nikamo P, et al. Clinical characterisation at onset of childhood psoriasis — A cross sectional study in Sweden. Acta Derm Venereol. 2015;95(4):457–461. doi: 10.2340/00015555-1986.

24. Zorko MS, Tockova O. Retrospective study of childhood psoriasis. In: Psoriasis gene to clinic. 8th International Congress. London, U.K., 30th November — 2nd December 2017. pp. 124–125.

25. Wu Y, Lin Y, Liu HJ, et al. Childhood psoriasis: a study of 137 cases from central China. World J Pediatr. 2010;6(3):260–264. doi: 10.1007/s12519-010-0213-0.

26. Kwon HH, Na SJ, Jo SJ, Youn JI. Epidemiology and clinical features of pediatric psoriasis in tertiary referral psoriasis clinic. J Dermatol. 2012;39(3):260–264. doi: 10.1111/j.1346-8138.2011.01452.x.

27. Choon SE, Ngim CF, Supramaniam P, et al. Clinicoepidemiological profile, including body mass index of Malaysian children with psoriasis. Med J Malaysia. 2016;71(4):171–176.

28. Tollefson MM, Crowson CS, McEvoy MT, Maradit Kremers H. Incidence of psoriasis in children: a population-based study. J Am Acad Dermatol. 2010;62(6):979–987. doi: 10.1016/j.jaad.2009.07.029.

29. Murashkin NN, Kozhevnikova OV, Materikin AI. The Function of Large Vessels in Normal-Weight and Overweight Children With Psoriasis During Methotrexate Therapy. Pediatricheskaya farmakologiya — Pediatric pharmacology. 2018; 15(6):447–454. (In Russ). doi: 10.15690/pf.v15i6.1982.


Review

For citations:


Murashkin N.N., Ambarchian E.T., Epishev R.V., Materikin A.I., Opryatin L.A., Ivanov R.A., Kukoleva D.S., Pomazanova M.Y., Kuptsova D.G., Kozyr Ya.V., Bakulev A.L. Ustekinumab Efficacy and Safety in Children with Plaque, Erythrodermic and Palmoplanar Forms of Psoriasis: Retrospective Cohort Study. Current Pediatrics. 2020;19(6):531-537. (In Russ.) https://doi.org/10.15690/vsp.v19i6.2153

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