Systemic Psoriasis Treatment at an Early Age (Part II): Issues of Biological Therapy

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Abstract

The authors present an overview of the present day knowledge of methods of biological therapy used for treatment of severe psoriasis at an early age. Data is presented on efficiency, safety, required monitoring of clinical and laboratory performance, specifics of vaccination during the treatment of children with genetically engineered biological drugs. Data is presented on the authors’ own clinical observations of 10 adolescents who were administered the preparation of ustekinumab. The objective of the observational study was assessment of efficiency and safety of application of ustekinumab for treatment of severe psoriasis with children over 12 years of age. Materials and Methods. The observation covered 10 children, their average age being 15±2.8 years old, the PASI index 39.3±9.5, who were administered ustekinumab at a dose of 45 mg under a standard administration regimen. Results. The therapeutic effect was assessed based on the PASI index, which was found to decrease by 75% with 6 adolescents, and by 90% with 4 adolescents as soon as by week 14 of the therapy. As is shown by the follow-up observation, the skin pathological process was completely resolved with 80% of adolescents after 3 injections of ustekinumab, and with 100% after 4 injections. Conclusion. The preparation of ustekinumab is efficient and safe for treatment of psoriasis at an early age. As based on the PASI index as the main criterion of assessment of treatment efficiency, ustekinumab (Stelara) is the medicine of choice for treatment of severe forms of the disease from the age of 12 years old.

About the authors

L. S. Namazova-Baranova

National Medical Research Center of Children’s Health of the Ministry of Health of the Russian Federation

Author for correspondence.
Email: fake@neicon.ru

Academician of the Russian Academy of Sciences, Deputy Director for Research, Head of the Scientific Research Institute of Pediatrics

Россия

N. N. Murashkin

National Medical Research Center of Children’s Health of the Ministry of Health of the Russian Federation;
Central State Medical Academy, Administration of the President of the Russian Federation;
I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation

Email: m_nn2001@mail.ru

D.Sci. (Medicine), Head of the Department of Dermatology, National Medical Research Center of Children’s Health of the Ministry of Health of the Russian Federation; Prof., Department of Dermatovenereology and Cosmetology, Central State Medical Academy, Administration of the President of the Russian Federation; Prof., Chair of Pediatrics and Pediatric Rheumatology, I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation

Россия

E. T. Ambarchian

National Medical Research Center of Children’s Health of the Ministry of Health of the Russian Federation

Email: fake@neicon.ru

MD, Researcher of the Laboratory of Skin Pathology in Children of the Department of Scientific Research in Pediatrics, Doctor, Department of Dermatology

Россия

A. I. Materikin

National Medical Research Center of Children’s Health of the Ministry of Health of the Russian Federation

Email: fake@neicon.ru

MD, Doctor, Department of Dermatology

Россия

References

  1. Napolitano M., Megna M., Balato A. et al. Systemic Treatment of Pediatric Psoriasis: A Review. Dermatol. Ther. (Heidelb.) 2016;6(2):125–142.
  2. Баранов А. А., Намазова-Баранова Л. С., Мурашкин Н. Н. и др. Федеральные клинические рекомендации по оказанию медицинской помощи детям с псориазом. 2016. С. 5–10. [Baranov A. A., Namazova-Baranova L. S., Murashkin N. N. et al. Federal Clinical Guidelines of Care for the Management for Children with Psoriasis. 2016. P. 5–10.]
  3. Sanclemente G., Murphy R., Contreras J. et al. Anti-TNF Agents for Paediatric Psoriasis. Cochrane Database Syst. Rev. 2015;(11):CD010017.
  4. Paller A. S., Siegfried E. C., Langley R. G. et al. Etanercept Treatment for Children and Adolescents with Plaque Psoriasis. N. Engl. J. Med. 2008;358(3):241–251.
  5. Paller A. S., Siegfried E. C., Eichenfield L. F. et al. Long-Term Etanercept in Pediatric Patients with Plaque Psoriasis. J. Am. Acad. Dermatol. 2010;63(5):762–768.
  6. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Summary of Opinion (Post Authorisation) for Enbrel (Etanercept). July 21, 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000262/WC50010924.pdf
  7. Paller A. S., Siegfried E. C., Langley R. G. 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.
  8. Beikert F. C., Augustin M., Radtke M. A. Etanercept in Juvenile Psoriasis. Hautarzt. 2012;63(5):406–410.
  9. Bellodi Schmidt F., Shah K. N. Biologic Response Modifiers and Pediatric Psoriasis. Pediatr. Dermatol.. 2015;32(3):303–320.
  10. Rott S., Kuster R. M., Mrowietz U. Successful Treatment of Severe Psoriatic Arthritis with Infliximab in an 11-Year-Old Child Suffering from Linear Psoriasis along Lines of Blaschko. Br. J. Dermatol. 2007;157(1):191–192.
  11. Skrabl-Baumgartner A., Weger W., Salmhofer W., Jahnel J. Childhood Generalized Pustular Psoriasis: Longtime Remission with Combined Infliximab and Methotrexate Treatment. Pediatr. Dermatol. 2015;32(1):13–14.
  12. Papp K., Thaçi D., Marcoux D. et al. Efficacy and Safety of Adalimumab Every Other Week versus Methotrexate Once Weekly in Children and Adolescents with Severe Chronic Plaque Psoriasis: a Randomised, Double-Blind, Phase 3 Trial. Lancet 2017;390(10089):40–49.
  13. Leonardi C. L., Kimball A. B., Papp K. A. et al. 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). Lancet 2008;371(9625):1665–1674.
  14. Papp K. A., Langley R. G., Lebwohl M. et al. 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). Lancet 2008;371(9625):1675–1684.
  15. Kimball A. B., Papp K. A., Wasfi Y. et al. 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. 2013;27(12):1535–1545.
  16. Gordon K. B., Papp K. A., Langley R. G. et al. Long-Term Safety Experience of Ustekinumab in Patients with Moderate to Severe Psoriasis (Part II of II): Results from Analyses of Infections and Malignancy from Pooled Phase II and III Clinical Trials. J. Am. Acad. Dermatol. 2012;66(5):742–751.
  17. Lebwohl M., Leonardi C., Griffiths C. E. et al. Long-Term Safety Experience of Ustekinumab in Patients with Moderate-to-Severe Psoriasis (Part I
  18. of II): Results from Analyses of General Safety Parameters from Pooled Phase 2 and 3 Clinical Trials. J. Am. Acad. Dermatol. 2012;66(5):731–741.
  19. Reich K., Papp K. A., Griffiths C. E. et al. 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. 2012;11(3):300–312.
  20. Fotiadou C., Lazaridou E., Giannopoulou C., Ioannides D. Us-tekinumab for the Treatment of an Adolescent Patient with Recalcitrant Plaque Psoriasis. Eur. J. Dermatol. 2011;21(1):117–118.
  21. Abu Hilal M., Ho N. Successful Treatment of Severe Psoriasis in an Adolescent with Ustekinumab. Pediatr. Dermatol. 2015;32(3):377–380.
  22. Dixit S., Shumack S., Fischer G. Ustekinumab in the Treatment of Severe Paediatric Psoriasis. Australas. J. Dermatol. 2013;54(2):147.
  23. Landells I., Marano C., Hsu M.C. et al. Ustekinumab in Adolescent Patients Age 12 to 17 Years with Moderate-to-Severe Plaque Psoriasis: Results of the Randomized Phase 3 CADMUS Study. J. Am. Acad. Dermatol. 2015;73(4):594–603.

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Copyright (c) 2017 Namazova-Baranova L.S., Murashkin N.N., Ambarchian E.T., Materikin A.I.

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