Certolizumab pegol: new opportunities for treatment of moderate to severe plaque psoriasis

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Abstract

Tumor necrosis factor alpha (TNF-α) is one of the key inflammatory cytokines in the pathogenesis of psoriasis and psoriatic arthritis, and its inhibition with genetically engineered biological drugs ensures control of the main symptoms of these diseases. Certolizumab pegol is a PEGylated (linked to polyethylene glycol) Fab’ fragment of a monoclonal antibody that inhibits human TNF-α. It is approved for treatment of moderate to severe plaque psoriasis and psoriatic arthritis. This review summarizes the results of randomized clinical trials of efficacy and safety of certolizumab pegol in plaque psoriasis (CIMPASI 1, CIMPASI 2, and CIMPACT) and psoriatic arthritis (Rapid-PsA). The represented data demonstrate high efficacy of certolizumab pegol is bio-naïve patients and in patients previously exposed to other TNF inhibitors or IL17 inhibitors. The absence of the Fc-fragment in certolizumab pegol ensures minimal to no placental transfer of the drug and enables its usage during the entire pregnancy.

Conflict of interest: the authors state that there is no potential conflict of interest requiring disclosure in this article.

About the authors

A. A. Kubanov

State Research Center of Dermatovenereology and Cosmetology, Ministry of Health of the Russian Federation

Email: fake@neicon.ru
Alexey A. Kubanov — Dr. Sci. (Med.), Prof., Corresponding Member of Russian Academy of Sciences, Acting Director Россия

A. L. Bakulev

Saratov State Medical University named after V. I. Razumovsky, Ministry of Health of the Russian Federation

Email: fake@neicon.ru
Andrey L. Bakulev — Dr. Sci. (Med)., Prof., Head of the Department of Dermatovenerology and Cosmetology Россия

M. I. Gluzmin

Kuban State Medical University, Ministry of Health of the Russian Federation

Email: fake@neicon.ru
Mikhail I. Gluzmin — Cand. Sci. (Med)., Assoc. Prof., Department Россия

M. M. Kokhan

Ural Research Institute for Dermatovenerology and Immunopatology

Email: fake@neicon.ru
Muza M. Kokhan — Dr. Sci. (Med.), Prof., Head of the Research Clinical Dermatology Department Россия

L. S. Kruglova

Central State Medical Academy, Administrative Department of the President of the Russian Federation

Email: fake@neicon.ru
Larisa S. Kruglova — Dr. Sci. (Med.), Prof., Head of the Department of Dermatovenereology and Cosmetology Россия

N. S. Rudneva

Tula Regional Clinical Dermatovenerologic Dispensar

Email: fake@neicon.ru

Natalia S. Rudneva — Cand. Sci. (Med.), Chief Physician

Chief Specialist, Dermatovenerologist, Cosmetologist, Ministry of Health of the Tula Region

Россия

O. Yu. Olisova

I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation

Author for correspondence.
Email: olisovaolga@mail.ru
Olga Yu. Olisova — Dr. Sci. (Med.), Prof., Departmental Head Россия

E. V. Sokolovsky

Pavlov First Saint Petersburg State Medical University, Ministry of Health of the Russian Federation

Email: fake@neicon.ru
Evgeny V. Sokolovsky – Dr. Sci. (Med.), Prof., Head of the Department of Dermatovenereology Россия

M. M. Khobeish

Pavlov First Saint Petersburg State Medical University, Ministry of Health of the Russian Federation

Email: fake@neicon.ru
Marianna M. Khobeish – Cand. Sci. (Med.), Assoc. Prof., Department of Dermatovenereology Россия

References

  1. Greb J. et al. Psoriasis. Nat Rev Dis Primers. 2016;2:16082. doi: 10.1038/nrdp.2016.82
  2. Rendon A., Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019;20:1475.
  3. Mease P. J., Armstrong A. W. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74(4):423–441.
  4. Gladman D. D., Antoni C., Mease P., Clegg D. O., Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64 (Suppl 2):ii14–ii17. doi: 10.1136/ard.2004.032482
  5. Leung Y. Y., Tam L. S., Kun E. W., Li E. K. Psoriatic arthritis as a distinct disease entity. J Postgrad Med. 2007;53:63–71.
  6. Tsuruta N. et al. Cross-sectional multicenter observational study of psoriatic arthritis in Japanese patients: Relationship between skin and joint symptoms and results of treatment with tumor necrosis factor-α inhibitors. J Dermatol. 2019;46(3):193–198.
  7. Ritchlin et al. Psoriatic Arthritis. N Engl J Med. 2017;376:957–970.
  8. Scher et al. Preventing psoriatic arthritis: focusing on patients with psoriasis at increased risk of transition. Nature Reviews Rheumatology. 2019;15:153–166.
  9. Carron P. et al. Scintigraphic Detection of TNFα with a Radiolabeled Anti-TNFα in Patients with Active Peripheral Spondyloarthritis and Rheumatoid Arthritis. Arthritis and Rheumatism. 2013;65(10):1113.
  10. Nesbitt et al. Mechanism of action of certolizumab pegol (CDP870): In vitro comparison with other anti-tumor necrosis factor α agents. Infl Bowel Dis. 2007;13(11):1323–1332.
  11. Cassinotti A.., Ardizzone S., Porro G B. Certolizumab pegol: an evidence-based review of its place in the treatment of Crohn’s disease. Core Evid. 2008;2(3):209–229.
  12. Tracey et al. Tumor necrosis factor antagonist mechanisms of action: A comprehensive review. Pharmacology & Therapeutics 2008;117(2):244–279.
  13. Mariette X., Förger F., Abraham B. et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77(2):228– 233. doi: 10.1136/annrheumdis-2017–212196
  14. Gottlieb AB et al. Certolizumab pegol for the treatment of patients with moderate-to-severe chronic plaque psoriasis: pooled analysis of week 16 data from three randomized controlled trials. J Am Acad Dermatol. 2018;79(2):302–314.
  15. Lebwohl et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Derm. 2018;79(2):266–276.e5.
  16. Gottlieb A. B. et al. Durable reduction in absolute PASI with certolizumab pegol in patients with chronic plaque psoriasis. Acta Dermatovenerologica. 2018;98(S219):P053.
  17. Reich K. et al. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab′ certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012;167(1):180–190.
  18. Gottlieb AB et al. Nail outcome improvements with certolizumab pegol in moderate to severe plaque psoriasis: results from phase 3 trials. JEADV. 2019;33(S3):P116. https://onlinelibrary.wiley.com/doi/full/10.1111/jdv.15514#
  19. Blauvelt et al. Certolizumab Pegol Is Effective for Chronic Plaque Psoriasis Regardless of Previous Exposure to Systemic Therapy: A Pooled Subanalysis of Ongoing, Phase 3 Studies (CIMPASI-1, CIMPASI-2, CIMPACT). AAD2018 Poster 7774. https://www.aad.org/eposters/view/ Abstract.aspx?id=7774
  20. Mease P. J. et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73(1):48–55.
  21. van der Heijde D. et al. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018;4:e000582. doi: 10.1136/rmdopen-2017-000582
  22. Blauvelt A. et al. Safety of certolizumab pegol in plaque psoriasis: pooled 96-week data from three phase 3, multicenter, randomized, placebo-controlled studies (CIMPASI-1, CIMPASI-2 and CIMPACT). JEADV 2019;33(Suppl 3):20–44. P032.
  23. Murase J. E., Chan K. K., Garite T. J., Cooper D. M., Weinstein G. D. Hormonal effect on psoriasis in pregnancy and post partum. Arch Dermatol. 2005;141:601–606.
  24. Gottlieb A. B., Ryan C., Murase J. E. Clinical considerations for the management of psoriasis in women. Int J Womens Dermatol. 2019;5(3):141–150.
  25. Bröms G., Haerskjold A., Granath F., Kieler H., Pedersen L., Berglind I. A. Effect of maternal psoriasis on pregnancy and birth outcomes: A population-based cohort study from Denmark and Sweden. Acta Derm Venereol. 2018;98(8):728–734.
  26. Hazes J. M., Coulie P. G., Geenen V. et al. Rheumatoid arthritis and pregnancy: evolution of disease activity and pathophysiological considerations for drug use. Rheumatology (Oxford). 2011;50(11):1955–1968. doi: 10.1093/rheumatology/ker302
  27. Malek A. et al. Evolution of maternofetal transport of immunoglobulins during human pregnancy. Am J Repr lmm. 1996;36:248–255.
  28. Roopenian D. S., Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nat Rev Imm. 2007;7:715–725.
  29. Mahadevan U et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013;11(3):286–292.
  30. Clowse M. E. B. et al. Characteristics and outcomes of prospectively reported pregnancies exposed to certolizumab pegol from a safety database. Ann Rheum Dis. 2018;77(Suppl):A149.
  31. Clowse M. E. B., Förger F., Hwang C. et al. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017;76:1890–1896.

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Copyright (c) 2019 Kubanov A.A., Bakulev A.L., Gluzmin M.I., Kokhan M.M., Kruglova L.S., Rudneva N.S., Olisova O.Y., Sokolovsky E.V., Khobeish M.M.

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