Skip to main content

Advertisement

SpringerLink
Log in

A long-term, prospective, observational cohort study of the safety and effectiveness of etanercept for the treatment of patients with paediatric psoriasis in a naturalistic setting

  • Therapy
  • Published:
European Journal of Dermatology

Abstract

Background

Psoriasis is a chronic inflammatory skin disorder that affects 125 million people worldwide, with one-third having childhood onset.

Objectives

The PURPOSE study evaluated long-term safety and effectiveness of etanercept in paediatric psoriasis.

Materials & Methods

This observational study enrolled patients with paediatric psoriasis who were prescribed etanercept per routine care in eight EU countries. Patients were followed retrospectively (first dose prior to 30 days before enrolment) or prospectively (first dose within 30 days prior to or any time after enrolment) for five years. Safety endpoints included serious infections, opportunistic infections, malignancies, other serious adverse events (SAEs) and adverse events. Effectiveness endpoints (prospective patients) included treatment patterns, dose change/discontinuation, and physicians’ global subjective assessment of change in disease severity from baseline to follow-up.

Results

In total, 72 patients were enrolled (32 prospectively, 40 retrospectively), with mean age of 14.5 years and mean disease duration of 7.1 years. No serious or opportunistic infections/malignancies were reported. Psoriasis (n=8) and subcutaneous tissue disorders (system organ class) (erythema nodosum, erythrodermic psoriasis; n=1 for each) were the most frequently reported SAEs, which occurred in six (8.3%) patients with current/recent treatment and four (7.4%) with previous treatment. Of 25 treatment-emergent SAEs, seven (28.0%) were possibly related to etanercept. Assessments of prospective patients revealed that 28 (87.5%) completed 24 weeks, five (15.6%) required at least one subsequent course, and 93.8% experienced decreased disease severity. It is possible that some rare adverse events were not noted in this relatively small sample.

Conclusion

These real-world data are consistent with the known safety and efficacy profile of etanercept in paediatric patients with moderate to severe plaque psoriasis.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Dogra S, Mahajan R. Psoriasis: epidemiology, clinical features, co-morbidities, and clinical scoring. Indian Dermatol Online J 2016; 7: 471–80.

    Article  PubMed  PubMed Central  Google Scholar 

  2. World Health Organization. Global report on PSORIASIS. 2016. Available at: https://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf.psoriasis;jsessionid=54912784D28C-9F36ECCD45471AC5775B?sequence=1 [accessed 9 November 2020] [Epub ahead of print].

  3. National Psoariasis Foundation. Psoriasis statistics. 2020. Available at: https://www.psoriasis.org/psoriasis-statistics/ [accessed 9 November 2020] [Epub ahead of print].

  4. Pinson R, Sotoodian B, Fiorillo L. Psoriasis in children. Psoriasis (Auckl) 2016; 6: 121–9.

    PubMed  Google Scholar 

  5. Michalek IM, Loring B, John SM. A systematic review of worldwide epidemiology of psoriasis. J Eur Acad Dermatol Venereol 2017; 31: 205–12.

    Article  CAS  PubMed  Google Scholar 

  6. Megna M, Napolitano N, Balato A, et al. Psoriasis in children: A review. Curr Pediatr Rev 2015; 11: 10–26.

    Article  Google Scholar 

  7. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019; 80: 1029–72.

    Article  PubMed  Google Scholar 

  8. Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol 2020; 82: 161–201.

    Article  PubMed  Google Scholar 

  9. Curtis JR, Singh JA. Use of biologics in rheumatoid arthritis: current and emerging paradigms of care. Clin Ther 2011; 33: 679–707.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. Wilkinson N, Jackson G, Gardner-Medwin J. Biologic therapies for juvenile arthritis. Arch Dis Child 2003; 88: 186–91.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Lovell DJ, Reiff A, Jones OY, et al. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum 2006; 54: 1987–94.

    Article  PubMed  Google Scholar 

  12. Lovell DJ, Reiff A, Ilowite NT, et al. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthritis Rheum 2008; 58: 1496–504.

    Article  CAS  PubMed  Google Scholar 

  13. European Medicines Agency. Assessment report for Enbrel. 2011. Available at: https://www.ema.europa.eu/en/documents/variation-report/enbrel-h-c-262-ii-134-epar-assessment-report-variation_en.pdf [accessed 9 November 2020] [Epub ahead of print].

  14. European Medicines Agency. Committee for Medicinal Products for Human use (CHMP) summary of opinion (post authorisation) for Enbrel. 2011. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-enbrel_en-0.pdf [accessed 9 November 2020] [Epub ahead of print].

  15. European Medicines Agency. Committee for Medicinal Products for Human use (CHMP) Post-authorisation summary of positive opinion for Enbrel. 2008. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-enbrel-20-november-2008_en.pdf [accessed 9 November 2020] [Epub ahead of print].

  16. Connor V. Anti-TNF therapies: a comprehensive analysis of adverse effects associated with immunosuppression. Rheumatol Int 2011; 31: 327–37.

    Article  CAS  PubMed  Google Scholar 

  17. Prescribing information for Enbrel. Available at: https://www.pi.amgen.com/∼/media/amgen/repositorysites/pi-amgen-com/enbrel/enbrel_pi.pdf [accessed 9 November 2020] [Epub ahead of print].

  18. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section Sec6 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol 2011; 65: 137–74.

    Article  PubMed  Google Scholar 

  19. Paller AS, Siegfried EC, Pariser DM, et al. Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis. J Am Acad Dermatol 2016; 74: 280–7.e1–3.

    Article  CAS  PubMed  Google Scholar 

  20. Di Lernia V, Guarneri C, Stingeni L, et al. Effectiveness of etanercept in children with plaque psoriasis in real practice: a one-year multicenter retrospective study. J Dermatolog Treat 2018; 29: 217–9.

    Article  CAS  PubMed  Google Scholar 

  21. Paller AS, Siegfried EC, Langley RG, et al. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med 2008; 358: 241–51.

    Article  CAS  PubMed  Google Scholar 

  22. Constantin T, Foeldvari I, Vojinovic J, et al. Two-year efficacy and safety of etanercept in pediatric patients with extended oligoarthritis, enthesitis-related arthritis, or psoriatic arthritis. J Rheumatol 2016; 43: 816–24.

    Article  CAS  PubMed  Google Scholar 

  23. Thaçi D, Papp K, Marcoux D, et al. Sustained long-term efficacy and safety of adalimumab in paediatric patients with severe chronic plaque psoriasis from a randomized, double-blind, phase III study. Br J Dermatol 2019; 181: 1177–89.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Philipp S, Menter A, Nikkels AF, et al. Ustekinumab for the treatment of moderate-to-severe plaque psoriasis in paediatric 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: 664–72.

    Article  CAS  PubMed  Google Scholar 

  25. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol 2021; 35: 938–47.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  26. Paller AS, Seyger MMB, Alejandro Magariños G, et al. Efficacy and safety of ixekizumab in a phase III, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS). Br J Dermatol 2020; 183: 231–41.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  27. Bronckers I, Seyger MMB, West DP, et al. Safety of systemic agents for the treatment of pediatric psoriasis. JAMA Dermatol 2017; 153: 1147–57.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Leonardi C, Strober B, Gottlieb AB, et al. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. J Drugs Dermatol 2010; 9: 928–37.

    PubMed  Google Scholar 

Download references

Acknowledgments

The authors wish to thank Joel M. Gelfand, MD, for serving as a consultant for this study. Editorial support to prepare this manuscript for submission was provided by Lorna Forse, PhD, of Engage Scientific Solutions, and was funded by Pfizer.

Author information

Authors and Affiliations

  1. Global Medical Epidemiology, Pfizer Inc., 500 Arcola Road, Dock E, Collegeville, PA, 19426, USA

    Yun Gu

  2. Real-World Solutions, IQVIA, Emperor Boulevard, Durham, NC, 27703, USA

    Emma Brinkley, Joan Largent & Sara Colli

  3. Global Medical Epidemiology, Pfizer Inc., 235 E 42nd Street, New York, NY, 10017, USA

    Rachel E. Sobel

  4. Institute and Comprehensive Center for Inflammation Medicine, University of Luebeck, Ratzeburger Allee 160, 23538, Luebeck, Germany

    Diamant Thaçi

  5. Department of Dermatology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

    Marieke Seyger

  6. Department of Dermatology, Heim Pál Children’s Hospital, 1089, Budapest, Üllői út 86, Hungary

    Zsuzsanna Szalai

  7. Department of Dermatology, University of Nice Côte d’Azur, Nice, France

    Jean-Philippe Lacour

  8. Division of Dermatology, Department of Medicine, Karolinska Institutet, 17176, Stockholm, Sweden

    Mona Ståhle

Authors
  1. Yun Gu
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Emma Brinkley
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Joan Largent
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Rachel E. Sobel
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Sara Colli
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Diamant Thaçi
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Marieke Seyger
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Zsuzsanna Szalai
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Jean-Philippe Lacour
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Mona Ståhle
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yun Gu.

Additional information

Availability of data and material

Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-resultsfor more information.

Financial support

This study was funded by Pfizer, which was involved in study design, data collection, data analysis and manuscript preparation.

Conflicts of interest

Yun Gu is an employee and shareholder of Pfizer, one of the manufacturers of etanercept. Emma Brinkley, Sara Colli, and Joan Largent are employed by IQVIA, which received funding from Pfizer for the study and the development of the manuscript. Rachel E. Sobel was an employee of Pfizer at the time of the study and manuscript development and is a current shareholder of Pfizer, one of the manufacturers of etanercept. Diamant Thaçi reports personal fees as lecturer/consultant/scientific advisory board member from AbbVie, Almirall, Amgen, Asana Biosciences, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Janssen-Cilag, Kyowa Kirin, Leo Pharma, Eli Lilly, Novartis, Regeneron, Sandoz, Sanofi-Aventis, Pfizer, and UCB, and grants from AbbVie, Celgene, Leo Pharma, and Novartis, during the conduct of the study. Mona Ståhle has received grants from/was involved in clinical trials for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Leo Pharma, and Pfizer. She served as a consultant for AbbVie, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, and UCB; fees were paid directly to the institution. Zsuzsanna Szalai has no conflicts to declare. Jean-Philippe Lacour has received grants/research support as an investigator and honoraria, advisory board member or consulting fees from AbbVie, BMS, Boehringer Ingelheim, Celgene, Dermira, Galderma, Janssen, Eli Lilly and Company, Merck, Novartis, Regeneron, Roche, and Sanofi. Marieke Seyger has received grants from/was involved in clinical trials for AbbVie, Celgene, Eli Lilly, Janssen, Leo Pharma, and Pfizer, and served as a consultant for AbbVie, Eli Lilly, Janssen, Leo Pharma, and Pfizer.

IRB approval status

The protocol was reviewed and approved by the ethics committees within each participating country.

Clinical Trials.gov listing

NCT01100034

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Gu, Y., Brinkley, E., Largent, J. et al. A long-term, prospective, observational cohort study of the safety and effectiveness of etanercept for the treatment of patients with paediatric psoriasis in a naturalistic setting. Eur J Dermatol 33, 25–33 (2023). https://doi.org/10.1684/ejd.2023.4404

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1684/ejd.2023.4404

Key words

Search

Navigation