A Real-Life 208 Week Single-Centred, Register-Based Retrospective Study Assessing Secukinumab Survival and Long-Term Efficacy and Safety Among Greek Patients With Moderate to Severe Plaque Psoriasis, Including Difficult-to-Treat Manifestations Such as Genitals and Scalp

A Real-Life 208 Week Single-Centred, Register-Based Retrospective Study Assessing Secukinumab Survival and Long-Term Efficacy and Safety Among Greek Patients With Moderate to Severe Plaque Psoriasis, Including Difficult-to-Treat Manifestations Such as Genitals and Scalp

Authors

  • Eirini Kyrmanidou Second Department of Dermatology, Medical School, Aristotle University of Thessaloniki, Greece
  • Christina Kemanetzi Second Department of Dermatology, Medical School, Aristotle University of Thessaloniki, Greece
  • Chatzopoulos Stavros School of Statistics and Insurance Science, University of Western Macedonia, Kozani, Greece
  • Myrto-Georgia Trakatelli Second Department of Dermatology, Medical School, Aristotle University of Thessaloniki, Greece
  • Aikaterini Patsatsi Second Department of Dermatology, Medical School, Aristotle University of Thessaloniki, Greece
  • Xenia Madia Novartis, Greece
  • Dimitra Ignatiadi Novartis, Greece
  • Evangelia Kalloniati Second Department of Dermatology, Medical School, Aristotle University of Thessaloniki, Greece
  • Zoe Apalla Second Department of Dermatology, Medical School, Aristotle University of Thessaloniki, Greece
  • Elizabeth Lazaridou Second Department of Dermatology, Medical School, Aristotle University of Thessaloniki, Greece

Keywords:

psoriasis, genital psoriasis, scalp psoriasis, secukinumab, Greece

Abstract

Introduction: Psoriasis is a chronic inflammatory disease with multiple skin manifestations, and in case of lesions affecting the genital area sexual health impairment and psychological distress can furthermore impair the quality of life of patients. Secukinumab is a fully humanized antagonist of IL-17A and is indicated for the treatment of moderate-to-severe psoriasis.

Objectives: This study was conducted in order to gather retrospective real-world data regarding the efficacy of secukinumab in treating patients with moderate-to-severe plaque psoriasis in Greece. We included difficult-to-treat manifestations in our analysis, specifically regarding the efficacy in the genital area and on the skin folds.

Methods: All adult patients receiving 300 mg of secukinumab and attending follow-up visits on a regular basis, according to routine medical practice, were included. The timeline of the study was from 2015 to 2020. Primary endpoint of the study was the percentage of patients who achieved a PASI75 response rate at week 16 and week 52 post baseline. 

Results: Ninety-nine patients were included in the study population. Regarding difficult-to-treat manifestations, we recorded scalp involvement in 74.74% (74/99) of our patients, genital psoriasis in 27.27% (27/99), and skin fold involvement (psoriasis inversa) in 17% (17/99). At week 16, PASI75/PASI90/PASI100 were observed in 87.5%/69.8%/49%, respectively. Treatment with secukinumab during the 208 weeks of observation did not reveal any major adverse event.

Conclusion: According to our outcomes, secukinumab is an effective treatment choice for treating chronic plaque psoriasis, but additionally it can be efficacious in the subgroups of patients with difficult-to-treat manifestations. 

References

Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. Journal of the American Academy of Dermatology. 2014/03 2014;70(3):512-516. doi:10.1016/j.jaad.2013.11.013

Dopytalska K, Sobolewski P, Błaszczak A, Szymańska E, Walecka I. Psoriasis in special localizations. Reumatologia. 2018;56(6):392-398. doi:10.5114/reum.2018.80718

Hong JJ, Mosca ML, Hadeler EK, Brownstone ND, Bhutani T, Liao WJ. Genital and Inverse/Intertriginous Psoriasis: An Updated Review of Therapies and Recommendations for Practical Management. Dermatology and therapy. 2021;11(3):833-844. doi:10.1007/s13555-021-00536-6

Blauvelt A, Prinz JC, Gottlieb AB, et al. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). British Journal of Dermatology. 2014/12/11 2014;172(2):484-493. doi:10.1111/bjd.13348

Secukinumab efficacy and safety in Asian subjects with moderate to severe plaque psoriasis: Pooled analysis from the FIXTURE and ERASURE phase III clinical studies. Journal of the American Academy of Dermatology. 2015/05 2015;72(5):AB249. doi:10.1016/j.jaad.2015.02.994

Rompoti N, Katsimbri P, Kokkalis G, et al. Real world data from the use of secukinumab in the treatment of moderate‐to‐severe psoriasis, including scalp and palmoplantar psoriasis: A 104‐week clinical study. Dermatologic Therapy. 2019/07/15 2019;32(5)doi:10.1111/dth.13006

Bai F, Li GG, Liu Q, Niu X, Li R, Ma H. Short-Term Efficacy and Safety of IL-17, IL-12/23, and IL-23 Inhibitors Brodalumab, Secukinumab, Ixekizumab, Ustekinumab, Guselkumab, Tildrakizumab, and Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Journal of immunology research. 2019;2019:2546161-2546161. doi:10.1155/2019/2546161

Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). Journal of the European Academy of Dermatology and Venereology : JEADV. 2018;32(9):1507-1514. doi:10.1111/jdv.14878

Langley RG, Sofen H, Dei-Cas I, et al. Secukinumab long-term efficacy and safety in psoriasis through to year 5 of treatment: results of a randomized extension of the phase III ERASURE and FIXTURE trials. British Journal of Dermatology. 2022/10/21 2022;188(2):198-207. doi:10.1093/bjd/ljac040

Augustin M, von Kiedrowski R, Rigopoulos D. 33596 Secukinumab demonstrated sustained retention and safety in a real-world setting in patients with moderate to severe plaque psoriasis: Long-term results from an interim analysis of the SERENA study. Journal of the American Academy of Dermatology. 2022/09 2022;87(3):AB107. doi:10.1016/j.jaad.2022.06.462

Bagel J, Duffin KC, Moore A, et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. Journal of the American Academy of Dermatology. 2017/10 2017;77(4):667-674. doi:10.1016/j.jaad.2017.05.033

Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatology and therapy. 2016;6(4):627-638. doi:10.1007/s13555-016-0139-0

Kivelevitch D, Amin S, Menter A. Clinical utility of secukinumab in moderate-to-severe scalp psoriasis: evidence to date. Clinical, cosmetic and investigational dermatology. 2019;12:249-253. doi:10.2147/CCID.S165040

Reich K, Sullivan J, Arenberger P, et al. Secukinumab shows high and sustained efficacy in nail psoriasis: 2.5‐year results from the randomized placebo‐controlled TRANSFIGURE study*. British Journal of Dermatology. 2020/12/16 2020;184(3):425-436. doi:10.1111/bjd.19262

Gottlieb AB, Kubanov A, Doorn M, et al. Sustained efficacy of secukinumab in patients with moderate‐to‐severe palmoplantar psoriasis: 2·5‐year results from GESTURE , a randomized, double‐blind, placebo‐controlled trial. British Journal of Dermatology. 2019/12/15 2019;182(4):889-899. doi:10.1111/bjd.18331

Burlando M, Herzum A, Carmisciano L, Cozzani E, Parodi A. Biological therapy in genital psoriasis in women. Dermatologic Therapy. 2019/12/04 2019;33(1)doi:10.1111/dth.13110

Mendes‐Bastos P, Morais P, Ferreira P, et al. Persistence, effectiveness, and real‐world outcomes in psoriasis patients treated with secukinumab in Portugal. Dermatologic Therapy. 2022/05/10 2022;35(7)doi:10.1111/dth.15510

Yiu ZZN, Mason KJ, Hampton PJ, et al. Drug survival of adalimumab, ustekinumab and secukinumab in patients with psoriasis: a prospective cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). British Journal of Dermatology. 2020/03/30 2020;183(2):294-302. doi:10.1111/bjd.18981

Secukinumab, Summary of Product Characteristics, Date of last revision: 10 July 2023.

Mehta P, Lawrence A, Aggarwal A. Paradoxical gastrointestinal effects of interleukin-17 blockers. Annals of the Rheumatic Diseases. 2020/09/28 2020:annrheumdis-2020-218719. doi:10.1136/annrheumdis-2020-218719

Downloads

Published

2024-04-30

How to Cite

1.
A Real-Life 208 Week Single-Centred, Register-Based Retrospective Study Assessing Secukinumab Survival and Long-Term Efficacy and Safety Among Greek Patients With Moderate to Severe Plaque Psoriasis, Including Difficult-to-Treat Manifestations Such as Genitals and Scalp. Dermatol Pract Concept [Internet]. 2024 Apr. 30 [cited 2024 Sep. 10];14(2):e2024119. Available from: https://dpcj.org/index.php/dpc/article/view/3895

Share