The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study

KUNDAKCI, NİHAL; Aygün Alizada, Merve; Kalay Yıldızhan, İncilay

doi:10.4274/turkderm.galenos.2021.70446

The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study

İncilay Kalay Yıldızhan, (Ankara University Faculty of Medicine, Department of Dermatology, Ankara, Türkiye)

Merve Aygün, (Ankara University Faculty of Medicine, Department of Dermatology, Ankara,Türkiye)

Nihal Kundakçı (Ankara University Faculty of Medicine, Department of Dermatology, Ankara, Türkiye)

Türkderm Türk deri hastalıkları ve frengi arşivi

5 1

Yıl: 2021 Cilt: 55 Sayı: 3 Sayfa Aralığı: 113 - 118 Metin Dili: Türkçe DOI: 10.4274/turkderm.galenos.2021.70446 İndeks Tarihi: 21-05-2022

The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study

Öz:

Background and Design: Secukinumab is an effective treatment option in moderate-to-severe plaque type psoriasis. However, there are a few real-life data studies comparing the efficacy of 150 mg and 300 mg dosages. The aim of this study was to evaluate the efficacy and safety of secukinumab at 150 mg and 300 mg in clinical practice in chronic plaque type psoriasis patients attending our center. Materials and Methods: The medical records of 33 patients consecutively treated with secukinumab 150 mg or 300 mg for a minimum threemonth period were analyzed retrospectively. Treatment response was defined as the achievement of a minimum psoriasis area and severity index (PASI) 75 response at week 12. Results: Eighteen (55.5%) of the patients were men. The mean duration of the disease was 20±9.38 (1-40) years. Most (75.7%) patients had previously received at least one biological therapy. Seventeen patients were treated with 300 mg and 14 with 150 mg during the induction and maintenance periods. Two patients received induction therapy at 150 mg and maintenance therapy at 300 mg. At week 12, PASI 75, 90, and 100 responses were achieved in 78.8%, 66.7%, and 22.3% of patients, respectively. Treatment responses were similar between patients receiving 150 mg and 300 mg, and also between biologic naive and non-naive patients (p>0.05). Adverse events were observed in three patients, but these did not necessitate discontinuation of therapy. Conclusion: Secukinumab at doses of 150 mg and 300 mg is a fast-acting, effective and safe treatment option in patients with chronic plaque type psoriasis, both biologic naive and non-naive.

Anahtar Kelime:

Orta ve şiddetli plak tip psoriazis hastalarında sekukinumab (150 ve 300 mg) tedavisinin gerçek yaşam etkinliği ve güvenliği: On iki haftalık, tek merkezli, retrospektif bir çalışma

Öz:

Amaç: Sekukinumab orta ve şiddetli plak tip psoriaziste etkili bir tedavi seçeneğidir. Literatürde 150 mg ve 300 mg’nin etkinliğini karşılaştıran birkaç gerçek yaşam veri çalışması vardır. Bu çalışmanın amacı merkezimize başvuran kronik plak tip psoriazis hastalarında sekukinumab 150 mg ve 300 mg’nin klinik uygulamadaki etkinliğini ve güvenilirliğini değerlendirmektir. Gereç ve Yöntem: En az üç ay boyunca ardışık olarak sekukinumab 150 mg veya 300 mg ile tedavi edilen 33 hastanın tıbbi kayıtları retrospektif olarak incelendi. Tedavi yanıtı, 12. haftada minimum psoriazis alan ve şiddet indeksi (PAŞİ) 75 yanıtının elde edilmesi olarak tanımlandı. Bulgular: Hastaların 18’i (%55,5) erkekti. Hastalığın ortalama süresi 20±9,38 (1-40) yıl idi. Çoğu hasta (%75,7) daha önce en az bir biyolojik tedavi almıştı. İndüksiyon ve idame döneminde 17 hasta 300 mg, 14 hasta 150 mg ile tedavi edildi. İki hasta ise 150 mg ile indüksiyon tedavisi ve 300 mg ile idame tedavisi aldı. On ikinci haftada, hastaların %78,8, %66,7 ve %22,3’ünde sırasıyla PAŞİ 75, 90 ve 100 yanıtı elde edildi. Sekukinumab 150 mg ve 300 mg alan hastalar arasında ve biyolojik naif olan ve olmayan hastalar arasında tedavi yanıtları benzerdi (p>0,05). Üç hastada advers etkiler gözlendi ancak bunlar tedavinin kesilmesini gerektirmedi. Sonuç: Sekukinumab 150 mg ve 300 mg, hem biyolojik naif hem de naif olmayan kronik plak tip psoriazis hastalarında hızlı, etkili ve güvenli bir tedavi seçeneğidir.

Anahtar Kelime:

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık

1. Kurd SK, Gelfand JM: The prevalence of previously diagnosed and undiagnosed psoriasis in US adults: results from NHANES 2003-2004. J Am Acad Dermatol 2009;60:218-24.
2. Martin DA, Towne JE, Kricorian G, et al: The emerging role of IL-17 in the pathogenesis of psoriasis: preclinical and clinical findings. J Invest Dermatol 2013;133:17-26.
3. Sanford M, McKeage K: Secukinumab: first global approval. Drugs 2015;75:329-38.
4. Langley RG, Elewski BE, Lebwohl M, et al: ERASURE Study Group; Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med 2014;371:326-38.
5. McInnes IB, Mease PJ, Kirkham B, et al: Secukinumab, a human antiinterleukin- 17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015;386:1137-46.
6. van de Kerkhof PC, Griffiths CE, Reich K, et al: Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol 2016;75:83- 98.e4.
7. Baeten D, Baraliakos X, Braun J, et al: Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial. Lancet 2013;382:1705-13.
8. Augustin M, Jullien D, Martin A, Peralta C: Real-world evidence of secukinumab in psoriasis treatment - a meta-analysis of 43 studies. J Eur Acad Dermatol Venereol 2020;34:1174-85.
9. Thaci D, Blauvelt A, Reich K, et al: Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol 2015;73:400-9.
10. 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). Br J Dermatol 2015;172:484-93.
11. Lacour JP, Paul C, Jazayeri S, et al: Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial. J Eur Acad Dermatol Venereol 2017;31:847-56.
12. Mrowietz U, Leonardi CL, Girolomoni G, et al: SCULPTURE Study Group. Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: A randomized, doubleblind, noninferiority trial (SCULPTURE). J Am Acad Dermatol 2015;73:27-36. e21.
13. Notario J, Deza G, Vilarrasa E, et al: Treatment of patients with plaque psoriasis with secukinumab in a real-life setting: a 52-week, multicenter, retrospective study in Spain. J Dermatolog Treat 2019;30:424-9.
14. Schwensen JF, Clemmensen A, Sand C, et al: Effectiveness and safety of secukinumab in 69 patients with moderate to severe plaque psoriasis: A retrospective multicenter study. Dermatol Ther 2017;30.
15. Ger TY, Huang YH, Hui RC, Tsai TF, Chiu HY: Effectiveness and safety of secukinumab for psoriasis in real-world practice: analysis of subgroups stratified by prior biologic failure or reimbursement. Ther Adv Chronic Dis 2019;10:2040622319843756.
16. Blauvelt A, Reich K, Tsai TF, et al: Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol 2017;76:60-9.
17. 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. Dermatol Ther 2019;32:e13006.
18. Huang YYM, Ruth JS, Hsu S: Loss of efficacy of secukinumab for psoriasis at 24 to 32 weeks. J Am Acad Dermatol 2016;75:e169.
19. Galluzzo M, Talamonti M, De Simone C, et al: Secukinumab in moderate-tosevere plaque psoriasis: a multi-center, retrospective, real-life study up to 52 weeks observation. Expert Opin Biol Ther 2018;18:727-35.
20. Leman J, Burden AD: Sequential use of biologics in the treatment of moderate-to-severe plaque psoriasis. Br J Dermatol 2012;167(Suppl3):12-20.
21. Megna M, Di Costanzo L, Argenziano G, et al: Effectiveness and safety of secukinumab in Italian patients with psoriasis: an 84 week, multicenter, retrospective real-world study. Expert Opin Biol Ther 2019;19:855-61.
22. Chiricozzi A, Balato A, Conrad C, et al: Secukinumab demonstrates improvements in absolute and relative psoriasis area severity indices in moderate-to-severe plaque psoriasis: results from a European, multicentric, retrospective, real-world study. J Dermatolog Treat 2020;31:476-83.
23. Bissonnette R, Luger T, Thaci D, et al: Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderateto- severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol 2018;32:1507-14.
24. Blauvelt A: Safety of secukinumab in the treatment of psoriasis. Expert Opin Drug Saf 2016;15:1413-20.
25. Deodhar A, Mease PJ, McInnes IB, et al: Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data. Arthritis Res Ther 2019;21:111.

APA	Kalay Yıldızhan İ, Aygün Alizada M, KUNDAKCI N (2021). The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study. , 113 - 118. 10.4274/turkderm.galenos.2021.70446
Chicago	Kalay Yıldızhan İncilay,Aygün Alizada Merve,KUNDAKCI NİHAL The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study. (2021): 113 - 118. 10.4274/turkderm.galenos.2021.70446
MLA	Kalay Yıldızhan İncilay,Aygün Alizada Merve,KUNDAKCI NİHAL The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study. , 2021, ss.113 - 118. 10.4274/turkderm.galenos.2021.70446
AMA	Kalay Yıldızhan İ,Aygün Alizada M,KUNDAKCI N The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study. . 2021; 113 - 118. 10.4274/turkderm.galenos.2021.70446
Vancouver	Kalay Yıldızhan İ,Aygün Alizada M,KUNDAKCI N The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study. . 2021; 113 - 118. 10.4274/turkderm.galenos.2021.70446
IEEE	Kalay Yıldızhan İ,Aygün Alizada M,KUNDAKCI N "The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study." , ss.113 - 118, 2021. 10.4274/turkderm.galenos.2021.70446
ISNAD	Kalay Yıldızhan, İncilay vd. "The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study". (2021), 113-118. https://doi.org/10.4274/turkderm.galenos.2021.70446

APA	Kalay Yıldızhan İ, Aygün Alizada M, KUNDAKCI N (2021). The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study. Türkderm Türk deri hastalıkları ve frengi arşivi, 55(3), 113 - 118. 10.4274/turkderm.galenos.2021.70446
Chicago	Kalay Yıldızhan İncilay,Aygün Alizada Merve,KUNDAKCI NİHAL The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study. Türkderm Türk deri hastalıkları ve frengi arşivi 55, no.3 (2021): 113 - 118. 10.4274/turkderm.galenos.2021.70446
MLA	Kalay Yıldızhan İncilay,Aygün Alizada Merve,KUNDAKCI NİHAL The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study. Türkderm Türk deri hastalıkları ve frengi arşivi, vol.55, no.3, 2021, ss.113 - 118. 10.4274/turkderm.galenos.2021.70446
AMA	Kalay Yıldızhan İ,Aygün Alizada M,KUNDAKCI N The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study. Türkderm Türk deri hastalıkları ve frengi arşivi. 2021; 55(3): 113 - 118. 10.4274/turkderm.galenos.2021.70446
Vancouver	Kalay Yıldızhan İ,Aygün Alizada M,KUNDAKCI N The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study. Türkderm Türk deri hastalıkları ve frengi arşivi. 2021; 55(3): 113 - 118. 10.4274/turkderm.galenos.2021.70446
IEEE	Kalay Yıldızhan İ,Aygün Alizada M,KUNDAKCI N "The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study." Türkderm Türk deri hastalıkları ve frengi arşivi, 55, ss.113 - 118, 2021. 10.4274/turkderm.galenos.2021.70446
ISNAD	Kalay Yıldızhan, İncilay vd. "The real-life efficacy and safety of secukinumab therapy (150 and 300 mg) in patients with moderate-to-severe plaque psoriasis: A twelve week, single center, retrospective study". Türkderm Türk deri hastalıkları ve frengi arşivi 55/3 (2021), 113-118. https://doi.org/10.4274/turkderm.galenos.2021.70446