Drug Survival of IL-12/23, IL-17 and IL-23 Inhibitors for Psoriasis Treatment: A Retrospective Multi-Country, Multicentric Cohort Study
Jazyk angličtina Země Nový Zéland Médium print-electronic
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie
PubMed
33786754
DOI
10.1007/s40257-021-00598-4
PII: 10.1007/s40257-021-00598-4
Knihovny.cz E-zdroje
- MeSH
- biologické přípravky farmakologie terapeutické užití MeSH
- časové faktory MeSH
- dermatologické látky farmakologie terapeutické užití MeSH
- dospělí MeSH
- indukce remise metody MeSH
- interleukin-12 antagonisté a inhibitory imunologie MeSH
- interleukin-17 antagonisté a inhibitory imunologie MeSH
- interleukin-23 antagonisté a inhibitory imunologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- psoriáza farmakoterapie imunologie MeSH
- retrospektivní studie MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- srovnávací studie MeSH
- Názvy látek
- biologické přípravky MeSH
- dermatologické látky MeSH
- interleukin-12 MeSH
- interleukin-17 MeSH
- interleukin-23 MeSH
BACKGROUND: Drug survival analysis of biologic agents in psoriasis is of extreme importance, as it allows not only the evaluation of objective clinical outcomes (such as effectiveness and safety) but also of factors that are associated with patients' adherence to treatment. The aim of this study was to evaluate and compare the drug survival of the most recent biologic agents approved for the treatment of moderate-to-severe psoriasis-ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, and risankizumab-and to identify clinical predictors that can influence the drug survival of these drugs. METHODS: This retrospective multicentric cohort study from 16 dermatology centers in Portugal, Spain, Italy, Switzerland, Czech Republic, Canada, and the United States included patients that started IL-12/23, IL-17 (IL-17A and IL-17R) and IL-23 inhibitors for the treatment of psoriasis between January 1, 2012 and December 31, 2019. Survival analysis was performed using a Kaplan-Meier estimator, to obtain descriptive survival curves, and proportional hazard Cox regression models. RESULTS: A total of 3312 treatment courses (total patients: 3145) were included in the study; 1118 (33.8%) with an IL-12/23 inhibitor (ustekinumab), 1678 (50.7%) with an IL-17 inhibitor [911 (27.5%) on secukinumab, 651 (19.7%) on ixekizumab, 116 (3.5%) on brodalumab], and 516 (15.5%) with an IL-23 inhibitor [398 (12.0%) on guselkumab, 118 (3.5%) on risankizumab]. At 18 months, the cumulative probability of survival was 96.4% for risankizumab, 91.1% for guselkumab, 86.3% for brodalumab, 86.1% for ustekinumab, 82.0% for ixekizumab, and 79.9% for secukinumab. Using ustekinumab as reference, drug survival of guselkumab was higher (HR 0.609; 95% CI 0.418-0.887) and that of secukinumab was lower (HR 1.490; 95% CI 1.257-1.766). In the final multivariable model, secukinumab, female sex, higher BMI, and prior exposure to biologic agents significantly increased the risk of drug discontinuation, whereas risankizumab was protective. CONCLUSION: In this multinational cohort with 8439 patient-years of follow-up, the cumulative probability of drug survival for all drugs was >79% at 18 months. Prescribed biologic, female sex, higher BMI, and previous exposure to biologic agents were predictors of drug discontinuation. Drug survival of guselkumab and risankizumab was higher than that of ustekinumab, and secukinumab was lower.
Center for Health Technology and Services Research Porto Portugal
Clínica Médica Belém Lisbon Portugal
Department of Dermatology Centro Hospitalar Universitário do Porto Porto Portugal
Department of Dermatology Germans Trias i Pujol University Hospital Badalona Spain
Department of Dermatology Hospital de la Santa Creu i Sant Pau Barcelona Spain
Department of Dermatology University of Pisa Pisa Italy
Dermatology Unit Department of Medicine University of Padua 35128 Padua Italy
Fondazione Policlinico Universitario A Gemelli IRCCS Rome Italy
Hospital CUF Descobertas Lisbon Portugal
Instituto de Ciências Biomédicas Abel Salazar University of Porto Porto Portugal
Lynde Institute for Dermatology Markham Ontario Canada
McMaster University Hamilton Ontario Canada
Michael G DeGroote School of Medicine Faculty of Medicine Hamilton Ontario Canada
Università Cattolica del Sacro Cuore Largo Agostino Gemelli 8 00168 Rome Italy
Zobrazit více v PubMed
Langley RGB, Krueger GG, Griffiths CEM. Psoriasis: Epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64:ii18–23 (discussion ii24–5).
Rendon A, Schäkel K. Psoriasis pathogenesis and treatment. Int J Mol Sci. 2019;20:1475. DOI
Hu Y, Chen Z, Gong Y, Shi Y. A review of switching biologic agents in the treatment of moderate-to-severe plaque psoriasis. Clin Drug Investig. 2018;38:191–9. DOI
Costanzo A, Malara G, Pelucchi C, Fatiga F, Barbera G, Franchi A, et al. Effectiveness end points in real-world studies on biological therapies in psoriasis: systematic review with focus on drug survival. Dermatology. 2018;234:1–12. DOI
van den Reek JMPA, Kievit W, de Jong EMGJ. Comment on “Drug survival analysis is not a good method for assessing the safety or effectiveness of systemic therapies in psoriasis.” Actas Dermosifiliogr. 2017;108:695–6. DOI
van den Reek JMPA, Kievit W, Gniadecki R, Goeman JJ, Zweegers J, van de Kerkhof PCM, et al. Drug survival studies in dermatology: principles, purposes, and pitfalls. J Invest Dermatol. 2015;135:1–5. DOI
Pogácsás L, Borsi A, Takács P, Remenyik É, Kemény L, Kárpáti S, et al. Long-term drug survival and predictor analysis of the whole psoriatic patient population on biological therapy in Hungary. J Dermatol Treat. 2017;28:635–41. DOI
Mason KJ, Barker JNWN, Smith CH, Hampton PJ, Lunt M, McElhone K, et al. Comparison of drug discontinuation, effectiveness, and safety between clinical trial eligible and ineligible patients in BADBIR. JAMA Dermatol. 2018;154:581–8. DOI
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. DOI
Mourad A, Straube S, Armijo-Olivo S, Gniadecki R. Factors predicting persistence of biologic drugs in psoriasis: a systematic review and meta-analysis. Br J Dermatol. 2019;181:450–8. DOI
Yiu ZZN, Mason KJ, Hampton PJ, Reynolds NJ, Smith CH, Lunt M, 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). Br J Dermatol. 2020;183:294–302. DOI
Egeberg A, Bryld LE, Skov L. Drug survival of secukinumab and ixekizumab for moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2019;81:173–8. DOI
Shalom G, Cohen AD, Feldhamer I, Comaneshter D, Freud T, Pavlovsky L. Drug survival in patients with psoriasis is associated with the availability of biologic medications. J Eur Acad Dermatol Venereol. 2020;34:1524–8. DOI
Egeberg A, Ottosen MB, Gniadecki R, Broesby-Olsen S, Dam TN, Bryld LE, et al. Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis. Br J Dermatol. 2018;178:509–19. DOI
Menter A, Papp KA, Gooderham M, Pariser DM, Augustin M, Kerdel FA, et al. Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Eur Acad Dermatol Venereol. 2016;30:1148–58. DOI
Lin P-T, Wang S-H, Chi C-C. Drug survival of biologics in treating psoriasis: a meta-analysis of real-world evidence. Sci Rep. 2018;8:16068. DOI
Warren RB, Blauvelt A, Poulin Y, Beeck S, Kelly M, Wu T, et al. Efficacy and safety of risankizumab vs. secukinumab in patients with moderate‐to‐severe plaque psoriasis (IMMerge): results from a phase III, randomized, open‐label, efficacy–assessor‐blinded clinical trial. Br J Dermatol. 2020. https://doi.org/10.1111/bjd.19341
Reich K, Armstrong AW, Langley RG, Flavin S, Randazzo B, Li S, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;394:831–9. DOI
López-Sánchez C, Puig L. Guselkumab in the treatment of moderate-to-severe plaque psoriasis. Immunotherapy. 2020;12:355–71. DOI
Mehta H, Mashiko S, Angsana J, Rubio M, Hsieh YM, Maari C, et al. Differential changes in inflammatory mononuclear phagocyte and T cell profiles within psoriatic skin during treatment with guselkumab versus secukinumab. J Invest Dermatol. 2021. https://doi.org/10.1016/j.jid.2021.01.005 . PubMed DOI
Nedoszytko B, Lange M, Sokolowska-Wojdylo M, Renke J, Trzonkowski P, Sobjanek M, et al. The role of regulatory T cells and genes involved in their differentiation in pathogenesis of selected inflammatory and neoplastic skin diseases. Part II: The Treg role in skin diseases pathogenesis. Postepy Dermatol Alergol. 2017;34:405–17.
Laws PM, Downs AM, Parslew R, Dever B, Smith CH, Barker JN, et al. Practical experience of ustekinumab in the treatment of psoriasis: Experience from a multicentre, retrospective case cohort study across the U.K. and Ireland. Br J Dermatol. 2012;166:189–95.
Lunder T, Zorko MS, Kolar NK, Suhodolcan AB, Marovt M, Leskovec NK, et al. Drug survival of biological therapy is showing class effect: updated results from Slovenian National Registry of psoriasis. Int J Dermatol. 2019;58:631–41. DOI
Graier T, Salmhofer W, Jonak C, Weger W, Kölli C, Gruber B, et al. Biologic drug survival rates in the era of anti-Il-17 antibodies: a time period-adjusted registry analysis. Br J Dermatol. 2020. https://doi.org/10.1111/bjd.19701 . PubMed DOI
Torres T, Balato A, Conrad C, Conti A, Dapavo P, Ferreira P, et al. Secukinumab drug survival in patients with psoriasis: a multicenter, real-world, retrospective study. J Am Acad Dermatol. 2019;81:273–5. DOI
van der Schoot LS, van den Reek JMPA, Groenewoud JMM, Otero ME, Njoo MD, Ossenkoppele PM, et al. Female patients are less satisfied with biological treatment for psoriasis and experience more side-effects than male patients: results from the prospective BioCAPTURE registry. J Eur Acad Dermatol Venereol. 2019;33:1913–20. DOI
Carrascosa JM, Vilavella M, Garcia-Doval I, Carretero G, Vanaclocha F, Daudén E, et al. Body mass index in patients with moderate-to-severe psoriasis in Spain and its impact as an independent risk factor for therapy withdrawal: results of the Biobadaderm Registry. J Eur Acad Dermatol Venereol. 2014;28:907–14. DOI
Schwensen JFB, Nielsen VW, Nissen CV, Sand C, Gniadecki R, Thomsen SF. Effectiveness and safety of guselkumab in 50 patients with moderate to severe plaque psoriasis who had previously been treated with other biologics: a retrospective real-world evidence study. J Eur Acad Dermatology Venereol. 2020. https://doi.org/10.1111/jdv.17092 . DOI
Mease PJ, Kellner H, Morita A, Kivitz AJ, Papp KA, Aslanyan S, et al. OP0307 Efficacy and safety of risankizumab, a selective il-23p19 inhibitor, in patients with active psoriatic arthritis over 24 weeks: results from a phase 2 trial. Ann Rheum Dis. 2018;77:200–1.
Deodhar A, Gottlieb AB, Boehncke WH, Dong B, Wang Y, Zhuang Y, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2018;391:2213–24. DOI
Mease PJ, Rahman P, Gottlieb AB, Kollmeier AP, Hsia EC, Xu XL, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395:1126–36. DOI