Real-life effectiveness and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: A 104-week multicenter retrospective study - IL PSO (ITALIAN LANDSCAPE PSORIASIS).

التفاصيل البيبلوغرافية
العنوان:	Real-life effectiveness and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: A 104-week multicenter retrospective study - IL PSO (ITALIAN LANDSCAPE PSORIASIS).
المؤلفون:	Gargiulo L; Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy.; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy., Ibba L; Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy.; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy., Malagoli P; Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy., Angileri RG; UOC Dermatologia, ARNAS Civico Di Palermo, Palermo, Italy., Bardazzi F; Dermatology Unit, Department of Specialistic, Diagnostic and Experimental Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy., Bernardini N; Dermatology Unit 'Daniele Innocenzi', Department of Medical-Surgical Sciences and Bio-Technologies, Sapienza University of Rome, Fiorini Hospital, Terracina, Italy., Burlando M; Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy., Carrera CG; Fondazione Cà Granda IRCCS Maggiore Policlinico Hospital, Milan, Italy., Chiricozzi A; Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.; Dermatologia, Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy., Dapavo P; Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy., Dini V; Dermatology Unit, Department of Clinical and Experimental Medicine Ospedale Santa Chiara, Pisa, Italy., Fabbrocini G; Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy., Gaiani FM; Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy., Galluzzo M; Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy., Giofré C; U.O.C. Dermatologia, A.O. Papardo, Messina, Italy., Guarneri C; Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy., Loconsole F; Department of Dermatology, University of Bari, Bari, Italy., Malara G; UOC of Dermatology, Great Metropolitan Hospital 'BMM', Reggio Calabria, Italy., Marcelli L; Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy., Megna M; Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy., Piaserico S; Dermatology Unit, Department of Medicine, University of Padova, Padua, Italy., Talamonti M; Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy., Costanzo A; Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy.; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy., Narcisi A; Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy.
المصدر:	Journal of the European Academy of Dermatology and Venereology : JEADV [J Eur Acad Dermatol Venereol] 2023 May; Vol. 37 (5), pp. 1017-1027. Date of Electronic Publication: 2023 Feb 08.
نوع المنشور:	Multicenter Study; Journal Article
اللغة:	English
بيانات الدورية:	Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 9216037 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1468-3083 (Electronic) Linking ISSN: 09269959 NLM ISO Abbreviation: J Eur Acad Dermatol Venereol Subsets: MEDLINE
أسماء مطبوعة:	Publication: Oxford : Wiley-Blackwell Original Publication: Amsterdam ; New York : Elsevier Science Publishers, c1992-
مواضيع طبية MeSH:	Ustekinumab/therapeutic use , Psoriasis/complications , Psoriasis*/drug therapy, Adult ; Humans ; Retrospective Studies ; Treatment Outcome ; Severity of Illness Index ; Antibodies, Monoclonal/adverse effects ; Double-Blind Method
مستخلص:	Background: Guselkumab is a fully human monoclonal antibody that binds selectively to the p19 subunit of interleukin-23, which has shown efficacy in patients with previous incomplete response to ustekinumab in the NAVIGATE clinical trial. [Correction added on [28-02-2023], after first online publication: 'humanized monoclonal antibody' has been changed to 'fully human monoclonal antibody' in the preceding sentence.] OBJECTIVES: We conducted a 104-week multicenter retrospective study to assess the effectiveness and safety of guselkumab in patients affected by plaque psoriasis with an inadequate response to ustekinumab in a real-life setting. Methods: Our retrospective study included 233 adults affected by moderate-to-severe plaque psoriasis, enrolled in 14 different Italian centres, and treated with guselkumab after failing therapy with ustekinumab. Patient characteristics and PASI (Psoriasis Area and Severity Index) score at each visit (baseline, weeks 16, 52 and 104) were recorded. The percentages of patients achieving 75%, 90% and 100% (PASI 75, PASI 90 and PASI 100) improvement in PASI, compared with baseline, were registered. Results: At week 52, PASI 75 was reached by 89.88% of patients, PASI 90 by 71.43%, PASI 100 by 58.83% and absolute PASI ≤2 by 90.48%. At week 104, similar effectiveness results were observed. Compared to the NAVIGATE trial, we observed higher rates of PASI 75/90/100. Patients with the involvement of difficult-to-treat areas were significantly less likely to achieve PASI90 and PASI100 at week 16. Obese patients had significantly lower rates of PASI75 and PASI ≤2 at week 52. At week 104, comparable responses were observed among all patients' subgroups, regardless of BMI status, involvement of difficult-to-treat areas, presence of cardiometabolic comorbidities and concomitant psoriatic arthritis. No significant safety findings were reported throughout the study. Conclusion: Our data suggest that the efficacy of guselkumab in patients with inadequate response to ustekinumab for plaque psoriasis in 'real-life' clinical practice is comparable with NAVIGATE study with higher percentages of patients achieving PASI90 and PASI100 at weeks 16, 52 and 104. (© 2023 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)
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المشرفين على المادة:	FU77B4U5Z0 (Ustekinumab) 089658A12D (guselkumab) 0 (Antibodies, Monoclonal)
تواريخ الأحداث:	Date Created: 20230125 Date Completed: 20230417 Latest Revision: 20230417
رمز التحديث:	20230417
DOI:	10.1111/jdv.18913
PMID:	36695061
قاعدة البيانات:	MEDLINE

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تدمد:	1468-3083
DOI:	10.1111/jdv.18913