Long-Term Drug Survival and Effectiveness of Secukinumab in Patients with Moderate to Severe Chronic Plaque Psoriasis: 42-Month Results from the SUPREME 2.0 Study.

Russo, Filomena; Galluzzo, Marco; Stingeni, Luca; Persechino, Severino; Zichichi, Leonardo; Conti, Andrea; Giofrè, Claudia; Dini, Valentina; Vispi, Martina; Atzori, Laura; Cattaneo, Angelo; Parodi, Aurora; Bardazzi, Federico; Stinco, Giuseppe; Dapavo, Paolo; Girolomoni, Giampiero; Musumeci, Maria Letizia; Papini, Manuela; Venturini, Marina; Dastoli, Stefano; Di Nuzzo, Sergio; Fargnoli, Maria Concetta; Pagnanelli, Gianluca; Bernardini, Nicoletta; Gambini, Daniele Mario; Malagoli, Piergiorgio; Mazzatenta, Carlo; Peris, Ketty; Zalaudek, Iris; Fabbrocini, Gabriella; Loconsole, Francesco; Vassallo, Camilla; Pietroleonardo, Lucia; Prignano, Francesca; Franchi, Chiara; Offidani, Anna Maria; Bonifati, Claudio; Di Lernia, Vito; Gigante, Giovanni; Bartezaghi, Marta Silvia; Franchi, Matteo; Ursoleo, Paola; Aloisi, Elisabetta

Russo, Filomena; Galluzzo, Marco; Stingeni, Luca; Persechino, Severino; Zichichi, Leonardo; Conti, Andrea; Giofrè, Claudia; Dini, Valentina; Vispi, Martina; Atzori, Laura; Cattaneo, Angelo; Parodi, Aurora; Bardazzi, Federico; Stinco, Giuseppe; Dapavo, Paolo; Girolomoni, Giampiero; Musumeci, Maria Letizia; Papini, Manuela; Venturini, Marina; Dastoli, Stefano; Di Nuzzo, Sergio; Fargnoli, Maria Concetta; Pagnanelli, Gianluca; Bernardini, Nicoletta; Gambini, Daniele Mario; Malagoli, Piergiorgio; Mazzatenta, Carlo; Peris, Ketty; Zalaudek, Iris; Fabbrocini, Gabriella; Loconsole, Francesco; Vassallo, Camilla; Pietroleonardo, Lucia; Prignano, Francesca; Franchi, Chiara; Offidani, Anna Maria; Bonifati, Claudio; Di Lernia, Vito; Gigante, Giovanni; Bartezaghi, Marta Silvia; Franchi, Matteo; Ursoleo, Paola; Aloisi, Elisabetta.

Afiliação

Russo F; Dermatology Section, Department of Medical, Surgical and Neurological Science, University of Siena, S. Maria Alle Scotte Hospital, Siena, Italy.
Galluzzo M; Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.
Stingeni L; Dermatology Unit, Fondazione Policlinico "Tor Vergata", Rome, Italy.
Persechino S; Section of Dermatology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
Zichichi L; Dermatology Unit, NESMOS Department, Faculty of Medicine & Psychology, Sapienza University of Rome, Sant'Andrea University Hospital, Rome, Italy.
Conti A; Unit of Dermatology, San Antonio Abate Hospital, Trapani, Italy.
Giofrè C; Section of Dermatology, Department of Specialized Medicine, University of Modena and Reggio Emilia, Modena, Italy.
Dini V; U.O.C. Dermatologia, A.O. Papardo, Messina, Italy.
Vispi M; Section of Dermatology, Department of Medicine and Oncology, University of Pisa, Pisa, Italy.
Atzori L; Dermatology Unit, Misericordia Hospital, Grosseto, Italy.
Cattaneo A; Dermatology Unit, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
Parodi A; Dermatology Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, Italy.
Bardazzi F; Section of Dermatology, DiSSal University of Genoa, Ospedale-Policlinico San Martino IRCCS, Genova, Italy.
Stinco G; Dermatology Division, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.
Dapavo P; Section of Dermatology, Department of Medicine, University of Udine, Udine, Italy.
Girolomoni G; Section of Dermatology, Department of Medical Sciences, University of Turin, Turin, Italy.
Musumeci ML; Section of Dermatology, Department of Medicine, University of Verona, Verona, Italy.
Papini M; Section of Dermatology, Department of Medical and Surgical Specialties, University of Catania, Catania, Italy.
Venturini M; Dermatology Clinic of Terni, University of Perugia, Perugia, Italy.
Dastoli S; Section of Dermatology, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
Di Nuzzo S; Department of Health Sciences, Magna Graecia University, Catanzaro, Italy.
Fargnoli MC; Department of Medicine and Surgery, University of Parma, Parma, Italy.
Pagnanelli G; Section of Dermatology, Department of Biotechnological and Applied Clinical Science, University of L'Aquila, L'Aquila, Italy.
Bernardini N; Department of Dermatology, Istituto Dermopatico dell'Immacolata - IRCCS, Roma, Italy.
Gambini DM; Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Dermatology Unit, "Daniele Innocenzi", Asl Latina, Italy.
Malagoli P; Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy.
Mazzatenta C; Dermatology Unit, Azienda Ospedaliera San Donato Milanese, Milan, Italy.
Peris K; Dermatology Unit, Lucca Azienda USL Toscana Nord Ovest, Pisa, Italy.
Zalaudek I; Department of Translational Medicine and Surgery, IRCCS A. Gemelli University Polyclinic Foundation, Sacred Heart Catholic University, Rome, Italy.
Fabbrocini G; Department of Dermatology, University of Trieste, Trieste, Italy.
Loconsole F; Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
Vassallo C; Department of Dermatology, University of Bari, Bari, Italy.
Pietroleonardo L; Institute of Dermatology, IRCCS Policlinico San Matteo Foundation and University of Pavia, Pavia, Italy.
Prignano F; Dermatology Unit, Vito Fazzi Hospital, Lecce, Italy.
Franchi C; Dermatology Clinic, Department of Health Sciences, University of Florence, Florence, Italy.
Offidani AM; Dermatology Unit, IRCCS IO Galeazzi, Milan, Italy.
Bonifati C; Dermatological Clinic, Polytechnic University of the Marche Region, Ancona, Italy.
Di Lernia V; Department of Dermatology, Istituto Dermatologico San Gallicano - IRCCS, Roma, Italy.
Gigante G; Dermatology Unit, Arcispedale S. Maria Nuova IRCCS, Reggio Emilia, Italy.
Bartezaghi MS; Novartis Farma SpA, Origgio, Italy.
Franchi M; Novartis Farma SpA, Origgio, Italy.
Ursoleo P; National Centre for Healthcare Research and Pharmacoepidemiology, Milan, Italy.
Aloisi E; Laboratory of Healthcare Research and Pharmacoepidemiology, Department of Statistics and Quantitative Methods, University of Milano Bicocca, Milan, Italy.

Clin Cosmet Investig Dermatol ; 16: 3561-3574, 2023.

Article em En | MEDLINE | ID: mdl-38107670

ABSTRACT

ABSTRACT

Purpose:

SUPREME, a phase IIIb study conducted in Italy, demonstrated safety and high efficacy of secukinumab for up to 72 weeks in patients with moderate-to-severe plaque-type psoriasis. SUPREME 2.0 study aimed to provide real-world data on the long-term drug survival and effectiveness of secukinumab beyond 72 weeks. Patients and

Methods:

SUPREME 2.0 is a retrospective observational chart review study conducted in patients previously enrolled in SUPREME study. After the end of the SUPREME study, eligible patients continued treatment as per clinical practice, and their effectiveness and drug survival data were retrieved from medical charts.

Results:

Of the 415 patients enrolled in the SUPREME study, 297 were included in SUPREME 2.0; of which, 210 (70.7%) continued secukinumab treatment throughout the 42-month observation period. Patients in the biologic-naïve cohort had higher drug survival than those in the biologic-experienced cohort (74.9% vs 61.7%), while HLA-Cw6-positive and HLA-Cw6-negative patients showed similar drug survival (69.3% and 71.9%). After 42 months, Psoriasis Area and Severity Index (PASI) 90 was achieved by 79.6% of patients overall; with a similar proportion of biologic-naïve and biologic-experienced patients achieving PASI90 (79.8% and 79.1%). The mean absolute PASI score reduced from 21.94 to 1.38 in the overall population, 21.90 to 1.24 in biologic-naïve and 22.03 to 1.77 in biologic-experienced patients after 42 months. The decrease in the absolute PASI score was comparable between HLA-Cw6-positive and HLA-Cw6-negative patients. The baseline Dermatology Life Quality Index scores also decreased in the overall patients (10.5 to 2.32) and across all study sub-groups after 42 months. Safety was consistent with the known profile of secukinumab, with no new findings.