Patient-Level Cumulative Clinical Benefit of Brodalumab Over 52 Weeks: A Multicentre Real-World Study-IL PSO (Italian Landscape Psoriasis).
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Potestio Luca, Corrao Salvatore, Mastorino Luca, Gaiani Francesca Maria, Cozzani Emanuele Claudio, Maurelli Martina, Tommasino Nello, Caccavale Stefano, Gargiulo Luigi, Carrera Carlo Giovanni, Sacchelli Lidia, Longo Caterina, Marchetti Sara, Michelucci Alessandra, Valguarnera Dario, Carugno Andrea, Mozzato Simone, Lussana Francesca, Mercadante Lorenzo, Cangialosi Luca, Messina Francesco, Di Brizzi Eugenia Veronica, Bianco Matteo, Scibetta Salvatore, Assorgi Chiara, Campoli Marco, Angileri Rosa Giuseppa, Dattola Annunziata, Trovato Emanuele, Esposito Maria, Zerbinati Nicola, Guarneri Claudio, Loconsole Francesco, Dini Valentina, Campanati Anna, Lasagni Claudia, Bardazzi Federico, Marzano Angelo Valerio, Travaglini Massimo, Narcisi Alessandra, Balato Anna, Megna Matteo, Girolomoni Giampiero, Burlando Martina, Malagoli Piergiorgio, Ribero Simone, Orsini Diego
Аннотация
METHODS: This multicentre, retrospective, observational study included adults with moderate-to-severe plaque psoriasis treated with brodalumab within the Italian Landscape Psoriasis database. The primary analysis included patients with PASI assessments at baseline and Weeks 16, 32, and 52. Individual percentage PASI improvement trajectories were integrated using the trapezoidal area under the curve and expressed as normalized cumulative clinical benefit and clearance-equivalent days. Baseline factors associated with cumulative benefit were assessed using multivariable median quantile regression.
RESULTS: Among 858 patients eligible for the 52-week analysis, 764 had complete longitudinal PASI data, and 645 were included in the multivariable analysis. Median PASI decreased from 14.7 at baseline to 0.0 at Weeks 16, 32, and 52. At Week 52, 93.1%, 86.1%, and 70.4% of patients achieved PASI 75, PASI 90, and PASI 100, respectively. Median normalized cumulative clinical benefit was 97.4% (interquartile range, 90.0-100.0), corresponding to 300.0 clearance-equivalent days (277.2-308.0). Palmoplantar involvement was independently associated with lower cumulative benefit (adjusted median difference, - 3.21 percentage points; 95% confidence interval, - 6.29 to - 0.87), whereas scalp or facial involvement was associated with modestly higher benefit (+ 1.39; 0.38-3.27). Longer psoriasis duration was associated with a small increase in cumulative benefit.
CONCLUSION: Brodalumab provided rapid, deep, and sustained disease control over 52 weeks. Patient-level cumulative outcomes may complement conventional PASI response rates by capturing the overall longitudinal treatment benefit.