Acute viral bronchiolitis before and after implementation of nirsevimab prophylaxis in Italy: a multicentre retrospective cohort study.
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Spatuzzo Mattia, Corsello Antonio, Riccò Matteo, Bonci Enea, Di Francesco Domenico, Strati Marina Francesca, Amodio Gianmarco, Manzalini Riccardo, Costantini Elisa, Mazzotti Sofia, Renni Marco, Coralluzzo Francesca, Langone Letizia, Fiumicelli Elena, Albonico Greta, Adornato Susanna, Passarella Valeria, Piras Antonella, Forcucci Francesca, Capuano Maria Cristina, Basile Anna, Albini Maria, Cafforio Alessia, Coppola Claudio, Palmoni Monica, Bertolucci Giulia, Bertolo Silvia, Di Febo Corrado, Donato Annalidia, Di Pasquale Gabriele, Toscano Fabio, Tolfa Grazia, Arpinelli Marta, Marseglia Gian Luigi, Agostiniani Rino, Midulla Fabio, ONSP-RSV Study Group
Аннотация
METHODS: We conducted a multicentre retrospective cohort study including infants <12 months with all-cause bronchiolitis during two seasons: pre-implementation (October 2023-April 2024) and post-implementation (October 2024-April 2025). Data were collected from 30 university hospitals across 15 regions using ICD-10 codes. Outcomes were compared using propensity score matching and multivariate regression analyses.
FINDINGS: Following implementation, emergency department visits decreased by 48% (5076 vs 2633), pediatric ward admissions by 48% (2734 vs 1473) and pediatric intensive care unit admissions by 61% (334 vs 131). Analyses adjusted for local rollout showed reductions of 82% (RR 0.18), 84% (RR 0.16) and 79% (RR 0.20), respectively. Post-implementation, infants were older (aOR 1.07, 95% CI 1.04-1.10) with lower odds for low- (aOR 0.67, 95% CI 0.55-0.82) and high-flow (aOR 0.8; 95% CI 0.65-0.99) oxygen-therapy. RSV remained predominant (934/1473, 63%), while non-RSV infections increased (334/2734, 12% vs 305/1473, 21%). Most infants had not received prophylaxis; 372 (25%) hospitalised despite nirsevimab were younger (5.2 ± 3.5 vs 2.8 ± 1.9, p < 0.001) and had more comorbidities (11%, 82/745 vs 22%, 37/168, p < 0.001).
INTERPRETATION: In Italy, nirsevimab was associated with reduced all-cause bronchiolitis-related utilisation and milder disease. Underlying conditions remained a determinant for severe outcomes despite prophylaxis.
FUNDING: No funding was received for this study.