Comparative risk of serious infections across biological drugs in patients with psoriatic arthritis or psoriasis: A target trial emulation using the Italian VALORE distributed database network
Year: 2026
Type: article
Study design: Observational Study
Abstract: Risk of serious infections with biological drugs for psoriasis (PsO) and psoriatic arthritis (PsA) remains uncertain, particularly with long-term exposure and in older adults. We aimed to assess the comparative risk of serious infections among biological agents used for PsO/PsA. Using the Italian VALORE distributed database (2015-2021), we conducted a retrospective cohort study replicating the EXCEED trial (adalimumab vs. secukinumab), followed by a second-stage cohort extending follow-up, restricting analyses to older patients, and comparing other biological drugs. For replication, new users of adalimumab or secukinumab with PsO/PsA meeting observational analogues of EXCEED eligibility criteria were included. Additional new-user cohorts of etanercept, infliximab, ixekizumab, and ustekinumab were selected in second-stage analyses. Hazard ratio (HR) of hospitalization for serious infections was evaluated using Cox models. In second-stage cohort, the risk was evaluated over a long-term follow-up (3years) and in older patients. Risk of serious infection was similar for secukinumab (n = 2256) compared to adalimumab (n = 6441) at 1 year (HR:0.74 [CI:0.36-1.48]), consistent with EXCEED estimates (p = 0.54). No significant differences were observed at 3 years (HR:0.70 [CI:0.42-1.18]) or in older adults (HR:1.25 [CI:0.40-3.95]). Compared with adalimumab, infliximab showed higher risk (HR:2.66 [CI:1.04-6.78]), whereas ixekizumab showed a lower risk in older adults (HR:0.12 [CI:0.01-0.92]). Overall, incidence rates were higher among older users, with similar estimates across short- and long-term follow-up periods. Infliximab was the only biological drug associated with a higher risk of serious infections compared with adalimumab. Older adults had higher incidence rates, with comparable risks across short- and long-term treatment.
Source: Pharmacological Research
Authors: Andrea Spini, Luca L’Abbate, Ylenia Ingrasciotta, Massimo Carollo, Chiara Bellitto, Olivia Leoni, Martina Zanforlini, Domenica Ancona, Paolo Stella, Anna Cavazzana, Angela Scapin, Sara Lopes, Valeria Belleudi, Stefano Ledda, Paolo Carta, Paola Rossi, Lucian Ejlli, Ester Sapigni, Aurora Puccini, Rita Francesca Scarpelli, Giovambattista De Sarro, Alessandra Allotta, Sebastiano Addario Pollina, Roberto Da Cas, Giampaolo Bucaneve, Antea Maria Pia Mangano, Francesco Balducci, Carla Sorrentino, Ilenia Senesi, Marco Tuccori, Rosa Gini, Ugo Trama, Francesca Futura Bernardi, Flavia Mayer, Stefania Spila Alegiani, Marco Massari, Claudio Guarneri, Paolo Gisondi, Andrea Fontana, Elisabetta Patorno, Gianluca Trifirò
Institutions: University of Verona, Regione Puglia, Regione del Veneto, Regione Lazio, Regione Autonoma della Sardegna, Regione Autonoma Friuli Venezia Giulia, Regione Emilia-Romagna, Regione Calabria, Magna Graecia University, Regione Siciliana, Istituto Superiore di Sanità, Regione Umbria, Regione Marche, Regione Abruzzo, Agenzia Regionale di Sanità della Toscana, Regione Campania, University of Campania "Luigi Vanvitelli", University of Messina, Casa Sollievo della Sofferenza, Brigham and Women's Hospital, Harvard University
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,130
OpenAlex ID: W7155018167