Publications

Authors:

Spini, Andrea; L'Abbate, Luca; Ingrasciotta, Ylenia; Carollo, Massimo; Bellitto, Chiara; Leoni, Olivia; Zanforlini, Martina; Ancona, Domenica; Stella, Paolo; Cavazzana, Anna; Scapin, Angela; Lopes, Sara; Belleudi, Valeria; Ledda, Stefano; Carta, Paolo; Rossi, Paola; Ejlli, Lucian; Sapigni, Ester; Puccini, Aurora; Scarpelli, Rita Francesca; De Sarro, Giovambattista; Allotta, Alessandra; Pollina, Sebastiano Addario; Da Cas, Roberto; Bucaneve, Giampaolo; Mangano, Antea Maria Pia; Balducci, Francesco; Sorrentino, Carla; Senesi, Ilenia; Tuccori, Marco; Gini, Rosa; Trama, Ugo; Bernardi, Francesca Futura; Mayer, Flavia; Alegiani, Stefania Spila; Massari, Marco; Guarneri, Claudio; Gisondi, Paolo; Fontana, Andrea; Patorno, Elisabetta; Trifirò, Gianluca

Title:

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 of item:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Language:

Inglese

Format:

Elettronico

Referee:

No

Name of journal:

Pharmacological Research

ISSN of journal:

1043-6618

N° Volume:

228

Page numbers:

1-8

Keyword:

biologics; infections; long-term risk; older patients; psoriasis; psoriatic arthritis; real-world evidence

Short description of contents:

: 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=2,256) compared to adalimumab (n=6,441) 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.

Note:

Available online 20 April 2026

Product ID:

150979

Handle IRIS:

11562/1190189

Last Modified:

April 26, 2026

Bibliographic citation:

Spini, Andrea; L'Abbate, Luca; Ingrasciotta, Ylenia; Carollo, Massimo; Bellitto, Chiara; Leoni, Olivia; Zanforlini, Martina; Ancona, Domenica; Stella, Paolo; Cavazzana, Anna; Scapin, Angela; Lopes, Sara; Belleudi, Valeria; Ledda, Stefano; Carta, Paolo; Rossi, Paola; Ejlli, Lucian; Sapigni, Ester; Puccini, Aurora; Scarpelli, Rita Francesca; De Sarro, Giovambattista; Allotta, Alessandra; Pollina, Sebastiano Addario; Da Cas, Roberto; Bucaneve, Giampaolo; Mangano, Antea Maria Pia; Balducci, Francesco; Sorrentino, Carla; Senesi, Ilenia; Tuccori, Marco; Gini, Rosa; Trama, Ugo; Bernardi, Francesca Futura; Mayer, Flavia; Alegiani, Stefania Spila; Massari, Marco; Guarneri, Claudio; Gisondi, Paolo; Fontana, Andrea; Patorno, Elisabetta; Trifirò, Gianluca, 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 «Pharmacological Research» , vol. 228 , 2026 , pp. 1-8

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