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Evaluation Video

Oral Presentation

Session: Lightning Session 1

Risk of serious infections in psoriasis/psoriatic arthritis biological drug users: a large-scale, propensity score matched cohort study using the Italian VALORE Project distributed database

Monday, August 26, 2024
5:15 PM – 5:20 PM CEST
Location: Room III
Background: Limited evidence exists on comparative risk of severe infections among biological drug users in a large cohort of patients affected by Psoriasis (PsO) / psoriatic arthritis (PsA) including more recently approved drugs.

Objectives: To evaluate the association between the exposure to biologics in PsO/PsA patients and the occurrence of severe infection as cause of hospitalization by drug class and individual molecules.

Methods: A retrospective, propensity score-matched cohort study was conducted using data from Italian VALORE distributed database network. Incident users (no use biologics in the year before the first dispensing, i.e. index date) of biological drugs in PsO/PsA patients with at least one year look-back period were selected during the study period 2011-2021. Hospitalization due to severe infection was considered as the outcome of interest. To compute propensity score, logistic regression was used to predict the individual probability of receiving each drug class (TNF-alpha inhibitors or anti-interleukin/selective immunosuppressive therapy) according to age, gender, region, calendar year, previous use of cDMARDs, other drugs and comorbidities. Patients in the drug classes were thus matched according to propensity score. Patients were followed from index date to outcome, death, end of study period, biological switch or discontinuation, whichever occurred first. Cox Proportional-Hazards regression model was used to estimate the risk by classes and for single molecules (based on multivariate model) at 6, 12 and 24 months after index date.

Results: Overall, 32,282 incident users of biological drugs with PsO/PsA were included in the study cohort. A total of 23,049 users of TNF-alpha inhibitors, 8,584 users of anti-interleukins and 649 abatacept users were included. The overall incident rate of severe infection during biological drug exposure was overall 11.1 per 1.000 PYs. No significant difference in terms of risk was observed between drug classes at 6, 12 and 24 months. A significantly lower risk of severe infection was observed at two years in incident users of etanercept (HR 0.29: 95%CI: 0.12-0.67; p-value: 0.004), secukinumab (HR 0.38: 95%CI:0.17-0.82; pvalue: 0.015) and ustekinumab (HR 0.45: 95%CI: 0.21-0.97; pvalue: 0.042) as compared to infliximab.

Conclusions: No significant difference in the risk of severe infections between drug classes in patients with PsO/PsA was observed. In line with previous published literature, a lower risk of severe infections was however observed for individual biologics such as etanercept, secukinumab and ustekinumab as compared to infliximab at two years after the index date.