Frequency of Biological Drug Use in Older Patients with Immune-Mediated Inflammatory Diseases: Results from the Large-Scale Italian VALORE Distributed Database Network

Background: Limited real-world data on biological drug use in older patients with immune-mediated inflammatory diseases (IMIDs) exist despite these drugs carrying serious risks in this population. Objective: We aimed to describe the frequency and persistence of biological drug use in older patients (≥ 65 years) with IMID, including inflammatory bowel diseases (IBDs), psoriatic arthritis/psoriasis, rheumatoid arthritis (RA), and ankylosing spondylitis, in a large Italian population. Methods: A retrospective cohort study using the VALORE distributed claims database network from 13 Italian regions in the years 2010-2022 was performed. Older patients with IMID receiving biological drugs were included. Yearly prevalence of biological drug use and treatment persistence among incident users, from first dispensing to discontinuation/switching to another drug, was measured. Multivariable logistic regression was employed to identify treatment discontinuation predictors. Results: The prevalence of biological drug use in older patients with IMID increased dramatically from 2010 (0.44 per 1000 residents) to 2022 (2.48 per 1000 residents). Overall, 25,284 incident users of biological drugs were identified, with a female/male ratio of 1.6 and a mean age of 71.0 (standard deviation ± 5.2) years. The median duration of follow-up was 4.2 (2.5-6.6) years, and the most common indication for use was RA (n = 8371; 33.1%). Overall, biological drug persistence was 54.4% at 1 year from treatment start. The highest persistence rates were found for vedolizumab and ustekinumab in patients with IBD (ulcerative colitis, 68.1% and 76.2%, respectively; Crohn's disease, 69.6% and 88.1%, respectively). Polypharmacy, advanced age, and female sex were identified as predictors of treatment discontinuation. Conclusions: This study documented a significant rise in biological drug use among older patients with IMID in Italy over the last decade. Around 50% of users discontinued treatment after the first year, with even higher rates observed in very old patients with polypharmacy. These findings highlight potential concerns about the use of biological therapies in older patients and underscore the urgent need for large-scale cohort studies to address the current knowledge gaps regarding their safety and effectiveness in this vulnerable population.