(120) How much frequently are biological drugs used in patients over 65 years with immune-mediated inflammatory diseases through the Italian VALORE distributed database network

Background: Only limited evidence about how much and how biological drugs are used in elderly patients affected by immune-mediated inflammatory diseases (IMID) is available.

Objectives: To evaluate the pattern of use of biological drugs in elderly patients (≥ 65 years old) with IMID (Crohn’s disease (CD), ulcerative colitis (CU), psoriatic arthritis (PsA), psoriasis (PsO), rheumatoid arthritis (RA), and ankylosing spondylitis (AS)) in a large-scale Italian population.

Methods: A retrospective cohort study was conducted using claims data from the VALORE distributed database network covering 13 Italian regions. Demographic and clinical characteristics of elderly incident biological drug users (no dispensing before the first biological drug dispensing, i.e., index date -ID) between 2010 and 2022 were evaluated. For each calendar year the overall ratio (per 100.000 elderly residents) of prevalent use of biological drugs was measured and stratified by age groups and sex. Moreover, the distribution of incident treatments by treatment line of biological drug, active ingredient, calendar year, and indication for use was described. Persistence to index drug was measured as the number of days from ID to discontinuation date (including 60-day grace period) or to date of switching to a different biological drug.

Results: A total of 20,683 older patients with IMID who were newly treated with biological drugs in the period 2010-2022 were identified. Elderly biological drug users reported a mean age of 71.5 years (9% ≥ 80 years), F/M ratio=1.6, and were mostly treated because of RA and PsO. From the source population, 32,241 prevalent users between 2010 and 2022, at least 65 years old were identified. The prevalence of biological drug use in elderly patients increased over the study period (from 2010 to 2022: + 536%). The frequency use of anti-interleukin drugs was lower among first-line treatments than second- and third-line treatments (PsO/PsA: 30.6% vs. 43.8% and 61.1%; IBDs: 4.2% vs. 11.5% and 34.9%; RA and SpA: 14.5% vs. 27.2% and 35.6%). Over the years, the proportion of first-line use of TNF-alpha decreased for all indications (PsO/PsA from 88.1% in 2011 to 58.9% in 2022 – CD/UC from 100% in 2011 to 41.8% in 2022 – RA/SpA from 80.2% in 2011 to 66.9% in 2022). Overall, 54% of patients were persistent to index biological therapy at 1 year of follow-up (36% at 2 years and 17% at 5 years). The highest treatment persistence rate was observed for vedolizumab and ustekinumab users in CD/UC and ustekinumab users in PsO/PsA. As for the rheumatological area, patients showed rather comparable treatment persistence to index drug across different molecules except for secukinumab (approved only for ankylosing spondylitis), reporting the lowest median time to discontinuation of 296 days [IQR 204; 372]

Conclusions: The distribution of incident treatments with biological drugs shows a difference in the use of different classes according to treatment line (anti-TNF were more commonly used as first.line treatment). In terms of persistence, patients with inflammatory bowel disease who started with ustekinumab and vedolizumab showed the highest persistence to treatment.