Estimation of Patients With Psoriasis Potentially Eligible to Biologic Agents and Not Currently Treated With These Therapies: Analysis of Real-World Data in Italy

OBJECTIVES: A real-world data analysis in Italy was carried out to estimate the number of patients with psoriasis (PSO) potentially eligible for biologics.

METHODS: An observational analysis was performed on administrative databases of a sample of Italian Entities, covering 11.3% of Italian population. Between 2010-2020 (inclusion period), PSO patients were identified by: (a) ≥1 prescription of topical drugs (ATC code D05A), or (b) exemption for PSO (code 045.696.1), or (c) ≥1 PSO hospitalization (discharge diagnosis code ICD-9-CM 696.1). The index-date was defined as the first PSO identification across inclusion period. Eligibility for biologics was evaluated prior to index-date (characterization period) if meeting: Criterion A, failure of ≥1 systemic conventional treatment, and/or Criterion B, patients experiencing psoriatic arthritis (PsA) before or after PSO identification. Co-morbidities, referred as contraindications for conventional treatments, were also recorded. Data were re-proportioned considering the entire Italian population.

RESULTS: PSO prevalence was estimated as 2% of the overall population. Considering the Italian population at 2020 (n=59.236.213), 1.43 million of PSO patients were identified, with 1.41 million (99%) being treated: 1.35 million (95%) with no-biologic therapies, 56,319 (3.9%) with biologics, while 13,490 (1%) were untreated. Among patients untreated or treated with no-biologic therapies, 53,906 (3.8% of overall PSO) met at least one criterion for eligibility to biologics, specifically 25% met the eligibility criterion A (failure to conventional treatments), and 68% the criterion B (PsA co-diagnosis), and 7% met both criteria. Among patients potentially eligible, 26% and 24% had 1 or 2 comorbidities, respectively, and 30% presented 3 or more comorbidities.

CONCLUSIONS: This analysis, carried out in a real clinical practice setting, estimate at national level PSO patients potentially eligible for biologics. The results show that about 4% of PSO patients presented at least one or more eligibility criteria for these therapies. Additionally, nearly 30% exhibited a complex clinical profile with multiple comorbidities.