Study identification

EU PAS number

EUPAS1000000110

Study ID

1000000110

Official title and acronym

Primary Sjögren’s syndrome in Italy: real-world evidence of a rare disease through administrative healthcare data

DARWIN EU® study

No

Study countries

Italy

Study description

Objectives
Primary Sjögren’s syndrome (pSS) is a systemic autoimmune disease with significant impact on morbidity, mortality, and quality of life. This study aimed to evaluate epidemiology, healthcare needs and related costs of pSS patients, from the Italian National Health Service (INHS) perspective.

Methods
From the Fondazione Ricerca e Salute’s database (~5 million inhabitants/year), pSS prevalence in 2018 was calculated. Demographics, mean healthcare consumptions and direct costs at one year following index date (first in-hospital diagnosis/disease waiver claim) were analysed through an individual direct matched pair case-control analysis (age, sex, residency).

Conclusion
According to the results of this population-based study, the prevalence of pSS in Italy appears to be consistent with the definition of rare disease. Patients with pSS have higher pharmacological, in-hospital and outpatient specialist care needs, leading to three-times higher overall cost for the INHS, compared to the general population.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Letizia Dondi

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
Non-for-profit organisation (e.g. charity)

More details on funding

This study was unconditionally supported by the Italian Association of people with Sjögren’s syndrome (A.N.I.Ma.S.S. ODV - Associazione Nazionale Italiana Malati Sindrome Sjögren).
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable