DARWIN EU® - Clinical characteristics and treatments used in adult and paediatric patients with systemic lupus erythematosus: a multinational European cohort study

04/11/2026
04/11/2026
EU PAS number:
EUPAS1000001164
Study
Ongoing
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Study identification

EU PAS number

EUPAS1000001164

Study ID

1000001164

Official title and acronym

DARWIN EU® - Clinical characteristics and treatments used in adult and paediatric patients with systemic lupus erythematosus: a multinational European cohort study

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Spain
Sweden
United Kingdom

Study description

Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder that can affect multiple organ systems, including the skin, joints, kidneys, nervous system, haematologic, and cardiovascular systems. It is characterised by autoantibodies targeting nuclear or phospholipid antigens, a relapsing disease course with remissions and flares, and a highly variable clinical presentation, disease course, and prognosis.
The estimated incidence of childhood-onset SLE is between 0.3 and 2.5 per 100,000 children. Although childhood-onset SLE shares many features with adult-onset SLE, including its pathogenesis and laboratory findings, it is generally associated with a more severe prognosis and different patterns of organ involvement. While treatment principles and drug classes used in childhood- and adult-onset SLE are similar, clinical management in children and adolescents must also account of the different licensed treatment in the two age groups.
Recent Real-World Evidence generated in the context of DARWIN EU®, and including data from four European countries, has shown that hydroxychloroquine and glucocorticoids remain the predominant first-line therapies in both adults and children, but paediatric patients are more likely to receive higher initial glucocorticoid doses compared to adults, highlighting the need for steroid-sparing strategies and for further research to inform paediatric SLE management.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Xintong Li

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA

More details on funding

No information provided.
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable