Study identification

EU PAS number

EUPAS25364

Study ID

31712

Official title and acronym

Spanish Registry of Atopic Dermatitis (BIOBADATOP)

DARWIN EU® study

No

Study countries

Spain

Study description

Registries have shown to be an important pharmacovigilance strategy, as they provide data on non-selected populations, with long periods of follow-up and with comparison groups that allow for the calculation of meaningful risks. Previous experiences in psoriasis, including Biobadaderm (the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology) and Psonet (European Network of Psoriasis Registries), have shown the importance of establishing specific registers of patients treated with systemic therapies to describe long term safety of therapy.As happened with psoriasis, over the last years, new immunomodulatory drugs are been developed for the treatment of adults with moderate-to-severe atopic dermatitis (AD). They all affect specific immune pathways and raise safety concerns related to all immunomodulatory drugs. Dupilumab is the first biologic that has been approved by the FDA and the EMA, for the treatment of adults with AD. We expect new drugs for AD to reach the market in the next decade, leading to an increased use of dupilumab and the progressive addition of new molecules. Considering that the prevalence of AD is high in the population and the severe impairment in the quality of life of the patients, there are many potential users. For this reason, knowing their side effects in real life use in the shortest period of time is an important public health objective. Many other outcomes can be relevant in an AD registry, including effectiveness outcomes. We will take advantage of the previous work done by the “Harmonising Outcome Measures for Eczema”(HOME) initiative, that has studied and described the validity of outcome measures in atopic dermatitis.The Spanish Registry of Systemic therapy in atopic eczema, BIOBADATOP, assesses drug safety and treatment effectiveness as well as treatment impact on quality of life in children and adults with atopic eczema receiving systemic immuno-modulatory therapies in Spanish daily practice.

Study status

Ongoing
Research institutions and networks

Institutions

Hospital Universitario de Gran Canaria Doctor Negrín Las Palmas, Gran Canaria, Spain, Hospital de la Princesa Madrid, Spain, Hospital del Mar Barcelona, Spain, Hospital Miguel Servet Zaragoza, Spain, Hospital Santa Creu i Sant Pau Barcelona, Spain

Networks

Contact details

Ignacio García-Doval

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Own, Sanofi, Pfizer, Abbvie, Almirall.
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable