Resumen

Objetivo primario: Caracterizar a los pacientes que reciben Dupixent® (dupilumab) para DA en un entorno de práctica clínica real, en lo que respecta a su historial médico, características sociodemográficas y de la enfermedad, y tratamientos previos y concomitantes de la DA. Objetivos secundarios: * Caracterizar los patrones de uso de Dupixent® en práctica clínica real para la DA (por ejemplo, regímenes utilizados, motivo del inicio de nuevos tratamientos, terapias concomitantes, duración de los tratamientos y motivos de discontinuación y/o cambio de tratamiento). * Evaluar la efectividad a largo plazo de Dupixent® en pacientes con DA en un entorno de práctica clínica real. * Evaluar las condiciones atópicas comórbidas y los efectos del tratamiento en dichas condiciones en pacientes que reciben Dupixent® para DA. * Recopilar datos de seguridad de los participantes en el estudio.

Descripción detallada

Los participantes inscritos en el estudio serán seguidos durante 5 años.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Male or female, 12 years or older at the baseline visit. Note: Adolescent participants (at least 12 years old, but less than 18 years) are eligible only after Dupixent® receives the respective country's regulatory approval for use in this age group;
Initiating treatment with Dupixent® for AD according to the country-specific prescribing information. Note: Participants may be eligible if they have already initiated treatment with Dupixent® for AD within 6 months before their enrollment in the registry, provided that all core baseline data required (Eczema Area and Severity Index \[EASI\], Scoring of Atopic Dermatitis \[SCORAD\], body surface area \[of AD involvement\] \[BSA\], Patient-Oriented Eczema Measure \[POEM\], and Dermatology Life Quality Index \[DLQI\]) by the registry protocol were captured at the time of initiating Dupixent® treatment and are available for entry in the registry database
Able to understand and complete study-related questionnaires
Provide signed informed consent or parental/legally acceptable representative consent and/or patient assent where applicable

Criterios de exclusión

Participants who have a contraindication to the drug according to the country-specific prescribing information label
Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other co-morbidities that can predictably prevent the participant patient from adequately completing the schedule of visits and assessments
Patients currently participating in any interventional clinical trial which modifies patient care
Prior use of Dupixent® within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Intervenciones

drug

Dupilumab SAR231893 (REGN668)

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Ubicaciones

Investigational Site Number : 0320013

Pilar, Buenos Aires, Argentina

Investigational Site Number : 0320012

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320011

Ciudad Autonoma Bs As, Argentina

Patrocinadores

PrincipalSanofi

ColaboradorRegeneron Pharmaceuticals

Estudio observacional prospectivo de pacientes que reciben Dupixent® para dermatitis atópica