NCT04808739

Adalimumab Biosimilar in Clinical Practice

Retrospective Observational Study to Analyze the Effectiveness of Adalimumab

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 604 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 2 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This is an observational, retrospective, multicenter, and descriptive study of patients treated with adalimumab biosimilar for psoriasis, according to clinical practice. Existing data will be collected from the Dermatology Services database of the hospitals participating in the study, from the medical histories of all treated patients who meet the inclusion criteria and sign informed consent. The aim of the study is to determine the effectiveness of the different adalimumab biosimilars in clinical practice.

Detailed description

Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic treatment. There are currently several biosimilar drugs (Amgevita, Imraldi, Hyrimoz, Idacio, Hulio,…) in addition to the reference product (Humira). The reduction in the cost of production of biosimilar drugs with respect to reference products has led to their replacement by biosimilar drugs in patients initiating biological therapy, but some centers are also switching to adalimumab biosimilar in patients who are controlled with original adalimumab (Humira). There are no actual clinical efficacy / safety data in our setting on the use of adalimumab biosimilars. There is also no evidence of maintenance response in patients who are switched from adalimumab (Humira) to biosimilar adalimumab in clinical practice. This retrospective study will collect demographic and disease data of the psoriasis patient treated with the different biosimilars of adalimumab, as well as their comorbidities, response to treatment, and safety. In this way, data will be available in usual clinical practice to improve the management of the patient with psoriasis treated with biosimilar drugs.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab	Analysis of survival of adalimumab biosimilar in clinical practice

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2021-03-22
• Last updated: 2021-03-22

Locations

1 site across 1 country: Spain