Adalimumab Biosimilar in Clinical Practice

Completed

• Conditions: Psoriasis

• Registration Number: NCT04808739
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-18
• Last Update Submitted: 2021-03-18
• Study First Posted: 2021-03-22
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 604

Inclusion Criteria

• Patients of both sexes who have received treatment with adalimumab and who have signed an informed consent.

Exclusion Criteria

• Refusal to participate.
• Any other cause of exclusion based on clinical criteria and the technical data sheet of the drug.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median time of survival (months) of adalimumab biosimilar in clinical practice	1 year	Median time of survival (months) of patients under treatment with adalimumab biosimilar in clinical practice

Trial Locations

Locations (1)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain