Real-World Outcomes of a Non-Medical Switch to Adalimumab-Atto Biosimilar: Safety, Effectiveness, and Treatment Persistence in an Adult Saudi Tertiary Care Population.

Authors

Alhanouf Almousa, Mohamed Ahmed, Rayd Abdulaziz Almehizia, Meshal Aldurayhim, Gamal Mohamed, Almutairdi Abdulelah, Yousef Binamer, Ahmed Alshaikh

Published in

Biologics : targets & therapy. Volume 20. Pages 612345. Epub Oct 12, 2026.

Abstract

Adalimumab-atto, a biosimilar to adalimumab, has been widely adopted for managing autoimmune conditions due to its demonstrated safety, efficacy, and cost-effectiveness in clinical trials. However, real-world data from Saudi Arabian population remains limited.
This study aimed to evaluate the persistence, safety, and clinical outcomes of patients transitioned from originator adalimumab (Humira^®) to adalimumab-atto biosimilar (Amgevita^®) at a tertiary care center.
A retrospective self-controlled cohort study was conducted, including all patients transitioned to adalimumab-atto between January 1 and December 31, 2022, for non-medical reasons. The primary endpoint was treatment persistence at 12 months. Secondary endpoints included disease stability, adverse events, and reasons for discontinuation.
The study included 265 adult patients previously treated with originator adalimumab. The mean age of the cohort was 41 ± 13 years, with 46.8% being female. The most common indications were Crohn's disease (40.4%), rheumatoid arthritis (16.6%), and plaque psoriasis (12.1%), with a mean disease duration of 11.7 ± 6.7 years. At 12 months, 90.2% of patients persisted with adalimumab-atto, of whom 79.5% remained stable, while 20.5% were classified as unstable Twenty-six patients (9.8%) discontinued therapy, primarily due to insufficient efficacy (13 patients), with one discontinuation attributed to adverse events.
Adalimumab-atto demonstrated high treatment persistence and favorable safety outcomes in a diverse population of patients with autoimmune diseases. These findings support the feasibility of continued use of the biosimilar in patients with immune-mediated diseases.

PMID:
42891392
Bibliographic data and abstract were imported from PubMed on 18 Oct 2026.

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