Forty-Eight-Month Monitoring of Disease Activity in Patients with Long-Standing Rheumatoid Arthritis Treated with TNF-α Inhibitors: Time for Clinical Outcome Prediction and Biosimilar vs Biologic Originator Performance.

Journal

Clinical drug investigation
ISSN: 1179-1918
Titre abrégé: Clin Drug Investig
Pays: New Zealand
ID NLM: 9504817

Informations de publication

Date de publication:
31 Jan 2024
Historique:
accepted: 16 01 2024
medline: 31 1 2024
pubmed: 31 1 2024
entrez: 31 1 2024
Statut: aheadofprint

Résumé

Long-term treatment of patients with rheumatoid arthritis with tumor necrosis factor-α inhibitors leads to initial changes in disease activity that can predict a late treatment response. This observational and retrospective study aimed to determine when it is possible to foresee the response to therapy in the case of long-standing rheumatoid arthritis comparing also the efficacy of the original biologics with their biosimilars. A total of 1598 patients were recruited and treated with the original biologics, adalimumab and etanercept, or with biosimilars. Patients were monitored over a period of 48 months and disease activity scores (28-Joint Disease Activity Score, Simplified Disease Activity Index, and Clinical Disease Activity Index) were measured every 6 months. No differences in disease activity levels were observed in etanercept versus biosimilars (GP2015/SB4) and adalimumab versus biosimilar (GP2017) patient groups. All scores significantly decreased in all treatments during the first 18 months of therapy, and after 24 months reached a minimum that lasted up to 48 months. We conclude that biosimilars of adalimumab and etanercept have equivalent effectiveness over a long period of time compared to their originator drugs, and also that the levels of disease activity after 6 months of tumor necrosis factor-α inhibitors (originator drugs and biosimilars) might predict the response to therapy at 4 years in patients with long-standing rheumatoid arthritis.

Sections du résumé

BACKGROUND AND OBJECTIVES OBJECTIVE
Long-term treatment of patients with rheumatoid arthritis with tumor necrosis factor-α inhibitors leads to initial changes in disease activity that can predict a late treatment response. This observational and retrospective study aimed to determine when it is possible to foresee the response to therapy in the case of long-standing rheumatoid arthritis comparing also the efficacy of the original biologics with their biosimilars.
METHODS METHODS
A total of 1598 patients were recruited and treated with the original biologics, adalimumab and etanercept, or with biosimilars. Patients were monitored over a period of 48 months and disease activity scores (28-Joint Disease Activity Score, Simplified Disease Activity Index, and Clinical Disease Activity Index) were measured every 6 months.
RESULTS RESULTS
No differences in disease activity levels were observed in etanercept versus biosimilars (GP2015/SB4) and adalimumab versus biosimilar (GP2017) patient groups. All scores significantly decreased in all treatments during the first 18 months of therapy, and after 24 months reached a minimum that lasted up to 48 months.
CONCLUSIONS CONCLUSIONS
We conclude that biosimilars of adalimumab and etanercept have equivalent effectiveness over a long period of time compared to their originator drugs, and also that the levels of disease activity after 6 months of tumor necrosis factor-α inhibitors (originator drugs and biosimilars) might predict the response to therapy at 4 years in patients with long-standing rheumatoid arthritis.

Identifiants

DOI: 10.1007/s40261-024-01341-7 PMID: 38294672
pubmed: 38294672
doi: 10.1007/s40261-024-01341-7
pii: 10.1007/s40261-024-01341-7
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

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Auteurs

Matteo Colina (M)

UOC (Operative Complex Unit) of Internal Medicine, Rheumatology Service, Section of Internal Medicine, Department of Medicine and Oncology, "Santa Maria della Scaletta" Hospital, via Montericco 4, 40026, Imola, Italy. matteo.colina2@unibo.it.
Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy. matteo.colina2@unibo.it.
ORCID: 0000-0002-1174-2849

Micheline Khodeir (M)

Hospital Pharmacy, Ospedale Santa Maria della Scaletta, Imola, Italy.

Roberto Rimondini (R)

Alma Mater Studiorum, Medical and Surgical Sciences Department, University of Bologna, Bologna, Italy.

Marco Valentini (M)

Rheumatology Service, San Pier Damiano Hospital, Faenza, Italy.

Federica Campomori (F)

UOC (Operative Complex Unit) of Internal Medicine, Rheumatology Service, Section of Internal Medicine, Department of Medicine and Oncology, "Santa Maria della Scaletta" Hospital, via Montericco 4, 40026, Imola, Italy.

Stefania Corvaglia (S)

UOC (Operative Complex Unit) of Internal Medicine, Rheumatology Service, Section of Internal Medicine, Department of Medicine and Oncology, "Santa Maria della Scaletta" Hospital, via Montericco 4, 40026, Imola, Italy.

Gabriele Campana (G)

Department of Pharmacy and Biotechnology, Alma Mater Studiorum, University of Bologna, Bologna, Italy.

Classifications MeSH