https://doi.org/10.4081/reumatismo.2023.1602

Anti-tumor necrosis factor α: originators versus biosimilars, comparison in clinical response assessment in a multicenter cohort of patients with inflammatory arthropathies

Vol. 75 No. 4 (2023)
Submitted: 16 June 2023
Accepted: 25 September 2023
Published: 19 December 2023
Biosimilars, bioriginators, anti-TNF, inflammatory arthropathies
Abstract Views: 1551
PDF: 349
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Authors

C. Gioia
https://orcid.org/0000-0003-3559-2571
Division of Rheumatology, Department of Clinical Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University, Rome, Italy.
A. Picchianti Diamanti
Rheumatology, Clinical and Molecular Medicine, Sapienza University, Sant’Andrea University Hospital, Rome, Italy.
R. Perricone
Rheumatology, Allergology and Clinical Immunology, Department of Systems Medicine, Tor Vergata University, Rome, Italy.
M.S. Chimenti
https://orcid.org/0000-0002-1343-1729
Rheumatology, Allergology and Clinical Immunology, Department of Systems Medicine, Tor Vergata University, Rome, Italy.
A. Afeltra
Allergology, Clinical Immunology and Rheumatology, Bio-Medical Campus, University of Rome, Italy.
L. Navarini
Allergology, Clinical Immunology and Rheumatology, Bio-Medical Campus, University of Rome, Italy.
A. Migliore
https://orcid.org/0000-0002-3397-6478
San Pietro Fatebenefratelli Hospital, Rome, Italy.
U. Massafra
San Pietro Fatebenefratelli Hospital, Rome, Italy.
V. Bruzzese
Department of Internal Medicine, Rheumatology and Gastroenterology, Nuovo Regina Margherita Hospital, Rome, Italy.
P. Scolieri
Department of Internal Medicine, Rheumatology and Gastroenterology, Nuovo Regina Margherita Hospital, Rome, Italy.
C. Meschini
General Medicine, Belcolle Hospital, Viterbo, Italy.
M. Paroli
https://orcid.org/0000-0001-7919-9128
Department of Medical-Surgical Sciences and Biotechnology, Polo Pontino, Sapienza University, Latina, Italy.
R. Caccavale
Department of Medical-Surgical Sciences and Biotechnology, Polo Pontino, Sapienza University, Latina, Italy.
P. Scapato
Rheumatology, Department of Medicine, S. Camillo de Lellis Hospital, Rieti, Italy.
R. Scrivo
https://orcid.org/0000-0002-2889-8962
Division of Rheumatology, Department of Clinical Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University, Rome, Italy.
F. Conti
https://orcid.org/0000-0002-1897-049X
Division of Rheumatology, Department of Clinical Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University, Rome, Italy.
B. Laganà
Rheumatology, Clinical and Molecular Medicine, Sapienza University, Sant’Andrea University Hospital, Rome, Italy.
M. Di Franco
manuela.difranco@uniroma1.it
Division of Rheumatology, Department of Clinical Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University, Rome, Italy.

Objective. To compare etanercept and adalimumab biosimilars (SB4 and ABP501) and respective bioriginators in terms of safety and efficacy in a real-life contest.

Methods. We consequently enrolled patients affected by rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, treated with SB4, and ABP501, or with corresponding originators, belonging to the main biological prescribing centers in the Lazio region (Italy), from 2017 to 2020. Data were collected at recruitment and after 4, 8, 12, and 24 months of therapy.

Results. The multicenter cohort was composed by 455 patients treated with biosimilars [SB4/ABP501 276/179; female/male 307/146; biologic disease-modifying anti-rheumatic drug (b-DMARD) naïve 56%, median age/ interquartile range 55/46-65 years] and 436 treated with originators (etanercept/adalimumab 186/259, female/ male 279/157, b-DMARD naïve 67,2%, median age/interquartile range 53/43-62 years). No differences were found about safety, but the biosimilar group presented more discontinuations due to inefficacy (p<0.001). Female gender, being a smoker, and being b-DMARD naïve were predictive factors of reduced drug survival (p=0.05, p=0.046, p=0.001 respectively). The retention rate at 24 months was 81.1% for bioriginators and 76.5% for biosimilars (median retention time of 20.7 and 18.9 months, respectively) (p=0.002). Patients with remission/low disease activity achievement at 4 months showed a cumulative survival of 90% to biosimilar therapy until 24 months (p=0.001); early adverse reactions instead represented a cause of subsequent drug discontinuation (p=0.001).

Conclusions. Real-life data demonstrated a similar safety profile between biosimilars and originators, but a reduced biosimilar retention rate at 24 months. Biosimilars could be considered a valid, safe, and less expensive alternative to originators, allowing access to treatments for a wider patient population.

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A. Picchianti Diamanti, Rheumatology, Clinical and Molecular Medicine, Sapienza University, Sant’Andrea University Hospital, Rome

Assistant Professor in Rheumatology (RTDB), Clinical and Molecular Medicine, Sant'Andrea University Hospital, Sapienza University of Rome

R. Perricone, Rheumatology, Allergology and Clinical Immunology, Department of Systems Medicine, Tor Vergata University, Rome

† Prof. Roberto Perricone is deceased.

How to Cite

Gioia, C., Picchianti Diamanti, A. ., Perricone, R., Chimenti, M., Afeltra, A., Navarini, L., … Di Franco, M. . (2023). Anti-tumor necrosis factor α: originators <i>versus</i> biosimilars, comparison in clinical response assessment in a multicenter cohort of patients with inflammatory arthropathies. Reumatismo, 75(4). https://doi.org/10.4081/reumatismo.2023.1602
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