Subcutaneous abatacept versus intravenous abatacept: A phase IIIb noninferiority study in patients with an inadequate response to methotrexate

Genovese, M. C.; Covarrubias, A.; Leon, G.; Mysler, E.; Keiserman, M.; Valente, R.; Nash, P.; Simon‐Campos, J. A.; Porawska, W.; Box, J.; Legerton, C.; Nasonov, E.; Durez, P.; Aranda, R.; Pappu, R.; Delaet, I.; Teng, J.; Alten, R.

doi:10.1002/art.30463

Cited by 196Rheumatoid Arthritis Research and TherapiesAutoimmune and Inflammatory Disorders ResearchBiosimilars and Bioanalytical Methods

Subcutaneous abatacept versus intravenous abatacept: A phase IIIb noninferiority study in patients with an inadequate response to methotrexate

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Genovese, M. C., Covarrubias, A., Leon, G., Mysler, E., Keiserman, M., Valente, R., Nash, P., Simon‐Campos, J. A. +10 more·2011·Arthritis & Rheumatism

DOI 10.1002/art.30463PMC PMC3229984

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Abstract

OBJECTIVE: To compare the efficacy and safety of subcutaneous (SC) and intravenous (IV) abatacept. METHODS: In this phase IIIb double-blind, double-dummy, 6-month study, patients with rheumatoid arthritis (RA) and inadequate responses to methotrexate were randomized to receive 125 mg SC abatacept on days 1 and 8 and weekly thereafter (plus an IV loading dose [∼10 mg/kg] on day 1) or IV abatacept (∼10 mg/kg) on days 1, 15, and 29 and every 4 weeks thereafter. The primary end point for determining the noninferiority of SC abatacept to IV abatacept was the proportion of patients in each group meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at month 6. Other efficacy end points, immunogenicity, and safety were also assessed. RESULTS: Of 1,457 patients, 693 of 736 (94.2%) treated with SC abatacept and 676 of 721 (93.8%) treated with IV abatacept completed 6 months. At month 6, 76.0% (95% confidence interval 72.9, 79.2) of SC abatacept-treated patients versus 75.8% (95% confidence interval 72.6, 79.0) of IV abatacept-treated patients achieved an ACR20 response (estimated difference between groups 0.3% [95% confidence interval -4.2, 4.8]), confirming noninferiority of SC abatacept to IV abatacept. Onset and magnitude of ACR responses and disease activity and physical function improvements were comparable between the SC and IV abatacept-treated groups. The proportions of adverse events (AEs) and serious AEs over 6 months were 67.0% and 4.2%, respectively, in the SC abatacept-treated group and 65.2% and 4.9%, respectively, in the IV abatacept-treated group, with comparable frequencies of serious infections, malignancies, and autoimmune events between groups. SC injection site reactions (mostly mild) occurred in 19 SC abatacept (IV placebo)-treated patients (2.6%) and 18 IV abatacept (SC placebo)-treated patients (2.5%). Abatacept-induced antibodies occurred in 1.1% of SC abatacept-treated patients and 2.3% of IV abatacept-treated patients. CONCLUSION: SC abatacept provides efficacy and safety comparable with that of IV abatacept, with low immunogenicity and high retention rates, consistent with the established IV abatacept profile. Rates of injection site reactions were low. SC abatacept will provide additional treatment options, such as an alternative route of administration, for patients with RA.

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A lack of impact of ADAs on efficacy, safety, or pharmacokinetics was also described for abatacept or tocilizumab in rheumatoid arthritis.
“A lack of impact of ADAs on efficacy, safety, or pharmacokinetics was also described for abatacept or tocilizumab in RA [85, 86].”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [85]

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Authors: Genovese, M. C., Covarrubias, A., Leon, G., Mysler, E., Keiserman, M., Valente, R., Nash, P., Simon‐Campos, J. A., Porawska, W., Box, J., Legerton, C., Nasonov, E., Durez, P., Aranda, R., Pappu, R., Delaet, I., Teng, J., & Alten, R.
Affiliations: Stanford University (US)
Centro Nacional de Información de Ciencias Médicas (CU)
Instituto De Ginecologia Y Reproduccion, Lima, Peru
Organización Médica de Investigación, Buenos Aires, Argentina
Pontifícia Universidade Católica do Rio Grande do Sul (BR)
Physician Research Collaboration, Lincoln, Nebraska
The University of Queensland (AU)
Centro De Especialidades Médicas/HRAEPY, Merida, Mexico
Poznanski Osrodek Medyczny Novamed, Poznań, Poland
Box Arthritis and Rheumatology of the Carolinas, Charlotte, North Carolina
Low Country Rheumatology, Charleston, South Carolina
Association of Rheumatologists of Russia (RU)
Cliniques Universitaires Saint-Luc (BE)
Bristol-Myers Squibb (United States) (US)
Schlosspark-Klinik (DE)
Corresponding author: Genovese, M. C.
ORCID: Genovese, M. C.
Mysler, E.
Nash, P.
Box, J.
Nasonov, E.
Durez, P.
Alten, R.
Venue: Arthritis & Rheumatism
Publisher: Wiley
Published: 2011-09-27
Volume: 63
Issue: 10
Pages: 2854-2864
ISSN: 0004-3591 (ISSN-L)
1529-0131
DOI: 10.1002/art.30463
PMC: PMC3229984
OpenAlex: W2028514817
Cited by: 196
References: 26
Citations by year: 2026: 1 · 2025: 8 · 2024: 10 · 2023: 11 · 2022: 9 · 2021: 12 · 2020: 12 · 2019: 8 · 2018: 11 · 2017: 14 · 2016: 18 · 2015: 19 · 2014: 22 · 2013: 26 · 2012: 12
FWCI: 14.50
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
doi.wiley.com/10.1002/tdm_license_1.1 (tdm)
Locations: Arthritis & Rheumatism (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DIAL (Catholic University of Leuven) (submittedVersion)
Funders: Bristol-Myers Squibb
Topics: Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
Health Sciences › Medicine › Hematology › Autoimmune and Inflammatory Disorders Research
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Keywords: abatacept, subcutaneous administration, intravenous administration, rheumatoid arthritis, inadequate response to methotrexate, non-inferiority, ACR20 response, immunogenicity, adverse events, injection site reactions, disease activity, physical function, biologic therapy, treatment safety and efficacy comparison, serious infections, cancer
MeSH terms: Abatacept, Adult, Aged, Arthritis, Rheumatoid, Double-Blind Method, Female, Humans, Injections, Intravenous, Injections, Subcutaneous, Male, Methotrexate, Middle Aged, Treatment Outcome, Antirheumatic Agents, Immunoconjugates

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Subcutaneous abatacept versus intravenous abatacept: A phase IIIb noninferiority study in patients with an inadequate response to methotrexate

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