Immunogenicity, safety, and efficacy of abatacept administered subcutaneously with or without background methotrexate in patients with rheumatoid arthritis: results from a phase III, international, multicenter, parallel-arm, open-label studyy

Nash, Peter, Nayiager, Sauithree, Genovese, Mark C., Kivitz, Alan J., Oelke, Kurt, Ludivico, Charles, Palmer, William, Rodriguez, Cristian, Delaet, Ingrid, Elegbe, Ayanbola and Corbo, Michael (2013) Immunogenicity, safety, and efficacy of abatacept administered subcutaneously with or without background methotrexate in patients with rheumatoid arthritis: results from a phase III, international, multicenter, parallel-arm, open-label studyy. Arthritis Care and Research, 65 5: 718-728. doi:10.1002/acr.21876


Author Nash, Peter
Nayiager, Sauithree
Genovese, Mark C.
Kivitz, Alan J.
Oelke, Kurt
Ludivico, Charles
Palmer, William
Rodriguez, Cristian
Delaet, Ingrid
Elegbe, Ayanbola
Corbo, Michael
Title Immunogenicity, safety, and efficacy of abatacept administered subcutaneously with or without background methotrexate in patients with rheumatoid arthritis: results from a phase III, international, multicenter, parallel-arm, open-label studyy
Journal name Arthritis Care and Research   Check publisher's open access policy
ISSN 2151-464X
2151-4658
Publication date 2013-05
Year available 2013
Sub-type Article (original research)
DOI 10.1002/acr.21876
Volume 65
Issue 5
Start page 718
End page 728
Total pages 11
Place of publication Hoboken, NJ, United States
Publisher John Wiley & Sons
Collection year 2014
Language eng
Formatted abstract
Objective: To evaluate the impact of concomitant methotrexate (MTX) on subcutaneous (SC) abatacept immunogenicity, and to assess safety and efficacy.

Methods: This phase III, open-label study had a 4-month short-term (ST) period and an ongoing long-term extension (LTE) period. Rheumatoid arthritis patients were stratified to receive SC abatacept (125 mg/week) with (combination) or without MTX (monotherapy), with no intravenous loading dose; patients receiving monotherapy could add MTX in the LTE period. Immunogenicity (percentage of anti-abatacept antibody–positive patients) was assessed. ST and LTE period data are reported, including efficacy through LTE month 14 and safety through LTE month 20.

Results: Ninety-six of 100 enrolled patients completed the ST period; 3.9% (combination) and 4.1% of patients (monotherapy) developed transient immunogenicity, and no patients were antibody positive at month 4. Serious adverse events (SAEs) were reported in 3.9% (combination) and 6.1% of patients (monotherapy); 5.9% (combination) and 8.2% of patients (monotherapy) experienced SC injection reactions, and all were mild in intensity. Mean 28-joint Disease Activity Score (DAS28) changes were −1.67 (95% confidence interval [95% CI] −2.06, −1.28; combination) and −1.94 (95% CI −2.46, −1.42; monotherapy) at month 4. Ninety patients entered and were treated in the LTE period; 83.3% (75 of 90) remained ongoing at month 24. One LTE-treated patient (1.1%) developed immunogenicity, 14.4% of patients experienced SAEs, and no SC injection reactions were reported. For patients entering the LTE period, mean DAS28 changes from baseline were −1.84 (95% CI −2.23, −1.34; combination) and −2.86 (95% CI −3.46, −2.27; monotherapy) at month 18.

Conclusion: SC abatacept did not elicit immunogenicity associated with loss of safety or efficacy, either with or without MTX.
Keyword Costimulation modulator abatacept
Disease activity
Inadequate response
Revised criteria
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
School of Medicine Publications
 
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