Immunogenicity, safety and efficacy of abatacept administered subcutaneously with or without background methotrexate in patients with rheumatoid arthritis: Results from accompany, a phase III study.

Nash P, Nayiager S, Genovese MC, Kivitz AJ, Oelke K, Ludivico C, Palmer W, Rodriguez C, Delaet I, Elegbe A, Corbo M.
Journal   Arthritis Care Res.
Analytes Measured  
Matrix Tested   Serum
Year   2012
Page Numbers  
Application   Immunogenicity
OBJECTIVE: To evaluate the impact of concomitant methotrexate (MTX) on subcutaneous (SC) abatacept immunogenicity, and to assess safety and efficacy.

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

RESULTS: 96/100 enrolled patients completed the ST period; 3.9% (combination) and 4.1% (monotherapy) of patients 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% (monotherapy) of patients; 5.9% (combination) and 8.2% (monotherapy) of patients experienced SC injection reactions, all were mild in intensity. Mean (95% confidence interval [CI]) 28-joint Disease Activity Score (DAS28) change was -1.67 (-2.06, -1.28; combination) and -1.94 (-2.46, -1.42; monotherapy) at Month 4. Ninety patients entered and were treated in the LTE; 83.3% (75/90) remained ongoing at Month 24. One LTE-treated patient (1.1%) developed immunogenicity; 14.4% of patients experienced SAEs; no SC injection reactions were reported. For patients entering the LTE, mean (95% CI) DAS28 change from baseline was -1.84 (-2.23, -1.34; combination) and -2.86 (-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.

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