Long-term data from the ACQUIRE trial: subcutaneous Abatacept for the treatment of rheumatoid arthritis
The aim of a study was to assess long-term tolerability, safety, and efficacy of subcutaneous ( SC ) Abatacept ( Orencia ) in Methotrexate-refractory patients with rheumatoid arthritis.
The phase III ACQUIRE trial ( Abatacept Comparison of Sub[QU]cutaneous Versus Intravenous in Inadequate Responders to MethotrexatE ) comprised a 6-month, randomized, double-blind period, in which patients received intravenous ( IV ) or SC Abatacept, plus Methotrexate, followed by an open-label, long-term extension ( LTE ), in which patients received subcutaneous Abatacept, 125 mg/week.
Safety and efficacy from the LTE ( 3.5 years of exposure ) are reported.
Patients who completed the double-blind period ( 1372/1385, 99.1% ) entered the long-term extension; 1134 patients ( 82.7% ) kept taking the treatment at time of reporting.
Mean was 31.9 months; median exposure was 33.0 months. Patients entering the long-term extension had longstanding, moderate-to-severe disease [ mean 7.6 yrs and DAS28 ( C-reactive protein ) 6.2 ( 0.9 ) ].
Incidence rates ( events/100 patient-yrs ) were reported for serious adverse events ( 8.76, 95% CI 7.71, 9.95 ), infections ( 44.80, 95% CI 41.76, 48.01 ), serious infections ( 1.72, 95% CI 1.30, 2.27 ), malignancies ( 1.19, 95% CI 0.86, 1.66 ), and autoimmune events ( 1.31, 95% CI 0.95, 1.79 ).
Twenty-seven patients ( 2% ) experienced injection-site reactions; all except 1 were mild.
American College of Rheumatology 20, 50, and 70 responses achieved during the double-blind period were maintained through the long-term extension, and on Day 981 were 80.2% ( 95% CI 77.2, 83.2 ), 63.5% ( 95% CI 58.2, 68.9 ), and 39.5% ( 95% CI 34.0, 44.9 ) for patients who kept taking subcutaneous Abatacept, and 80.0% ( 95% CI 77.0, 83.0 ), 63.2% ( 95% CI 57.8, 68.7 ), and 39.2% ( 95% CI 33.7, 44.7 ) for those who switched from intravenous to subcutaneous Abatacept.
In conclusion, these findings support subcutaneous Abatacept as a well-tolerated and efficacious long-term treatment for patients with rheumatoid arthritis and inadequate response to Methotrexate. ( Xagena )
Genovese MC et al, J Rheumatol 2014; 41: 629-639
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