Adalimumab in Patients With RA and Over 5 Years of Therapy
Adalimumab in Patients With RA and Over 5 Years of Therapy
In a clinical practice setting, ADA was well tolerated, and no new safety concerns were identified during nearly 20,000 PYs of exposure. The incidence of SAEs and serious infections decreased with ongoing ADA treatment over 5 years. The incidences of deaths and malignancies were lower than expected for the general population, and the incidence of lymphoma was within expected rates for patients with RA. Clinical response to ADA, as measured by reduced disease activity and functional improvements, was maintained through more than 5 years of observation in patients with long-standing, severe RA. Safety and effectiveness observed in more than 6,600 RA patients over 5 years were consistent with results of randomised clinical trials of ADA.
Conclusions
In a clinical practice setting, ADA was well tolerated, and no new safety concerns were identified during nearly 20,000 PYs of exposure. The incidence of SAEs and serious infections decreased with ongoing ADA treatment over 5 years. The incidences of deaths and malignancies were lower than expected for the general population, and the incidence of lymphoma was within expected rates for patients with RA. Clinical response to ADA, as measured by reduced disease activity and functional improvements, was maintained through more than 5 years of observation in patients with long-standing, severe RA. Safety and effectiveness observed in more than 6,600 RA patients over 5 years were consistent with results of randomised clinical trials of ADA.
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