Safety Analyses of Adalimumab in Patients With Rheumatoid Arthritis

The aim of this study was to assess the safety of adalimumab (Humira(R)) in global clinical trials and postmarketing surveillance among patients with rheumatoid arthritis (RA).

Researchers analysed safety data for adalimumab-treated patients from randomized controlled trials, open-label extensions, and two Phase IIIb open-label trials. In addition, researchers collected postmarketing spontaneous reports of adverse events in the United States (US) following Food and Drug Administration approval of adalimumab on December 31, 2002.As of April 15, 2005, the RA clinical trial safety database analyzed covered 10,050 patients, representing 12,506 patient-years (PYs) of adalimumab exposure. The rate of serious infections, 5.1/100-PYs, was comparable to that reported on August 31, 2002 (4.9/100-PYs), and to published reports of RA populations naive to anti-tumor necrosis factor (TNF) therapy. With the implementation of tuberculosis (TB) screening in clinical trials, the rate of TB decreased. There were 34 cases of TB as of this analysis (0.27/100-PYs). The standardized incidence ratio for lymphoma was 3.19 (95% CI=1.78-5.26) based on the Surveillance, Epidemiology and End Results cancer database. This is consistent with the observed increased incidence in the general RA population. As of June 30, 2005, there were an estimated 78,522 PYs of exposure to adalimumab in the US postmarketing period. Seventeen TB cases were spontaneously reported (0.02/100-PYs) from the US. Rates of other postmarketing events of interest – such as congestive heart failure, systemic lupus erythematosus, opportunistic infections, blood dyscrasias, lymphomas, and demyelinating disease – support observations from clinical trials. Researchers concluded that analyses of these data demonstrate that long-term adalimumab treatment is generally safe and well-tolerated in patients with RA.(Source: PMID: 16439435 [PubMed – as supplied by publisher]: February 2006.)