Long-Term Adalimumab (Humira) Safe for Rheumatoid Arthritis Patients

NEW YORK (Reuters Health) Jul 10 - Long-term treatment of rheumatoid arthritis (RA) with adalimumab is generally safe and well tolerated, according to a report in the July issue of the Annals of the Rheumatic Diseases.
More than one million patients have been treated with tumor necrosis factor antagonists, including adalimumab, the authors explain, but safety concerns persist.
Dr. Michael H. Schiff from Denver Arthritis Clinic and colleagues analyzed safety data collected from adalimumab's early clinical trials in 1997 through 2005.
The rate of serious infections in the clinical trial safety database was 5.1 per 100 patient-years, the authors report, which "is similar to rates reported for the general RA population."
Since the initiation of tuberculosis screening, there have been 23 cases in Europe (0.33 cases/100 patient-years) and 4 cases in North America (0.08 cases/100 patient-years).
The rates of lymphoma after adalimumab exposure (0.21 cases/100 patient-years) were consistent with those reported for RA populations nave to anti-TNF therapy, the researchers note.
Rates of demyelinating disorders, systemic lupus erythematosus, and congestive heart failure have also been low in patients taking adalimumab, the report indicates.
"Analyses of safety data from adalimumab global clinical trials and US postmarketing reports show that adalimumab therapy is generally safe and well tolerated in patients with RA," the authors write.
The relatively low rates of these serious adverse adalimumab-associated events "do not appear to outweigh the substantial clinical benefits adalimumab offers the RA population," they conclude.
Ann Rheum Dis 2006;65:889-894.

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by rlp

This report is welcomed news regarding the long term safety of Adalimumab. As with any new therapy, once the medication is prescribed to the public at large new side effects may be identified that were not during the clinical studies. Such was the case when Etanercept (Enbrel) and Infliximab (Remicade) were approved. After the therapies were prescribed on a large scale, cases of severe Tuberculosis associated with these drugs were reported. In the case of Adalimumab, no surprises so far identified. There is now increase in comfort level for Adalimumbab.