FDA OKs New Rheumatoid Arthritis Drug
Orencia Is for Patients Not Adequately Helped by Other RA Drugs
Dec. 27, 2005 -- The FDA has approved Orencia, a member of a new class of drugs for treating rheumatoid arthritis (RA).
The announcement comes from Orencia's maker, Bristol-Myers Squibb Company.
Orencia is to be used to reduce RA's signs and symptoms in patients not helped by other RA drugs, according to a Bristol-Myers Squibb news release.
Orencia was studied in adults with RA who had an unsuccessful response to other RA drugs.
Specifically, the patients had tried methotrexate and biologic drugs such as anti-TNF drugs that target an inflammatory protein called TNF (tumor necrosis factor). Those medications are collectively called DMARDs (disease-modifying antirheumatic drugs).
In clinical trials, some patients got Orencia. Others got a fake drug (placebo). Some also got DMARDs.
Those who got Orencia had significantly greater improvement in RA's signs and symptoms, including a slowdown in damage to the joints, the news release states.
The most common adverse events seen in patients taking Orencia were headache, infection of the upper respiratory tract, and nausea.
Serious infections were rare but more common with patients taking Orencia than the placebo.
Infections (some of which were serious) were also more common in patients taking Orencia and anti-TNF drugs than among those who only took anti-TNF drugs.
Also, respiratory problems (such as cough) were more common in patients taking Orencia who also had chronic obstructive pulmonary disease (COPD).
Overall, cancers weren't more common in patients taking Orencia than the placebo. However, lung cancer was seen in slightly more of those taking Orencia than the placebo (0.2% of Orencia patients and none of the placebo patients).
Lymphoma was also more common with Orencia than among the general public.
"However, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma," states Bristol-Myers Squibb. "The potential role of Orencia in the development of malignancies in humans is unknown."
Orencia may be taken alone or with DMARDs other than anti-TNF drugs and Kineret (anakinra), states Bristol-Myers Squibb.
The news release also includes these other safety notes:
- Patients shouldn't get live vaccines while taking Orencia or within three months of stopping the drug.
- Caution should be used in prescribing Orencia for patients with chronic obstructive pulmonary disease (COPD). Those patients' respiratory health should be monitored.
- Orencia should be used during pregnancy only if clearly needed. Studies with rats have not determined whether there is a risk to the human fetus during pregnancy.
- Nursing mothers should talk to their doctors about the risks and benefits of taking Orencia.