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.

----------
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.

NOF Scientific Statement on Osteonecrosis of the Jaw and Bisphosphonates

Osteonecrosis of the Jaw (ONJ)
June 14, 2006


What is it?

Recently reports have described a dental condition, ONJ, in which bone in the lower jaw or less commonly the upper jaw becomes exposed, typically after a dental extraction or some other trauma to the jaw, and the wound that occurs fails to heal in the usual time frame. Infection in the area can occur and the area may be painful. This can become a chronic problem in many of those who develop it. With careful dental management, use of antibiotics and daily rinsing of the mouth with antibiotic solutions some patients with the condition do experience healing over time.

Current information suggests that this condition appears to occur infrequently in patients with cancer and rarely in patients with benign conditions such as osteoporosis or Paget’s disease of bone who are being treated with bisphosphonate medications.

Of the cases reported to date, nearly 95% were cancer patients receiving an intravenous bisphosphonate, pamidronate (Aredia®) or zoledronate (Zometa®), typically given every three to four weeks. A very small number of patients being treated with the bisphosphonate pills alendronate (Fosamax®) or risedronate (Actonel®) for osteoporosis prevention or treatment have also been reported to have developed ONJ. Fosamax® and Actonel® have been available in the U.S. since 1995 and 1998, respectively, and have been used safely by many millions of patients.

Last year the U.S. Food and Drug Administration (FDA) decided that a statement about ONJ would be required in the safety information provided in the package inserts of all bisphosphonate products so that doctors and patients would have this information.


What are points to consider?

Whenever a medication is prescribed, it is important for the patient to understand both the benefits and the potential risks or side effects associated with that medication.

Fosamax® and Actonel® were approved by the FDA for use in the prevention and treatment of osteoporosis after extensive clinical studies found them to be generally well tolerated and effective in reducing bone loss to prevent osteoporosis and in reducing the likelihood of fractures in patients with osteoporosis.

Based on information available to date, the incidence of ONJ appears to be rare in people taking oral bisphosphonates. It is important however, that patients taking bisphosphonates continue to get regular dental check-ups and to let their dentist know about all the medications they take.

There are reports that some dentists are advising patients to stop the use of bisphosphonates for a period of time (e.g. a month or two) before and after a tooth extraction or implant surgery, but there is no clear evidence, at this time, as to whether this is necessary.


Summary

Based on the currently available information, NOF believes that the benefits of oral bisphosphonate medications outweigh the potential risk of ONJ in the vast majority of patients who are receiving them. Without these medications, patients for whom they are appropriate treatment would be at higher risk of fractures, and fractures are the source of significant pain and disability that impact on function and quality of life.



NOF encourages all osteoporosis patients taking oral bisphosphonates to discuss their individual situation with their doctor or other health care professional. As clinical information is still incomplete and the causes not fully understood, research into ONJ continues. As new information becomes available, NOF will be providing updates.



Reference:

Woo SB, Hellstein JW, Kalmar JR. Systematic review: bisphosphonates and osteonecrosis of the jaws. Annals of Internal Medicine. 2006 May 16;144(10):753-61.

http://www.nof.org/patientinfo/osteonecrosis.htm