New Treatments for Rheumatoid Arthritis
The emergence of new drugs in the market gives RA sufferers more options, but there are also several challenges and risks linked to these drugs.
On May 20, 2006, The Wall Street Journal (WSJ) ran a story about the drug choices available to people with RA. Reporter David Hamilton reviews the growing number of drug options now available to treat RA and provide relief to sufferers. While the emergence of new drugs in the market gives RA sufferers more options, there are also several challenges and risks linked to these drugs. High costs, complicated administration of the the drugs and potenitally deadly side effects are issues patients must consider. To read the story, visit WSJ, 'New Treatments for Rheumatoid Arthritis.' You will need a subscription to read the article.
HealthCentral's RA expert, Dr. Borigini and Christine Miller, HealthCentral's Patient Expert, offer their opinions on the new and existing RA drugs.
Dr. Borigini, Rheumatologist
Up until the last several months, the three main biologic agents used in the treatment of rheumatoid arthritis have been tumor necrosis factor inhibiting drugs, including Humira, Enbrel and Remicade. But now these agents have some competition from Rituxan and Orencia–two biologics which have been on the market for only the last few months. Today I will discuss Rituxan, a medication which targets B lymphocytes.
B lymphocytes are cells of the adaptive immune system which express cell surface receptors which can cause cells to react against themselves if not for our immune system's ability to exhibit B cell tolerance. But if this tolerance fails, we produce antibodies against our own tissues, resulting in autoimmune disease, including rheumatoid arthritis.
Rheumatoid arthritis is associated with antibodies and if B cells could be removed, or at least disabled, the production of these auto-antibodies could be blocked, and perhaps the disease course altered.
Clinical trials with Rituxan–alone or in combination with either methotrexate or cytoxan showed a response after six months, similar to the response seen with the tumor necrosis factor inhibiting drugs. In fact, there was a persistent response seen after one year. Another study showed similar promising results. There have been no major safety concerns during the follow up of these study patients. In particular, we have not seen recurrent infections with Rituxan use; however, since it is fairly new on the market, both doctor and patient must watch for any ill effects as the use of the drug continues in the general rheumatoid arthritis population.
Additionally, more studies must be done to determine which traditional rheumatoid arthritis treatments (for example, methotrexate) are most effective in combination with Rituxan.
The treatment of rheumatoid arthritis remains a challenge, but the continued research in novel ways of treating this illness continues to give physicians and patients hope that someday there will be an outright cure.
Christine Miller, RA Patient Expert:
Two new biotech drugs have been approved for the treatment of rheumatoid arthritis since December of 2005. Orencia and Rituxan are the newest options for patients with severe RA who are not responding to methotrexate and other TNF-inhibitors. Patients now are weighing the effectiveness of these new drugs against the risks of side effects and the expense. A June 20 article in the Wall Street Journal online discusses these drugs and other treatment options for patients suffering from RA.
Orencia, made by Bristol-Myers Squibb, was approved in December. It suppresses the immune system by inhibiting T-cells, a type of white blood cells that attack antibodies and foreign substances in the body. The typical course of treatment involves a visit to a clinic or doctor's office once every four weeks for a 30-minute infusion. Patients often use this drug in combination with methotrexate.
Rituxan, sold by Genentech, Inc. and Biogen Idec, Inc, was approved for the treatment of RA in February. It was originally developed and marketed as treatment for non-Hodgkin's lymphoma, a type of blood cancer. Rituxan kills B-cells, white blood cell made in the bone marrow that releases antibodies in an immune system response. The typical course of treatment is two infusions, lasting for 3-6 hours, spaced two weeks apart.
Patients who take these drugs have the potential for lasting relief from pain, inflammation, and joint damage. However, there are downsides to these drugs, similar to the other biotech drugs. These drugs have the same logistical inconvenience of some TNF-inhibitors because they both require office or clinic visits for administration of the drugs. But to many patients, this may be the least burdensome of the considerations.
While both of these drugs seem to be effective so far, they are extremely expensive, even for insured patients. Orencia costs in the range of $17,500 a year for patients without insurance. Rituxan is even more expensive, costing about $18, 630 for the course of two infusions. This is similar to the family of TNF-inhibitors, which also cost similar amounts ranging from approximately $11,000 to $28,000 a year. Most insurance companies cover these drugs when other treatments have failed, but some require co-payments of as much as 20%. This can create a financial hardship for some patients.
In addition, Orencia and Rituxan have been linked to serious and sometimes fatal side effects such as deadly infusion reactions and an increased risk of cancer. This is also similar to the TNF-inhibitors which some studies have shown patients to be twice as likely to develop serious infections and three times as likely to develop various types of cancers, such as lymphoma and breast, lung, and skin cancers.
While I am excited about the potential these drugs have to bring relief and daily function to so many people, I continue to have the same reservations that I have previously expressed about biotech drugs. First, I am concerned about the potential side effects of these drugs and whether all side effects have been studied. While the government has high standards and requirements for clinical trials, recent developments like the Vioxx trials have shown weaknesses in the system. There is a definite financial incentive to having favorable research. These companies have spent millions of dollars and many years developing these treatments. Drug companies are for-profit companies, beholden to shareholders and they have a great impact on the health care market and the overall economy. I hope that there will be continued funding of longitudinal studies of the effectiveness and risks of side effects of these drugs.
Second, other recent articles have shown the skyrocketing costs and expenditures by insurance companies. Drug companies recoup their investments and make their profit by charging very large sums for the drugs. While insurance covers most of the cost, I will be interested to find out how and to what degree the exponential increase in health plan spending for biotech drugs will be passed on to consumers through our premiums and other cost-sharing methods. On the other hand, these drugs have lasting benefits for many patients, virtually stopping disease progression. So in the long run, this saves insurance companies and consumers by staving off disability and the long-term costs of chronic care. Insurance companies, Medicare & Medicaid and consumers may end up paying less over the years for medical and other health services like therapy and for adaptive equipment, nursing assistance and home health care.