There was a huge amount of groundbreaking research and news to choose from. So I have grouped my choices into categories, rather than a standard top ten list. These are my choices, including the ones I think are the most exciting, the hottest topics, or the most thought provoking.
New drugs in development
- In August, Pipex Pharmaceuticals, Inc. acquired dnaJP1, an oral, once-daily RA medication that is currently in clinical trials. DnaJP1 is a biologic drug, like Humira and Remicade that inhibits inflammation by reducing T-cells ability to produce tumor necrosis factor (TNF). The difference is that the oral form eliminates the need for injections and infusions. A Phase II clinical trial involving 160 rheumatoid arthritis patients showed progressive improvement in patients taking dnaJP1 and more patients succeeded on dnaJP1 compared to those taking placebo. In addition, improvement continued after treatment with dnaJP1 was discontinued. In addition, laboratory tests have found that oral dnaJP1 results in an 80% reduction in the production of tumor necrosis factor (TNF) by T-cells. Researchers are hopeful that oral dnaJP1 may be less toxic than the injectable biologics, meaning less likely to result in serious infections. They are also hopeful that the staying power of the drug within the body may mean that the drug rewires the immune system in a lasting way so the body does not attack itself causing inflammation.
- The maker of Actemra released clinical trial data this fall showing that the interleukin-6 inhibitor was able to slow structural joint damage by 85% after one year when combined with methotrexate. This was compared 67% when methotrexate alone. Actemra also improved physical function, and 47% of patients in the study achieved clinical remission, compared to an 8% remission rate found when patients take only methotrexate. In another international study of Actemra, more than 50% the patients receiving the drug achieved a 20% reduction in RA symptoms compared to just 26.5% who were taking the placebo plus methotrexate; and almost 44% of patients receiving the combination therapy reached at least a 50% reduction in symptoms compared to 10.8% of patients receiving placebo plus methotrexate.
Positive clinical trials for drugs already on the market. There were many clinical trials and studies completed regarding the safety and effectiveness of drugs that are already on the market. Some of the highlights include:
- UCB, the maker of Cimzia, released positive results from several Phase III clinical trials this year, finding that Cimzia is effective both when taken alone and in combination=2 0with methotrexate. Either way, the results showed that Cimzia can significantly reduce signs, symptoms and pain associated with RA, and improved physical function. The combination treatment trial showed rapid, lasting improvements in both physical function and pain when Cimzia was used in combination with methotrexate, with positive results within as little as one week of treatment. The trials also showed that Cimzia inhibits progression of long-term joint damage with results for up to one year after ending the course of medication.
- Results of a large clinical trial for Rituxan, involving 2,578 patients showed that twice as many patients with RA achieved clinical remission when given three successive courses of Rituxan in combination with methotrexate. Only 8.8% achieved clinical remission if methotrexate was the sole treatment. When comparing patients who were given three courses of Rituxan versus one course, twice as many achieved a 70% improvement in their symptoms and progression of joint damage over the period of two years was significantly reduced.
- One study of hydroxychloroquine found that people who take it to treat their RA symptoms are half as likely to develop diabetes as people who do not take it. This study built on previous research and could mean that physicians might consider prescribing it more often. Hydroxychloroquine has been used as a DMARD to treat rheumatoid arthritis for decades, though it was originally developed as an anti-malaria drug. Researchers think that since people with RA are at higher risk of developing diabetes, use of this drug alone or in combination with others might be beneficial both for treatment of RA and preventing diabetes in those at especially high risk.
- In September, scientists at Brigham and Women s Hospital and colleagues announced that they uncovered six specific locations on chromosomes (loci) linked to RA. Variations in the genetic sequence at these locations imply a risk of developing RA. They hope that the new discovery will help researchers determine how variations on these loci affect the immune system and will help focus future prevention and treatment on these areas. Previously, seven other loci had been linked to RA if variations occur.
Food and Drug Administration Actions in 2008
- In February, the FDA approved Humira to treat children 4 years and older with moderate to severe polyarticular juvenile idiopathic arthritis (JIA).
- In April, FDA also approved Orencia (abatacept) to treat children 6 years and older with moderate to severe polyarticular juvenile idiopathic arthritis (JIA).
- Then in June, FDA announced that it would be conducting a safety review of the TNF blockers (Enbrel, Humira and Remicade) for a possible association with development of lymphoma and other cancers in children and young adults.
- On September 04, 2008, the United States Food and Drug Administration (FDA) announced that those drug companies who manufacture the tumor necrosis factor (TNF) blocking drugs, Cimzia, Enbrel, Humira, and Remicade must add additional warnings to the packaging of the drugs in order to clearly disclose to patients the risk of developing severe fungal infections. While the fungal infections are very common, and most people's immune systems are able to fight them off naturally, several patients taking the immunosuppressant TNF agents have died from such invasive fungal infections, often because the infections were not recognized and treated early enough. The warnings are to inform patients and also to encourage physicians and health care workers to be able to recognize the signs and symptoms of fungal and bacterial infections earlier.
- Also in September, the FDA delayed the release of Actemra's, asking that Roche Holding, AG submit extra product manufacturing and product label information.
Obesity, Diabetes and RA linked
- In the U.S. the rates of obesity, diabetes and metabolic syndrome are increasing and this has a negative impact on those who suffer from rheumatoid arthritis. Several studies published this year have discussed the various impacts that these three conditions have on each other.
- One study of rheumatoid arthritis patients found that the risk of having moderate to high rheumatoid arthritis d disease activity was 9 times higher in those patients who also suffered from metabolic syndrome compared to those rheumatoid arthritis patients who did not have metabolic syndrome. Metabolic syndrome is a combination of conditions that can increase the risk of heart disease and diabetes, among other problems. Metabolic syndrome is characterized by abdominal obesity as well as elevated triglycerides, reduced HDL ("good") cholesterol, elevated blood pressure and elevated blood sugar
- Other studies have found that obesity can cause or be caused by RA. Obesity is a risk factor for both RA and cardiovascular disease. Both obesity and cardiovascular disease are associated with an increased risk of death. However, obesity does not only result from inactivity and unhealthy dietary habits. Obesity can also be caused by taking prednisone or TNF-inhibitors. Studies have also found that obese patients are less likely to respond to disease modifying drugs such as methotrexate.
- Studies published this year have differed on the link between RA and diabetes. Some believe20that inflammation due to RA may result in insulin resistance and the increased risk of developing Type 2 diabetes.
Smoking and Arthritis was a Hot Topic
- There have been several studies published this year and in the past few years linking smoking to a higher risk of developing RA. Studies have also found that smokers who developed RA are more likely to have a positive rheumatoid factor, a hallmark of more severe disease.
- Results of a newer study published this past fall found that cigarette smoking could exacerbate rheumatoid arthritis in Africans Americans who have recently been diagnosed with the inflammatory joint disease. Those who smoked were more likely to develop rheumatoid nodules. Rheumatoid nodules are growths under the skin and are often associated with more severe rheumatoid arthritis. The smokers also tended to have higher levels of certain rheumatoid factor auto-antibodies in the blood.
Another Continuing Hot Topic- RA and Heart attack risks
- There have been a multitude of studies over the last several years linking RA to an increased risk o f heart attack and strokes and an increased risk of death from those events. Researchers believe that the increased risk has to do with systemic inflammation of the blood vessels and tissues in the body related to the RA disease process.
- One study this year found that RA nearly doubles the risk of having a heart attack within the first 10 years of diagnosis. After adjusting for high blood pressure and diabetes, the Swedish researchers found that before their RA diagnosis, people were no more likely than others to have a heart attack. But after their diagnosis, their heart risks rose steadily.
- Another study from the Mayo Clinic found that the initial signs and symptoms of heart failure in people with RA are less obvious than in other patients even though people with RA have a higher death rate. The researchers believe that this may lead to difficulty with diagnosis and proper management both RA and cardiovascular health. They found that the 1-year mortality rate after heart failure in arthritis patients was 35 percent versus 19 percent in non-arthritis patients.
- Another study published in April found that men over age 50 with RA are at increased risk of suffering major cardiovascular events and that the level of RA disease activity predicts these events independent of traditional cardiovascular risk factors. They found that 54% of men with high disease activity had cardiovascular events, compared to 26% of those with low disease activity.
- On the positive side, a study in the UK found that people with RA may be able to reduce their high risk of heart attacks and strokes if they follow a gluten-free, vegan diet. The high fiber, low cholesterol nature of this lifestyle is believed to lower LDL (or the "bad") cholesterol and help decrease inflammation in the body. The dietary menu included nuts, sunflower seeds, fruit and vegetables, millet and corn and sesame milk for calcium. Saturated fats were not to make up more than 10% of daily energy intake, and wholegrain products were to be chosen as often as possible. The vegan participants also lowered their Body Mass Index (BMI).
- Also positive, in March, researchers published results of a study finding that people taking medications for RA may also be reducing their risk of heart attack and stroke in the process. They found that the time of exposure both to DMARDs and biological agents like TNF-inhibitors is associated with a reduction of the risk of cardiovascular events. For example, they determined that RA patients taking methotrexate for one year reduced their risk of heart attack by 18 percent and stroke by 11 percent.
Published On: January 02, 2009