News Highlights from the ACR
Reporting by Kenna Simmons, Denise Lynn Mann and Mary Anne Dunkin
The American College of Rheumatology held its 71st Annual Scientific Meeting November 6 through 11 at the Boston Convention Center, and Arthritis Today had an on-site team there to you bring you the news. Following are some highlights of the meeting.
Fish Oils May Be Beneficial for Lupus
Omega-3 fish oils may benefit lupus activity as well the cardiovascular effects of the disease, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Boston, Mass.
Researchers randomly assigned 60 patients with lupus in a double-blind, placebo controlled trial to determine the effect of dietary supplementation with omega-3 polyunsaturated fatty acids on disease activity and endothelial function. They employed various methods to measure lupus disease activity and to study endothelial function and cell damaging free radical molecules in this 24-week study.
At the end of the study, participants who had been taking omega-3 fish oil showed significant improvement in all areas of measurement, including improved blood vessel function and a reduction in cell damaging molecules—resulting in potential cardiovascular benefits. There was also a significant improvement in a number of the symptoms of active lupus.
“Previous studies of lupus suggested a benefit in disease progression and symptoms, [but] this is the first study to show improvement in blood vessels from fish oil,” said lead investigator Stephen Wright, MD, of Queen’s University of Belfast, Northern Ireland.
He said it was interesting that there was also an improvement in symptoms such as fatigue headache, joint pain, because these are the symptoms that are hardest to treat. Although the study isn't enough to make a recommendation – and he noted that he doesn’t think fish oil will have an effect on other symptoms, like kidney involvement – it makes sense for people to ask their doctors about low-dose fish oil. 11/10/07
Low Vitamin D Levels Linked to Increased Osteoarthritis Pain
In a study of 100 men and women with signs of knee osteoarthritis (OA), researchers at Tufts New England Medical Center in Boston found that 47 percent were deficient in vitamin D and that this deficiency contributed to problems with pain and mobility. “People with lower levels of vitamin D were three times more likely to report more pain and have a harder time on the walk test,” said Tim McAlindon, M.D., associate professor of medicine at Tufts and an investigator in the study.
The body normally manufactures most of its vitamin D in response to sunlight. The vitamin is available to a lesser extent in dietary sources such as margarine, oily fish, liver, fortified breakfast cereals and dairy products. Elderly people’s bodies, however, are less efficient at absorbing vitamin D and converting it to is active form. For this reason, vitamin D supplements are often recommended to prevent osteoporosis. The results of this study suggest that vitamin D supplements may also help in arthritis treatment.
“This is an observational study so we need to wait for data from clinical trials before making any recommendations,” said Dr. McAlindon, who presented the research results at the American College of Rheumatology’s Annual Scientific Meeting. In the meantime people who are concerned can about vitamin D deficiency should speak with their doctors. 11/10/07
GI Complications from NSAIDs Rising
As the use of selective COX-2 blockers fell from grace due to studies linking these drugs to increased risk of heart attack and stroke, many people with arthritis once again turned to traditional nonsteroidal anti-inflammatory drugs (NSAIDs) to alleviate their joint pain and inflammation. Now new research presented this week at the annual meeting of the
While the gastroprotection gap (the amount of people not protecting their stomachs when taking traditional NSAIDs) had been declining steadily over the last decade, it more than doubled in 2005 when the second COX-2 inhibitor, valdecoxib (Bextra), was pulled from the market. What's more, there was a corresponding 2 percent increase in serious GI complications in 2005. The COX-2 blockers were designed to be safer than traditional NSAIDs for the stomach.
Calling this “a public health disaster and an emergency,” lead researcher Gurkirpal Singh, MD, an adjunct clinical professor of medicine in the division of gastroenterology and hepatology at Stanford University School of Medicine told Arthritis Today that “NSAIDs still carry a significant risk of serious gastrointestinal bleeds and this cannot be ignored.”
Botox Injection May Improve Joint Pain and Function
Botox injections can do more than make your skin look younger. A new study shows a single injection of Botox (botulinum neurotoxin Type A) into the joint may significantly decrease pain and improve function in arthritic shoulders.
Forty-three patients with moderate to severe shoulder pain due to arthritis were randomly placed in two groups and assessed at one, three and six months. The first group received intraarticular neurotoxin and lidocaine, while the second group received saline and lidocaine.
By comparing pain levels before beginning treatment to pain levels 28 days after the treatment, researchers found that pain levels were significantly lower in the patients receiving neurotoxin compared to placebo. Thirty-eight percent of patients receiving the injection of botulinum neurotoxin into the joint had at least a 30 percent reduction in pain score compared to only nine percent of patients in the placebo group. There was also a trend toward a greater improvement in shoulder function in the botulinum toxin group, as compared to the placebo group at 28 days.
Rheumatoid Arthritis May Increase Stroke Risk
Having rheumatoid arthritis (RA) may increase your risk of stroke, according to research presented Thursday at the American College of Rheumatology (ACR) Annual Scientific Meeting.
To investigate the incidence of stroke and its important risk factors in RA, researchers compared the general population to patients with RA, using the United Kingdom General Practice Research Database, which contains medical records of over seven million patients.
After analyzing 33,191 patients with RA and 99,570 patients without RA as controls, researchers found 883 cases of stroke in patients with RA, which was about 65 percent higher than expected in persons who did not have RA. When considering multiple variables – including age, sex, body mass index, smoking, other risk factors, and the use of arthritis medications – RA continued to be associated with a significantly higher risk of stroke.
RA is known to be associated with an increased risk of myocardial infarction. These unique data suggest that the disease is associated with an increased risk of stroke as well, says lead study author Christopher J Edwards, M.D. of Southampton General Hospital in the United Kingdom. “Appropriate risk assessment and intervention for this important cause of morbidity and mortality in rheumatoid arthritis is clearly a critical issue," he says. 11/9/07
Obesity Can Reduce Chance of Rheumatoid Arthritis Remission
When it comes to arthritis, being overweight can do more than increase your risk of osteoarthritis and place excessive strain on affected joints. New research presented the American College of Rheumatology (ACR) Annual Scientific Meeting shows it can also decrease the chances of rheumatoid arthritis (RA) going into remission.
To determine if body mass index (BMI, a calculation based on body fat, height and weight) can contribute to the remission of RA, researchers randomly placed 100 participants of different BMIs on either combination therapy consisting of methotrexate, sulfasalazine, hydroxychloroquine, prednisolone and either placebo or infliximab.
After 12 months of treatment, 58 percent of patients with normal body weight on placebo plus combination therapy were in remission, compared to only 35 percent of those who were overweight (BMI of 25 to 29.9) and 25 percent of those who were clinically obese (BMI of 30 or greater). However, the effect of being overweight on ability to achieve remission was not apparent in patients taking combination therapy and infliximab.
While obesity induces resistance to conventional antirheumatic drugs, infliximab overcomes this resistance probably due to its direct effect on inflammatory mediator, says Marjatta Leirisalo-Repo, MD, PhD, of
Methotrexate-TNF Inhibitor Combination Reduces Heart Attack Risk in Rheumatoid Arthritis
Taking a tumor necrosis factor (TNF) inhibitor in combination with methotrexate to control your rheumatoid arthritis (RA) may have the added benefit of protecting your heart, according to new research presented at the American College of Rheumatology (ACR) Annual Scientific Meeting.
In the study, researchers examined the risk of heart attack in a population of 19,233 RA patients using one or a combination of three types of medications: a TNF-inhibitor, methotrexate and other disease-modifying antirheumatic drugs (DMARDs). Many were also taking aspirin.
The researchers found that patients on a combination of TNF-inhibitors with methotrexate treatment had a heart attack risk of only 20 percent of the risk compared to patients taking methotrexate alone.
However, there was no statistical difference seen among patients who were taking TNF-inhibitors alone, TNF-inhibitors with other DMARDs, other DMARD therapies without methotrexate, or a combination of DMARDs and methotrexate.
“TNF-inhibitor therapy, in combination with methotrexate, dramatically reduces the risk of heart attacks in patients with RA and should be seriously considered— especially in high-risk patients,” said
Biologics’ Benefits Shown in Children
Studies of the biologic response modifiers, which are approved for and becoming staples of treatment for adults with moderate to severe RA, are increasingly demonstrating their safety and effectiveness in children with juvenile arthritis. The following are some highlights of those studies:
Etanercept (Enbrel)
Etanercept (Enbrel), a biologic agent that blocks tumor necrosis factor (TNF, a protein produced in the body that causes the pain and tenderness associated with rheumatic disease) is safe in the long-term treatment of juvenile rheumatoid arthritis (JRA), according to a new study presented at this week’s American College of Rheumatology (ACR) meeting.
The study was an extension of a double-blind, randomized controlled trial of etanercept in 69 children with JRA. Eighty-four percent of the children continued on to the open extension and researchers assessed safety and effectiveness using a variety of validated assessment tools in those patients who received at least one dose of etanercept during the extension.
A total of 42 patients continued taking etanercept for four years, and 26 continued for eight years. Twenty-three percent of patients reported a total of 39 serious adverse events; however, the overall rate of serious adverse events did not increase with long-term exposure to the drug. In addition, no cases of lupus, demyelinating disorders, tuberculosis, malignancies, lymphomas, or deaths were reported.
According to study author Andreas Reiff, MD, of the University of Southern California’s Keck School of medicine, the drug not only continued to be effective long term, but it also had a “beneficial safety profile.” Only one serious infection – a kidney infection – was observed in the remaining patients during the past four years. 11/9/07
Abatacept (Orencia)
During a four-month open-label trial of the agent, 123 (65 percent) of the 190 children and adolescents enrolled were considered “responders,” defined as meeting the ACR Pediatric 30 (meaning at least a 30-percent improvement in disease) In those who had previously failed prior anti-tumor necrosis factor (TNF) therapy, 39 percent met the ACR Pediatric 30.
At the end of open-label trial, responders entered the second, blinded phase of the study and were randomized to either continue abatacept or receive placebo for up to six months, or until they met standardized definition for disease flare. Patients randomized to the placebo group compared to the abatacept group demonstrated disease flare much more frequently (53 percent vs. 20 percent, respectively) and quickly. An ACR Pediatric 90 response (meaning at least a 90-percent improvement in disease) was seen in 40 percent of those who received abatacept for the 10 months of the study. Adverse reactions were uncommon, but similar in the abatacept and placebo groups.
“Because of its unique mechanism of action, abatacept is an important new treatment approach for children with [juvenile arthritis],” said Daniel J. Lovell, M.D., professor of pediatrics at Cincinnati Children’s
Adalimumab (Humira)
In a similarly designed trial, children with with juvenile rheumatoid arthritis (JRA) experienced marked improvements in their disease and less frequent flares when being treated with adalimumab (Humira), a biologic agent that blocks tumor necrosis factor (TNF).
During an open-label period the 171 patients enrolled in the trial received adalimumab at a dose that was equivalent to the approved adult dose, but adjusted for the height and weight of a child. Those patients who responded then continued into a double-blind, placebo-controlled withdrawal study to confirm the efficacy of adalimumab treatment. During the study, efficacy and safety of the treatment were assessed at routine intervals.
After 16 weeks of adalimumab therapy, marked decreases in disease activity were observed: 77 percent of patients had a decrease of at least 50 percent in their disease symptoms, and 58 percent of patients had at least a 70 percent decrease in disease symptoms. After the 32-week, placebo-controlled period, patients receiving adalimumab had significantly fewer flares versus the placebo group, and had greater improvement in symptoms.
In an extension of the study, long-term efficacy was evaluated in patients who continued to receive adalimumab. The safety profile of adalimumab was favorable in the long-term treatment of JRA. Patients received substantial and sustained improvement during two years of treatment, even if they were not receiving concomitant methotrexate, an immunosuppressant commonly used to treat JRA. 11/9/07
