THURSDAY, March 20 (HealthDay News) -- The new anti-arthritis drug tocilizumab, now being tested, appears to be effective in relieving the symptoms of rheumatoid arthritis in both adults and children, according to the results of two new studies.

Tocilizumab works by blocking the interleukin-6 receptor. Interleukin-6 is a molecule involved in promoting the painful inflammation in rheumatoid arthritis.

The new findings are published in the March 22 issue of The Lancet.

However, one expert isn't convinced, especially for adults, that comparing tocilizumab to a placebo -- as was done in these studies -- proves that the drug is a better option than existing medications.

"It's not good enough to know if the new medication is working better than nothing," said Dr. Tim Bongartz, a rheumatologist at the Mayo Clinic College of Medicine and author of an accompanying editorial in the journal. "To answer the question of which of four or five [drug] options available I should choose, we need to know all the potential benefits and potential risks," he said.

In one study, led by Dr. Josef Smolen, of the division of rheumatology at the Medical University of Vienna, Austria, 623 people with moderate to severe rheumatoid arthritis were randomly assigned to receive tocilizumab or a placebo. In addition, the patients continued to receive the standard arthritis drug methotrexate.

The researchers found that after 24 weeks, 59 percent of the patients taking the highest dose of tocilizumab had at least a 20 percent improvement in symptoms of rheumatoid arthritis, compared with 26 percent of the patients receiving a placebo.

The most common serious side effects were severe infections among six patients receiving the highest dose of tocilizumab, according to the report.

The study was funded by drug makers F. Hoffman-La Roche and Chugai Pharmaceuticals, which together are developing tocilizumab.

"These data provide evidence that inhibition of interleukin-6-mediated pro-inflammatory effects significantly and rapidly improves the signs and symptoms of rheumatoid arthritis," Smolen's team wrote. "Thus, tocilizumab could be an effective agent for the treatment of patients with moderate to severe rheumatoid arthritis."

But Bongatrz countered that "it's no surprise that tocilizumab works better than nothing [placebo]. The question is, does it work better than the alternatives we already have available?"

In addition, there are potential problems with tocilizumab, Bongartz said. For one, this study didn't show whether the drug slows the progression of the disease. Also, the drug significantly increased patients' cholesterol levels, which Bongartz finds troubling.

In the second report, Japanese researchers, led by Dr. Shumpei Yokota, of the department of pediatrics at Yokohama City University School of Medicine, started 56 children, ages 2 to 19, on tocilizumab. These children all had systemic-onset juvenile idiopathic arthritis, which did not respond to the usual arthritis treatment. This is a common problem with this type of arthritis, the researchers noted.

After six weeks, children who had achieved a 30 percent reduction in their arthritis symptoms were randomly assigned to continue to receive tocilizumab or a placebo.

Of the 43 children in that phase of the study, 16 out of 20 who received tocilizumab continued the improvement they had made in the first phase of the trial, compared with only four of 23 children receiving a placebo, the researchers found.

During an additional 48 weeks in which 48 children continued to receive tocilizumab, 47 children achieved a 30 percent reduction in their symptoms, 45 children achieved a 50 percent reduction in their symptoms, and 43 children ultimately achieved a 70 percent reduction in their symptoms, according to the report.

Side effects included gastrointestinal bleeding, bronchitis, and gastroenteritis.

"The results of this placebo-controlled and open-label extension study with tocilizumab in children with systemic-onset juvenile idiopathic arthritis show a sustained clinical improvement and a favorable risk-benefit profile," the Japanese team wrote. "The findings of this study might represent a step forward in the control of a disease that has previously proved to be difficult to manage."

The study was funded by Chugai Pharmaceuticals.

Bongartz said tocilizumab may be worth a try with pediatric patients.

"The treatment options are pretty sparse, and children usually don't respond very well to methotrexate or other drugs, so here I think it's easier to decide in favor of initiating tocilizumab therapy," Bongartz said. "My threshold for initiating tocilizumab therapy would be lower, because I can't offer these children a lot of other choices."

New treatment options against rheumatoid arthritis are always welcome, Bongartz said. Still, he is cautious about using tocilizumab.

"It's another opportunity to offer treatment to patients who don't respond to first-, second- or third-line therapy, but I don't know if it works better than other established therapies. Based on the data available, it's almost impossible to make an informed decision about its benefits or potential harm," Bongartz said.

More information

For more on arthritis, visit the Arthritis Association  .

WEDNESDAY, March 19 (HealthDay News) -- In the latest research to cast a shadow on the safety of a popular bone-strengthening medication, researchers report that long-term use of Fosamax is associated with unusual fractures of the thigh bone.

The fractures were low-energy fractures, meaning that they all occurred from a fall from standing height or less, and the bone cracks were in an unusual horizontal pattern. About one-third of women with these types of fractures were on long-term therapy to prevent osteoporosis, the researchers noted. Of these women, two-thirds were taking Fosamax (alendronate), for an average of more than seven years.

Fosamax is a bisphosphonate, a class of drugs used to increase bone mass and reduce the risk of fracture in those who have osteoporosis.

"These were peculiar fractures that would occur when the women were basically doing nothing," said the study's senior author, Dr. Joseph Lane, chief of metabolic bone disease at the Hospital for Special Surgery at Weill Cornell Medical College in New York City.

Fifteen women were included in Lane's analysis. The average time on Fosamax was 5.4 years before they experienced the unusual femur fracture. Of these 15, 10 women had similar, atypical fractures. These women had been taking Fosamax for an average of 7.3 years, while the remaining five had only been on the drug for an average of 2.8 years.

"Our results provide further evidence of a potential link between alendronate use and low-energy fractures of the femur," the authors said in a letter reporting their findings, which is published in the March 20 issue of the New England Journal of Medicine. But, the authors acknowledge the limitations of their retrospective analysis and suggest that these findings need to be confirmed in a prospective study.

Lane said there are several theories as to how alendronate could be related to these fractures. One is that the drug slows down the development of new collagen, and he said new collagen is very strong. Another could be because there is slower bone turnover on the medications. That could mean there may be accumulated microdamage in the bone, making it more susceptible to fracture in certain women.

Lane said that women taking this medication should keep taking it, and these findings shouldn't cause them alarm. "This is a great drug that does wonderful things. Bisphosphonates have dropped the rate of hip fractures," he added.

Ron Rogers, a spokesman for Merck, which manufactures Fosamax, said, "Fosamax has not been associated with an increased risk of fracture at any skeletal site." Rogers also noted that this study didn't prove a cause and effect relationship between the drug and these unusual fractures, and that the researchers noted that 63 percent of women treated for low-energy fractures weren't taking bisphosphonates at all.

Dr. Loren Wissner Greene, co-director of the osteoporosis and metabolic bone disease program at the New York University School of Medicine, agreed that this study has just pointed out an association between Fosamax use and these fractures, not proven a causal relationship.

Still, Greene said she believes these atypical breaks probably are related to the medication, although she added, "If this is a related complication, it appears to be very rare."

Like Lane, she said, "Alendronate is still a very valuable drug in decreasing the risk of hip fracture." But, she said, what would be helpful is a test that could identify who is in the sub-population that might have a problem on this medication.

Lane said that women who've been taking this medication for a long time and have test results that suggest low bone turnover, may want to take a "bone holiday," and stop taking the medication for a year. But, he added, this shouldn't be done on your own. "If you've been on alendronate for a long time, talk to your doctor," he suggested.

The U.S. Food and Drug Administration in January issued an alert to physicians about the possibility of severe bone pain occurring as a result of bisphosphonate therapy. Additionally, last year Fosamax was also implicated in some cases of atrial fibrillation -- a serious type of irregular heartbeat -- though the FDA hasn't found evidence to support this association.

More information

Visit the National Library of Medicine to learn more about alendronate.

THURSDAY, March 6 (HealthDay News) -- Baby Boomers are staying active on the basketball court and soccer field, and now new research suggests their injured knees can tolerate surgery just as easily as their younger counterparts.

A new, but small, study found that men and women in their 50s and 60s did well after undergoing reconstruction of injured tissues in their knees known as anterior cruciate ligaments.

A couple decades ago, surgeons wouldn't have bothered to fix these injuries in people over 50, or even 40. Now, "you're never too old to have your ACL reconstructed," said Dr. Diane Dahm, an assistant professor of orthopedic surgery at the Mayo Clinic in Rochester, Minn.

She presented the research Wednesday at the American Academy of Orthopaedic Surgeons' annual meeting, in San Francisco.

The ACL is a kind of anchor that holds the knee together and can become injured when someone is playing sports and tries to turn and pivot, said Dr. Robert Gotlin, director of orthopedic and sports rehabilitation at Beth Israel Medical Center in New York City. Athletes who play sports like football, lacrosse, basketball and soccer are especially prone to the injury, he noted.

Tearing and extreme stretching hurt the ACL. According to Dahm, an injury could come while landing after a rebound on the basketball court. Injuries are also possible off the field, perhaps while changing direction quickly while getting out of a car. Still, she said, most of the injuries are related to sports.

In decades past, surgeons were reluctant to perform procedures on people who had injuries after the age of 40, because it was assumed that "your athletic life is done," Gotlin said. "You don't fix the ACL, because you don't really need it."

Times, and attitudes, have changed.

"Boomers are active, and they're tearing [their ACLs] for the right reasons, because they're working out," he noted. "They're getting hurt, because they're doing more."

As a result, older patients are going under the knife so they can stay active. Gotlin said he's performed surgeries on patients in their 80s who returned to the ski slopes, although rehabilitation can take months.

In the new study, researchers looked at the records of 34 patients who underwent ACL reconstruction surgery between 1990 and 2002 at the Mayo Clinic. All were between the ages of 50 and 66.

The surgery reconstructs the ACL with other tissue, sometimes from the patient's own body.

Eighty-three percent of the patients were considered to have returned to a normal or near-normal state after the surgery, and 83 percent returned to playing sports. However, five of the 34 patients required more knee surgery.

"Some people have felt that it's possible that reconstructing the ACL in these older patients might lead to an increased risk of complications like stiffness in the knee, but our complication rate was very low," Dahm said.

The message, she said, is that the surgery works: "They were able to return to a fairly high level of activity."

More information

Learn more about ACL injuries from the National Institutes of Health.

FRIDAY, Feb. 22 (HealthDay News) -- The U.S. Food and Drug Administration has approved Humira (adalimumab) to treat moderate-to-severe juvenile idiopathic arthritis (JIA) in children aged four years and older, maker Abbott Laboratories said Friday.

JIA -- often called juvenile rheumatoid arthritis -- can cause pain and permanent joint damage, making it difficult for children to engage in common activities like running, playing sports and writing.

Humira is the first biologic treatment for JIA to be approved since 1999, the company said in a statement. The drug is injected once every two weeks.

JIA is the most common chronic rheumatic disease in children, with symptoms including limping, joint swelling, and stiffness when waking. In clinical testing, 171 patients aged 4 to 17 had fewer "flares" than those who took a non-medicinal placebo, Abbott said. Common side effects included pain and/or reaction at the injection site.

Humira is already FDA-approved to treat adults with several conditions, including rheumatoid arthritis, the intestinal disorder Crohn's disease, and the skin disorder plaque psoriasis.

More information

The FDA has more information about this medication.