Rheumatoid arthritis drug clears hurdle

A new drug knocks down rheumatoid arthritis symptoms in patients who have failed to benefit from other medications, according to a study released online June 29 in The Lancet.

The new findings may clear the way for approval in Europe for the anti-inflammatory drug, called golimumab. The drug was approved for use in the United States in April.

Rheumatoid arthritis results from inflammation of the joints, causing swelling and tenderness. Golimumab, marketed under the brand name Simponi, inhibits an immune protein called TNF-alpha that contributes to this runaway inflammation. While three other TNF-alpha inhibitors are already in use for rheumatoid arthritis, many people stop taking these drugs because of side effects or a lack of effectiveness.

No previous trial had tested golimumab against a placebo in a randomized fashion in patients who had already failed to improve while taking one or more of the other TNF-alpha inhibitors. In the new study, physician Josef Smolen of the University of Vienna and an international team of researchers identified 461 such patients, average age 55, in 10 countries. Patients had a median number of 26 tender joints and 14 swollen joints when they started the trial—despite having taken other TNF-alpha inhibitors.

The patients received an injection every four weeks. Two-thirds received golimumab, and one-third got a placebo. Most patients also continued to take other anti-inflammatory drugs, but not other TNF-alpha inhibitors.

After 14 weeks, researchers determined how many patients had improved by at least 20 percent since the start of the study, using standard scoring of symptoms. The team found that 37 percent of the patients getting golimumab but only 18 percent of those receiving the placebo had improved that much.

When researchers looked only at patients who stopped taking other TNF-alpha inhibitors because they weren’t working, the new drug provided similar benefits.

The scientists also found that on average, those receiving golimumab had 14 tender joints after 14 weeks, compared with 20 in those getting the placebo injections.

“Switching patients from one TNF-alpha inhibitor to golimumab is effective and generally well tolerated,” the authors conclude.

People diagnosed with severe rheumatoid arthritis often get methotrexate, sold as Trexall or Rheumatrex, a multipurpose drug that helps most patients. But as many as 40 percent of people fail to benefit from it, says Yusuf Yazici, a rheumatologist at the New York University Hospital for Joint Diseases. Doctors often turn to one of the three existing TNF-alpha inhibitors — etanercept (Enbrel), infliximab (Remicade) or adalimumab (Humira) — or a combination of them. Many patients continue to take other anti-inflammatory drugs.

The availability of these three TNF-alpha inhibitors has added an extra layer of protection for many patients, Yazici says, but still leaves 20 to 30 percent of patients without control over their disease, which can be debilitating, he says.

The new trial shows that these patients now have an additional option in golimumab, Yazici says, although it probably won’t be a first option for rheumatoid arthritis until its effects have been monitored over time. “We now have four valid anti-TNF-alpha drugs,” Yazici concludes.