New Rheumatoid Arthritis Drug Shows Promising Results

Treatments for conditions and diseases are as unique as the patients themselves, which means that what works for one person may not work for another. This often poses a challenge in finding an effective and tolerable medication. For instance, severe rheumatoid arthritis (RA), a chronic disease mainly characterized by inflammation of the lining of the joints, is often treated with one of three, or a combination of tumor necrosis factor inhibitors (TNF-a); etanercept, adalimumab or infliximab. Unfortunately, 30 to 50 percent of patients either fail to benefit from these drugs or are forced to stop taking them because of side effects. But, as the old adage goes—“If at first you don’t succeed, try, try again,” and researchers say switching to a new TNF-a inhibitor may just do the trick.

In a recent trial, golimumab, approved for use in the U.S. in April and marketed under the brand name Simponi, was shown to reduce the signs and symptoms of RA in a significant number of patients who had failed to benefit from other TNF-a inhibitors. No controlled trials prior to this study had evaluated whether patients who didn’t respond to one TNF-a inhibitor might respond to another.

The Go-After trial, led by Professor Josef Smolen of the University of Vienna, involved 461 patients from 82 sites in 10 countries. At the beginning of the trial, patients had an average of 26 tender joints and 14 swollen joints, despite having taken other TNF-a inhibitors. The patients randomly received an injection every four weeks for 24 weeks; two-third got golimumab and one-third a placebo. Most patients also continued to take other anti-inflammatory drugs, but not other TNF-a inhibitors.

When the researchers assessed the patient’s progress at week 14, they found that 35 percent of patients receiving 50 mg doses of golimumab and 38 percent of patients receiving 100 mg showed at least a 20 percent improvement in arthritis symptoms, compared with 18 percent of patients receiving placebo injections. The 58 percent of patients who had discontinued previous TNF-a inhibitor treatment due to lack of effectiveness showed even higher rates of improvement; 36 percent on 50 mg and 43 percent on 100 mg golimumab.

The safety profile of golimumab was consistent with that of other TNF-a inhibitors. After twenty-four weeks, 5 percent of patients on 50mg golimumab, 4 percent on 100mg golimumab, and 10 percent of patients on placebo experienced serious adverse events. “Golimumab reduces the signs and symptoms of active rheumatoid arthritis and improves physical function in patients who had previously received TNF-a inhibitors, which suggests that switching patients from one TNF-a inhibitor to golimumab is effective and generally well tolerated,” the authors concluded.

“Do we really need another TNF-alpha inhibitor? As long as no available drug is effective in all patients, the answer would seem to be ‘yes.’” said Yusuf Yazici from NYU Hospital for Joint Diseases in New York in an editorial accompanying the study findings. “For those patients who have failed or had an inadequate response to etanercept, infliximab, adalimumab, or abatacept, golimumab might be a good option,” he said, venturing that the drug probably won’t be used as a first-line option for RA until its effects have been monitored over time. “We now have four valid anti-TNF-alpha drugs,” he concludes.

About 1 percent of the world’s population is afflicted with RA, women three times more often than men. This autoimmune disease can exact a heavy toll on the lives it touches, making even the simplest daily activities difficult to accomplish. There is no known cure for RA, and doctors don’t know what causes it, although infectious agents such as viruses, bacteria and fungi have long been suspected.

The study was funded by Centocor Research and Development and the Schering-Plough Research Institute and published online in The Lancet.