Few rheumatoid arthritis clinical trials compare drugs: study

To test whether a new drug is an improvement over existing treatments, the ideal clinical trial would compare the medications head to head, but few trials of rheumatoid arthritis treatments happen that way, according to a new study.

Instead, researchers found that for certain new rheumatoid arthritis medications, subjects in the comparison groups were often assigned to continue taking a drug that didn't help them or to take a fake drug called a placebo - in both cases effectively depriving those patients of treatment for their disease.

"Of course it's easier to compare to a placebo than an active treatment but in no way can it justify exposing patients to irreversible morbidity," said Dr. Candice Estellat at the French national medical research institute, INSERM, who led the study.

Her concern is that if studies don't compare a new drug to other effective ones, people's conditions will persist or even worsen throughout the study.

Additionally, without so-called head-to-head trials, doctors will have little evidence to go on to determine whether one treatment is better than another, Estellat said.

Rheumatoid arthritis is an autoimmune disease that causes inflammation and damage to joints.

About 1.5 million adults have the painful disorder, and they typically require lifelong treatment with physical therapy or medications, such as methotrexate.

The newest forms of rheumatoid arthritis medications to become available are called biologic disease-modifying antirheumatic drugs (DMARDs).

These include the brand-name medications Enbrel and Humira. They come in the form of an injection, and cost around $15,000 per year.

Estellat and a colleague gathered information on all clinical trials of biologic DMARDs registered with the U.S. government's clinicaltrials.gov website and that were ongoing between 2002 and 2009.

She said they decided to do the study after hearing from specialists about the lack studies comparing these new drugs against other biologic DMARDs.

Of the 91 trials they identified, just five studies compared one biologic medication to another.

"Unfortunately we were not surprised as it confirms rheumatologists' feeling(s)," Estellat said.

The remaining trials will not provide doctors and patients with information for making evidence-based decisions, she and her coauthor write in the Archives of Internal Medicine.

"There (are) plenty of studies to show that A is better than placebo, B is better than placebo, C is better than placebo but so few to know which one is the best between A, B or C," Estellat told Reuters Health by email.

Not only are placebo-compared experiments less useful in understanding how well a drug works compared to others, but, the report points out, they may violate international ethical research standards and specific guidelines from the American College of Rheumatology if people are not given treatment for a serious condition like rheumatoid arthritis.