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A new study looking at the side effects of Actemra and other rheumatoid arthritis drugs challenges conventional wisdom that randomized clinical trials, considered the gold standard of drug and medical device studies, are more revealing than observational studies.
Researchers at the Institute of Social and Preventative Medicine (ISPM) at the University of Bern in Switzerland published a study last month in the medical journal Rheumatology, comparing the two techniques as they have been applied to Actemra, Enbrel and Rituxan; all drugs used to treat rheumatoid arthritis (RA), and found observational studies may better reflect the real-world effectiveness of such drugs.
Randomized clinical trials (RCTs) involve taking groups of test subjects and giving some the active ingredient and others a placebo which has no actual active ingredient and looking at the differences in efficacy and safety. They are usually “blind” meaning that even the doctors administering the drugs are unaware of whether they are giving patients the actual drug or the placebo. Observational studies collect data on the drugs’ use in real world settings.
Researchers conducted systematic literature reviews of randomized clinical trials and observational studies, comparing the data and whether baseline characteristics changed over time. They found a number of differences in the observational studies once the drugs were in use when compared to the randomized clinical trials that preceded their release to the market.
According to the findings, when looking at Actemra and similar drugs, observational studies revealed that the typical patient was three years older than assumed in the clinical trials, had taken 1.6 more drugs previously to treat their condition than the clinical trials predicted, and other differences which could result in safety and effectiveness differences than those found during the clinical trials.
“There are substantial systematic differences in patient characteristics between RCTs and registries in RA,” the researchers concluded. “The efficacy seen in RCTs may not reflect real-world effectiveness.”
Actemra Health Concerns
The findings come as a growing number of individuals nationwide are reviewing potential Actemra lawsuits, as questions have emerged about serious risks associated with the medication that are not adequately disclosed on the label warnings.
Actemra (tocilizumab) was introduced in 2010, as a second-line treatment for rheumatoid arthritis, in severe cases where individuals have not responded to other drugs. In May 2017, the FDA approved expanded use to treat giant cell arteritis, and the medication has grown to generate over $1.6 billion in annual sales.
Unlike other competing rheumatoid arthritis drugs, Actemra warnings do not include information about certain health risks linked to competing treatments, such as Humira, Remicade and Enbrel. Therefore, many doctors and consumers are under the impression that Actemra is safer. However, recent reports suggest that users may face the same, or higher risks.
A recent independent review of adverse event reports submitted to the FDA identified a higher-than-expected number of severe injuries, including heart attacks, strokes, heart failure, interstitial lung disease and pancreatitis. In addition, the drug has been linked to at least 1,128 deaths since 2010. As a result, some are calling for Actemra warnings to be added, which may cut into sales.
According to allegations being investigated against the drug maker, evidence suggests that Roche knew or should have known that the drug carried similar risks to other rheumatoid arthritis drugs, but withheld information from the label to create a false impression that their drug was safer.