Our Review Summary
This news release asserts that a study found that combining two biologic drugs which contain extra-low doses of antibodies against tumor necrosis factor (TNFα) and interferon (IFN) can “improve the efficacy of standard rheumatoid arthritis therapy and decrease cardiovascular risk.” But the accuracy of that statement depends on what your definition of “cardiovascular risk” is. If your definition includes the risk of heart attacks and strokes (as it surely does for most people), then the statement is questionable at best. The release does not mention any of those outcomes and instead focuses on “unstable angina, severe hypertensive crisis, and deterioration of chronic heart failure.”
The news release is rich in mechanistic details, ie: how the treatments’ processes may help reduce markers of cardiovascular risk, but poor in important details of interest such as potential harms, costs and impacts on heart attacks or strokes.
Granted, it was a small study, but it would have benefited from appropriate caveats around the actual outcomes observed, the potential for harms, and an overall sense of context.
[Editor’s note: The European Society of Cardiology, which issued the release, has appeared on HealthNewsReview.org’s Wall of Shame twice before (see here and here) and this release comes close to meriting a repeat appearance.]
Why This Matters
In rheumatoid arthritis cytokines, a type of proteibn such as tumour necrosis factor (TNF) and interferon (IFN), start to attack healthy cells. If low-dose anti-TNF or anti-IFN drugs could reduce the symptoms of rheumatoid arthritis as well as decrease cardiovascular risk they may make a huge contribution to rheumatoid arthritis sufferers. If many people with rheumatoid arthritis also have a higher risk of cardiovascular disease it is useful to study if biologic drugs can reduce those risks by slowing down or halting the disease process.
Criteria
Not Satisfactory
No mention of costs, whatsoever. This may be a lost learning opportunity because these drugs are not only very expensive, but are also at the ends of their patent lives and hence generic companies are making cheaper biosimilars.
Not Satisfactory
The release offers some quantification of benefits when it describes the “incidence of cardiovascular events (unstable angina, severe hypertensive crisis, and deterioration of chronic heart failure)” as being 37% in conventional disease-modifying drugs group compared to those who also took anticytokines (at 13%).
Normally, that quantification would earn the release a satisfactory rating but the definition provided here for “cardiovascular risk” does not include heart attacks and strokes. It’s misleading to leave them out.
Not Satisfactory
No mention of harms, and there are known rare, but serious, adverse effects associated with all of the biologic drugs used to treat rheumatoid arthritis.
Not Satisfactory
What the study description needed was a caveat saying that a 68-person trial might be preliminary, or interesting, or even hopeful, but certainly not definitive. In addition, the release doesn’t mention how the outcomes were measured and if the study was blinded on the part of either the patient or the research observer.
Satisfactory
No obvious disease mongering here. We would caution that whenever a drug study encourages physicians to prescribe the drug more often, particularly in patients with mild disease, it could be construed by some observers as disease mongering.
Not Applicable
We learn that Professor Aida Babaeva, the lead investigator, is the head of the Department of Internal Medicine, Volgograd State Medical University, Volgograd, Russia, but not the degree to which she may have connections to companies making these drugs. Those kind of clarifications are important.
Not Satisfactory
There are a range of alternatives (statins, antihypertensives, anticoagulants) that can help reduce cardiovascular risk in patients but none of these alternatives are mentioned in the context of the study. Even one line acknowledging the existence of these alternatives would have rendered this a much more satisfactory release.
Not Satisfactory
It can be safely assumed that the biologics mentioned in the study are on the market, but are the “extra-low dose combination of two anticytokines” readily available? We’re not sure.
Satisfactory
This might be worth the benefit of the doubt. The news release does not misrepresent the novelty of the approach and the lead investigator asserts that not all rheumatoid arthritis patients should be using this combination, saying “In patients with highly active disease, the standard biologics are better at preventing severe complications such as progressive joint destruction and/or systemic manifestations (vasculitis, uveitis, involvement of internal organs).” It appears that the use of the “extra low” doses are simply a novel use of standard drugs, possibly in patients who would never have used the drugs in the past.
Satisfactory
There are no obvious examples of the use of unjustifiable descriptors. However, the first paragraph seems to suggest that it is well-known that these drugs will reduce rheumatoid and cardiovascular disease. The implication is that these have been well-proven, but we think that’s still an open question.
Total Score: 3 of 9 Satisfactory
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