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U of Pittsburgh recap of COPD drug study touts ‘statistically significant’ results, but are they meaningful to patients?

Therapy proves effective in subgroup of COPD patients

Our Review Summary

harms of cancer screeningThis news release describes two studies published in the New England Journal of Medicine that looked at the benefit of using the drug mepolizumab to treat chronic obstructive pulmonary disease (COPD) patients who had an eosinophilic phenotype — an unusual proportion of eosinophils cells in the blood. Patients with a higher level of eosinophils face more frequent flare-ups that can send them to the hospital or emergency room. The release does a number of things well. It provides some numerical data to back up its claims of efficacy and does a good job of disclosing the commercial interests involved in funding the study. However, the release doesn’t mention the high cost of the drug or any possible side effects of its use. Moreover, the most useful information about the extent of the benefit provided is buried toward the bottom of the release. Although the release touts these benefits as “statistically significant,” it is unclear if the modest differences between groups would be meaningful to most patients.

 

Why This Matters

COPD is a chronic inflammation of the lungs that seriously compromises breathing in these patients. An estimated 40 percent of COPD patients have an eosinophilic phenotype that has limited their successful treatment in the past. Since there is no cure for COPD, improvements in its treatment can mean a substantive improvement in the quality of life for patients coping with the disease. If a new drug approach shows promise in treating the disease, then it could be a step forward for patients and a new tool for healthcare providers.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There is no mention of the costs of the drug mepolizumab in the news release. An online search reveals that the price for the drug can run from $2,800 to $4,200 per vial (a one month’s supply). Given that the drug appears effective only with some COPD patients, and its considerable price, readers would benefit from having this information, as well as perhaps the costs of standard therapies for COPD (triple inhalers and corticosteroids) which might still be needed by these patients.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The primary endpoint of the studies was to reduce the number of flare-ups that sent COPD patients either to the hospital or to the emergency room.

The release reports on the findings of two studies looking at the usefulness of the drug in a subset of COPD patients. For the METREX trial, which enrolled 837 volunteers for one year, it says, “The patients with high eosinophil counts who received mepolizumab had a statistically significant 18 percent lower rate of moderate/severe exacerbations (1.4 per year compared to 1.7 per year) than those in the placebo group.”

It’s not clear what a difference in exacerbation rate of 0.3 per year really means. Does this mean that each person will get one less exacerbation about every 3 years? That doesn’t sound like much of a difference.

For the METREO trial, the release said, “the exacerbation rate was reduced by 20 percent in the high eosinophil group after 100 milligrams of mepolizumab. The METREO results narrowly missed statistical significance.”

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release doesn’t describe any possible side effects from the use of mepolizumab, even though there are several. They include headaches, back pain, fatigue and flu symptoms, urinary tract infections, abdominal pain, itching, eczema, and muscle spasms.

To its credit the release does say that the side effects encountered from the drug and the placebo were similar. “The safety profile of mepolizumab did not differ from placebo in either trial,” it says.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

We’ll give the release a satisfactory in this category since it describes both studies as phase 3, randomized, placebo-controlled, double-blind, parallel group trials.

While it deals with a subgroup of COPD patients, the focus on subgroups here is appropriate since the researchers are pre-specifying that a subgroup will be studied, separate from simply looking for subgroups within a larger study.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering here.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The release identifies GlaxoSmithKline as the funder of both trials and names numerous GSK employees as authors of the study. The latter makes it possible that the biases could have been introduced in the writing process.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The news release notes the standard treatments for COPD are “triple inhaled therapy” including bronchodilators and glucocorticoids.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The release gets a satisfactory in this category since it mentions that the drug maker intends to seek FDA approval for its use in this type of patient, a fact that suggests to readers that it isn’t currently available to patients.

Does the news release establish the true novelty of the approach?

Satisfactory

The release claims that the study showed that eosinophilic inflammation plays a role in flare-ups in COPD, that mepolizumab provides “a new treatment option for patients with treatment-resistant, moderate to severe COPD,” and that the study identified a potential  biomarker for the disease.

If this research proves that the drug mepolizumab is effective in these patients, then surely it is novel enough for a news release, but the results would require a larger confirmatory study to assure that.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

No unjustifiable language is used in this news release.

Total Score: 8 of 10 Satisfactory

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