This story about the results of research for what would be the first biologic treatment of moderate-to-severe eczema (atopic dermatitis) in adults provides plenty of good news to patients.
However, while the story accurately summarizes some of the important study results, it fails to alert readers to vital details about the trial design and funding. Not only is there no mention that the makers of the drug paid for the trials and hired writers to produce the article that appeared in the New England Journal of Medicine, the lone independent expert quoted actually receives consulting and speaking fees from one of the drug makers.
Also, the story mentions three patients, but not one who had less than spectacular results. Including one of the many patients who did not see their eczema and itching completely disappear would have provided a more balanced view of the trial results.
When a drug study is paid for and written by companies that are seeking FDA approval for a treatment, stories should pay special attention to conflicts of interest, study design, and the way the results are presented, in order to help readers sort out hard facts from sponsor spin. This story highlighted all the positive news, while glossing over information that might raise questions, including the lack of independent interpretation of the trial results.
The story reports that the company says the price has not been set. It also notes that “It is a biologic, the most expensive type of drug, and is injected every two weeks.” The story could have offered readers a more detailed picture by noting that a widely prescribed (and heavily advertised) biologic treatment for Crohn’s Disease, Humira, costs about $2,000 per dose or about $50,000 per year. Of course, the amount paid by patients varies widely depending on insurance coverage.
The story reports that “most” patients said their itching disappeared within a few months and that nearly 40 percent saw “saw all or almost all of their rash disappear.” Readers need more specifics than that–is “most” 51% or 99% of patients, for example? And how did these results compare to the placebo group?
Another problem is that none of the three patients highlighted in the story had less-than-spectacular results. Their stories would have been more emblematic of the bigger picture if at least one of those three had represented the 60 percent of patients–the majority, that is–who did not see their rashes almost disappear and the one in 10 patients who did not report such dramatic reductions in itching. There is also no mention that about one in 5 patients on the experimental drug had to receive “rescue” treatment because symptoms became “unacceptable.”
The story does say that patients receiving dupilumab reported slightly more cases of conjunctivitis, and swelling around the injection site, than those receiving the placebo injections. The story would have been more complete if it had also noted that a few patients saw their eczema get worse and that many also reported upper respiratory infections, though the rates were similar to those receiving placebo injections.
The story reports some key facts about the study design (comparison to placebo injections), number of patients (nearly 1,400 in two trials) and duration (16 weeks), and that researchers would like to see longer-term data.
The story could have been clearer that this trial did not include children, even though children are far more likely than adults to suffer eczema. Also, it did not point out that some of the most dramatic statistics were from secondary endpoint results (including the improvement in itching), which should be viewed with more caution than the primary endpoint (a global assessment of the patient).
The story also does not address criticism of the type of primary endpoint used in the trials. As this systematic review revealed, “global assessments are used frequently in studies of AD, but their complete lack of standardized definitions and implementation preclude any meaningful comparisons between studies, which in turn impedes data synthesis to inform clinical decision-making. Standardization is urgently required.”
Close attention to study design is especially important when reporting on trials funded and managed by companies seeking approval of the products they are studying.
The estimate of the prevalence of “uncontrolled, moderate-to-severe” eczema used in the story seems to be in line with conservative estimates. As noted above, the story would have been better if it had told readers that eczema is far more common in children than adults, and that preliminary studies involving children are just getting underway.
This story fails to tell readers that every statistic and every expert quote is from sources funded by the companies, Sanofi and Regeneron, which are seeking approval to sell dupilumab. Not only were both trials funded by the companies, they largely controlled the writing of the New England Journal of Medicine article, to which the researchers “provided input” and “final approval” of material produced with support from “medical writers who were paid by the sponsors.”
In a startling omission, readers are not told that the lone “independent” expert receives consulting and speaker fees from Regeneron. The story describes Dr. Mark Boguniewicz as “an atopic dermatitis expert at National Jewish Health and the University of Colorado School of Medicine who was not involved with the study.” The story should have reported that Boguniewicz received more than $37,000 from Regeneron for consulting, speaking and travel reimbursements last year, according to Open Payments, a federal web site that collects reports of industry funding of physicians.
The story notes that many creams and lotions fail to provide relief to people with moderate to severe eczema. It also reports that many patients try off-label treatment with immunosuppressive drugs or steroids, which can have serious side effects.
The story would have been stronger is it had pointed out that any patient who went to any other course of therapy would be taken out of the study, discouraging any patient from using another therapy if they are still symptomatic.
The story reports that the companies are seeking FDA approval of dupilumab and that the agency has given the drug “breakthrough” status, which allows for expedited development and review. It would have been helpful if the story had acknowledged that this doesn’t necessarily mean “breakthrough” in the way many people understand the word.
It is clear that this drug would be the first biologic treatment for moderate to severe eczema.
It is clear that the story includes original reporting.