This news release describes the results of a somewhat small (121 patients) phase 2 safety and efficacy trial of a topical non-steroidal treatment for mild-to-moderate symptoms of eczema (atopic dermatitis). The release is based on a study published in the Journal of the American Academy of Dermatology, and offers substantial detail about the company (Medimetriks) which owns the U.S. rights to the experimental treatment, dubbed MM36. The MM36 compound is a non-steroidal anti-inflammatory ointment believed to stop itching and redness by blocking chemicals released by an enzyme known as PDE4 subtype B and active in causing inflammation. The release describes the percentage of improvement in symptoms over a period of eight weeks, but doesn’t describe or quantify what improvement means. And it highlights several alternative treatments, but offers no data on how MM36 compares with these existing therapies. Readers will learn little to nothing about the makeup of the test group, side effects, or costs.
A WSJ story on this eczema study, which was also reviewed by HealthNewsReview.org, shared an excessive optimism with respect to approval and availability of this treatment still in development.
As the release notes with admirable detail, atopic dermatitis — and the “red, swollen and cracked skin” that accompanies the “intense” itching associated with it — is estimated to strike 18 million people in the U.S. alone. Moreover, current therapies, such as corticosteroids, cause unwanted side effects when used over long periods of time, and some burning and stinging. Most people who have experienced eczema would agree that while not life-threatening, the symptoms are sometimes disfiguring and can be extremely unpleasant. A treatment that targets a particular enzymatic pathway without the potential downsides of current therapies would thus be welcome. And because these conditions are often chronic, the markets for such products can be highly profitable.
The release discloses the total 2015 sales of Otsuka, the drug maker, but offers not a penny’s worth of information about the costs of current therapies or whether the new product would be more or less expensive. Although there is no pricing for an investigational new drug still in clinical trials and not yet FDA-approved for sale, it would be helpful to consumers to know if part of the novelty of the product will be its availability and cost.
Although the release does give the mean percentage improvement scores compared to baseline measures and patient-reported outcomes (39% improvement for those volunteers assigned the MM36 compound compared to 3% on the placebo at week 2 and throughout the remainder of the 8-week study), it could have been greatly improved by saying specifically how many of the 121 experienced what percentage of improvement. There also is no information on what it actually means to say a condition has improved from “moderate” to “mild,” especially given that the treatment is being tested only for those with “moderate to mild” eczema. According to the published study, the number needed to treat (NNT, or the number of patients that need to be treated for one to benefit compared with a control in a clinical trial) was about 6 for an improvement of at least 2 levels on a 0 – 5 scoring system. According to that measure, the difference in improvement between the high dose cream and the placebo was about 18%.
The published research report clearly reports that some subjects experienced a worsening of symptoms, or no real change, but the release fails to mention any data on side effects. According to the study, the harms were about the same in the high dose group and the placebo, but were greater in the low dose group (and that difference was statistically significant).
The release doesn’t give the study methods in strong detail, but it does describe it as a double blind, randomized clinical and placebo control trial, which suggests a high level of evidence. The published study appears to show a low risk of bias. The study also showed there was a dose response between the high, low and control doses for the primary outcome event (degree of improvement) and except for some discrepancies in the adverse events rates (higher in the low dose group than in the high dose or placebo groups) there was fairly good precision and the NNT of 6 is not unreasonable. It would have been beneficial to readers if the release had included some information about the age, gender and race of those being treated, as well as more details about the patient-reported improvements.
The release doesn’t engage in disease-mongering. The release mentions a possible link to skin or blood cancer with the use of topical steroids which are in wide use today, but then notes that the studies suggesting the link have not proven the case.
The release doesn’t include any information about how the study was funded. The study itself discloses that several authors are paid consultants for the companies making the drug.
The release does give ample information about alternative treatments, including the standard treatments. We’d still like to know how the drug under development would be an improvement over alternative treatments, including some of the over-the-counter treatments available for patients with mild eczema. How much better would the new treatment be in terms of symptomatic relief? Also, there is no mention of the fact that there are other PDE4 inhibitors already under development and on the market for other inflammatory conditions.
Although industry-sponsored releases must avoid “forward looking” predictions about future drug approval, the release would have added useful information if it had noted whether this phase 2 trial would be followed by phase 3 trials. As it stands there is no way to gauge if or when this product will be available.
It seems overly optimistic to make this statement based on a phase 2 study: “MM36 is expected to be the 2nd topical PDE4 inhibitor available in the US and may offer unique benefits for patients suffering from AD.”
The release notes in two places that MM36 would be the second topical PDE4 inhibitor after a competing product (cisaborole, manufactured by Anacor Phamaceuticals). Cisaborole is further along in the approval-seeking process than MM36.
The news release does not employ unjustifiable language.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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