This release summarizes results from a group of three phase 3 studies that evaluated ixekizumab, a new drug treatment for psoriasis. The clinical trials enrolled nearly 4,000 patients from 21 countries. About 80 percent of the patient volunteers with moderate-to-severe psoriasis that received the drug saw improvement that lasted about a year, according to the release. The release avoided exaggeration of benefits, and carefully noted the side effects and that the drug manufacturer, Eli Lilly, funded the research and hired the first author as a paid consultant. A little more information about the drug itself — specifically that it is an injection — and a discussion of the cost would have made this an even more thorough elease.
An estimated 7.5 million people in the United States have psoriasis, an inflammatory auto-immune disorder of the skin and other tissues, according to the American Academy of Dermatology. The positive results being published in a high-level New England Journal of Medicine report (on which the release is based) will likely result in this treatment being used in clinical practice.
The release does not mention cost or whether it’s covered by private insurance or Medicare, and in this case, it’s a pretty big omission. This may be an enormously expensive treatment for patients — and it’s why we have a cost criterion in our reviews. The hopeful psoriasis patient who sees this release without a cost discussion might already have their hand on the phone to call their dermatologist. Here’s a very rough estimate of what that patient might face in terms of cost: Based on a conservative wholesale price of roughly $4,000 per 80 mg injection and following the recommendation (found on the package insert) of two injections every two weeks for 12 weeks, followed by monthly injections, we calculated $48,000 for the first 12 weeks plus $36,000 for the following 9 months or $84,000 total.
The release stated that by week 12, “76.4 to 81.8 percent of patients had their psoriasis classified as “clear” or “minimal” compared to 3.2% of patients on the placebo. By the 60th week, 68.7 to 78.3 percent of patients had maintained their improvement.”
We also wanted more detail on the measured strength of the response for each patient. For example, what constitutes “minimal”?
The release adequately addresses harms and notes that long-term side effects are unknown with this sentence:
“Adverse events associated with ixekizumab included slightly higher rates of neutropenia (low white blood cell count), yeast infection and inflammatory bowel disease compared to the placebo. The safety of therapy longer than 60 weeks will need to be monitored in the future.”
The release clearly and thoroughly describes the three phase 3 international trials at 21 sites, that they enrolled a large number of patients, and that they were randomized and controlled.
There was no disease mongering. The release describes what psoriasis is and its prevalence, and explains that these trials were for moderate to severe psoriasis which covers at least 10 percent of the body.
The release is very transparent in stating that the drug manufacturer paid for the research and that the lead researcher is a paid consultant to Eli Lilly.
The release did not compare the many different ways that patients treat psoriasis, some with topical agents and some with oral steroids or other medications.
The release states that the drug has been approved by the FDA following the completion of the trials. This is a strong indication that the drug is or soon will be available. The release should have noted that the drug is already being marketed under the brand name Taltz.
The release makes an understated claim to novelty with this quote from the lead researcher:
“Ten years ago, we thought complete clearance of this disease was impossible. It wasn’t something we would even try to do. Now with this drug, we’re obtaining response levels higher than ever seen before.”
There was no unjustifiable language in the release.