This is a brief news story about a drug company announcement of clinical trial results. Because patients as well as investors will read the story, it’s important that the story address details such as cost, side effects and limitations of the trial, even if only briefly. Instead, this story mostly just rehashes the company news release.
Not only is psoriasis common, but when it’s more advanced it’s difficult to treat. It also can be quite distressing for many patients because it can be quite noticeable in public, itchy, and painful.
The market forces involved are substantial. One source estimates the global psoriasis drug market will top $20 billion by 2022. The stakes are high–not only for the drug companies and investors, but also for patients who live with the disease. Journalists should do more than repeat what a drug company says about a trial–they should scrutinize the claims.
A cost comparison of the two drugs highlighted in the study — Johnson & Johnson’s Tremfya and Cosentyx from Novartis AG — wasn’t provided and would have been helpful.
The list price of a 100-mg dose of Tremfya (to be given once every two months) is about $10,000. For Cosentyx, around $4,700 (unclear if dosing is equivalent to Tremfya).
Regardless, drug costs for severe cases of psoriasis can quickly get into the tens of thousands of dollars for some patients.
From the story:
After 48 weeks of therapy, 84.5 percent of patients treated with Tremfya showed 90 percent improvement in disease symptoms [as measured by the Psoriasis Area Severity Index (PASI)], while only 70 percent of those treated with Cosentyx showed similar results.
It’s also noted that Cosentyx had a “slightly more rapid onset of response.” This is just enough to merit a satisfactory rating.
What’s not mentioned is that superiority of Tremfya was NOT demonstrated in five secondary endpoints. (As noted in this news release from Janssen Pharmaceutical Companies of Johnson & Johnson.) Also, we also think it would be valuable to tap an independent source to answer: How clinically significant is it that 14.5% of patients did better on Janssen’s Tremfya?
Since Tremfya is known to weaken the immune system, it places patients at an increased risk of bacterial, fungal, and viral infections.
People taking this drug, and other immunosuppressives like it, must be screened for tuberculosis, since it could dramatically accelerate the disease.
None of this was mentioned.
The results come from this Janssen-sponsored Eclipse trial — a phase 3, multi-center, randomized, double blind comparison of Tremfya, and the competing drug Cosentyx (from Novartis AG). However, the story provided scant details on the study, so readers would be unable to establish the quality of the evidence without going and looking up the study details. Was it randomized and blinded? What were the limitations? Has the trial been peer reviewed and published? Those are the details we’re looking for.
No disease mongering.
The story does well to inform readers that plaque psoriasis is fairly common, affecting about 7.5 million Americans.
Two glaring problems here.
First, the only quote used in this very short story is directly lifted (without attribution) from the news release. No independent sources are included.
Furthermore, it says it comes from the lead investigator of the study (true), but fails to mention he’s a paid consultant for Janssen.
Another weakness of this story is that alternatives are not mentioned. In addition to a multitude of other immunosuppressant drugs, there are a host of treatments available for adults with moderate to severe plaque psoriasis, including:
Light therapy, Vitamin A & D derivatives, as well as other medications that don’t work via immune system suppression.
Also, bear in mind, these are symptomatic treatments only, since there is no known cure for psoriasis.
Availability is implied but it should have been made more clear when these drugs received FDA approval, and what they’re approved for.
There are a number of other biologic drugs that treat psoriasis by altering the immune system (this makes sense, because psoriasis is an autoimmune condition), but Tremfya blocks a specific part of the immune system that has not been targeted before. In other words, it is “first in class.” The article does not touch on this.
The only quote used is drawn directly from the news release, without attribution.
Systematic, Criteria-Driven
In war, the first casualty is usually the truth.
@garyschwitzer https://twitter.com/garyschwitzer/status/1245315616866795521
Analysis of how unvetted rough-draft #COVID19 "studies" called preprints are credulously given the same weight in the media as peer-reviewed science published in established journals. Reminder why @garyschwitzer and his website are such important reads for journos and the public. https://twitter.com/garyschwitzer/status/1245315616866795521
Whether you’ve heard of preprints or not, this article explains current context. We see strong caveats lacking in news stories trumpeting preliminary #COVID19 research in preprints. https://www.healthnewsreview.org/2020/04/strong-caveats-are-lacking-as-news-stories-trumpet-preliminary-covid-19-research/
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