The story reports on a journal article published in the New England Journal of Medicine (NEJM), regarding several clinical trials that found the arthritis drug tofacitinib (marketed under the name Xeljanz) was an effective treatment for ulcerative colitis in some patients.
The story does a good job of describing the trials, the potential benefits, and the potential side effects associated with Xeljanz use for ulcerative colitis — and makes clear that it is likely too soon to tell whether Xeljanz will be used as a first treatment for the disease. However, the story does not address the cost of the drug, which is considerable.
One thing that weakened the story: It speculates too much on the implications of the study before describing any aspect of the study itself.
Those with ulcerative colitis, and their loved ones, are likely eager for news of new treatment options, particularly if they have exhausted other drug treatment options. That makes it particularly important to present related research findings in context, clearly articulating the limits of the new research and what it can tell us about benefits, risks, and costs. For the most part, this story does a good job here — though some discussion of cost would have made it stronger.
The story doesn’t mention cost. This is a significant oversight, given that a glance at online pricing guides indicate the drug costs around $4,000 per month (treatment for the bulk of the clinical trial patients was for two months, though some patients took lower “maintenance” doses for a year).
The story does a nice job here. The NEJM article reported on three trials. Two of the trials involved treating patients for whom conventional drug therapy didn’t work. The story not only tells us how many patients went into remission for each trial (19 percent and 17 percent), but how that compared to people in the trials who went into remission and were taking placebo (8 percent and 4 percent, respectively). The third trial was of people who had gone into remission using Xeljanz. In this trial, patients were given lower, “maintenance” doses of the drug — either 5 or 10 milligrams. In this trial, 11 percent of patients on placebo were in remission after a year, compared to 35 percent for those on the 5 mg dose, and 40 percent for those on the 10 mg dose. Overall, the story provided detail and context in reporting benefits, which is good to see.
We did wish these benefits were included higher up in the article, which instead initially focused mostly on the implications and promise of the drug before delving into the findings.
Over the course of three paragraphs, the story discusses a variety of adverse health effects experienced by patients participating in the clinical trials, including infections, nonmelanoma skin cancer, “heart problems,” and an increase in cholesterol levels.
As with benefits, the story compares the number of adverse health events in those taking Xeljanz with the number of adverse events in those taking placebo — which is useful for helping readers place the risk in context.
The story does a good job of clearly, but concisely, summarizing the design of the three clinical trials, letting us know the groups were randomized to receive either treatment or a placebo. More information on the number of patients in each cohort would have been nice, but the story is solid here.
No disease mongering here. The story accurately describes the prevalence and symptoms of ulcerative colitis.
The story handles this very well. The study’s lead author is clearly identified, the story clearly states that Pfizer (which makes Xeljanz) funded the study, and that the lead author has consulted for Pfizer. In addition, two independent sources are included in the article. One of those sources was also the author of an editorial on the NEJM paper, which the story notes.
This one is a close call. The story makes clear that Xeljanz is given in pill form, as opposed to infusion or injection, which is a point worth making. It also notes that the trials only involved patients for whom existing pharmaceutical treatments had failed. In addition, the story tells readers that patients don’t develop antibodies to Xeljanz, as they do with other pharmaceuticals in the same class of so-called “biologic” drugs.
The story does not, however, explain to readers why antibodies are important or relevant to the treatment process. The story also doesn’t mention surgical treatment options, which involve removing the colon and rectum. Ultimately, however, the story does a very good job of placing the drug’s potential use in context. One source, for example, notes that there is still far too much uncertainty to recommend making Xeljanz the first line of treatment, while another describes it as a potential “rescue therapy” when other options fail. Altogether, the story is more good than bad on addressing alternatives.
The story makes clear both that Xeljanz is already on the market for treating arthritis and that it has not yet been approved by the FDA for use in treating ulcerative colitis. It would have been helpful to note if some doctors currently prescribe Xeljanz as an off-label treatment for ulcerative colitis.
The story makes it clear that this would be one of the few “pill-based” biologic treatments for ulcerative colitis, and also that these results indicate a possible new option for people who haven’t seen symptom improvement with other medications.
The story clearly goes well beyond a news release.
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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