Our Review Summary
Without evaluating the evidence, it becomes one of those classic stories of a new therapy spun in the most favorable light possible based on a limited presentation at a medical meeting.
Why This Matters
Crohn’s disease is a terrible condition and more treatment options are needed. Thus this new research is welcome and we hope ustekinumab proves successful in phase 3 research. But in order to understand what the current study means, readers must know that data presented at conferences are preliminary and how independent experts assess it.
This story gives hope to those with a disease that can be devastating despite available treatments, but it doesn’t give the critical piece one expects from this type of article – reflection. Phase 2 studies are probably 2-4 years from FDA approval. One wants to know what the risks are. Did patients really fail all available treatments? What’s the assessment of experts unaffiliated with the research and product? Simply put, despite the hope of new medicine that could relieve suffering, which all of us want badly, this is the common hype that may or may not stand the scrutiny of time and full publication of the trial results.
Criteria
Not Satisfactory
While we’re given the size of the market, we don’t get the costs of the drug itself. It’s a biologic treatment and it ain’t cheap. Even if this story is targeted at a business audience, patient costs are extremely relevant.
Satisfactory
The study presented lots of numbers and defined the scales. We appreciated the Crohn’s Disease Activity Index (CDAI) thresholds for clinical response and remission, the subjects’ baseline CDAI scores, and the explanation of what a 100-point drop feels like to patients. Bravo for including these points and for mentioning that the study met its ‘primary goal.’ Great facts for readers to consider that are often left out of news coverage.
Not Satisfactory
There’s a mere sentence on serious side effects with no quantities. The note about the need for more studies on safety is important, but that’s not enough to satisfy this criterion. Perhaps more safety information wasn’t available at this time, but that’s the risk you run with conference data.
Not Satisfactory
We saw many important points about the study, including the number of subjects, their treatment history, the two-stage study design, doses, placebo comparator, treatment period, follow-up period, primary outcome [endpoint], and the need for longer-term and larger studies to better establish ustekinumab’s safety in Crohn’s disease. Unfortunately it missed a big point. While the article is up front that these data were presented at a conference, it failed to evaluate the meaning of that for lay readers. Conference abstracts have not undergone the same peer review as journal publications and are considered preliminary. In that sense, the article did not evaluate the quality of this evidence. Please see also our comment under Availability about the stage/phase of research.
Satisfactory
There’s no disease mongering about the prevalence of Crohn’s disease and the discussion of the specific subgroup of patients who were enrolled in this study.
Not Satisfactory
The only source is the primary investigator. And who funded the study? Presumably it was Johnson and Johnson.
Satisfactory
The story gets a check here for telling us that subjects in this study had tried TNF antagonists but didn’t benefit or couldn’t tolerate them. It gets another check when it mentions that when medicines for Crohn’s disease stop working, many patients require surgery.
There was room for more details here, too, or an outline of what’s unknown. The article states the trial was placebo-controlled in individuals who “failed” other approved meds, but that doesn’t mean we know how it compares to other meds commonly used, like prednisone.
Not Satisfactory
It was borderline on this criterion. On the plus, the current indication is mentioned, as well as trials into other conditions. But on the minus, our standard requires that articles provide readers with information about what phase of research the drug is in. It’s not clear what phase the study is at and how close the drug is to the market in even the best-case scenario.
The article calls the trial “mid-stage.” According to the press release, that means phase 2b. Many readers won’t know the significance of mid-stage, or that it’s only at the “late-stage” (phase 3) that trials are designed to meet FDA requirements. If it’s phase 2b, mid-stage, generally we’d expect another 2-4 years before piggy gets to market. That’s why we like to see a statement about exactly when patients could expect to see this medicine available to them. (Off-label use could occur before FDA approval, but given the expected price, it’s unlikely to be covered off-label.) It tempers the hope of a breakthrough with the reality that, even if it aces its upcoming exams, the drug probably won’t be readily available to patients until 2013-2015.
Satisfactory
Satisfactory, but with room for improvement. It’s clear that Stelara isn’t indicated by the FDA for treating Crohn’s and that sometimes current medicines aren’t enough. A few more details about what type of agent Stelara is, e.g., what it means to be a biotech drug or how it works, would have helped. It isn’t clear whether the compound itself is novel or even a “me too” drug for another already used for Crohn’s.
Satisfactory
The story doesn’t seem to have relied solely on the press release.
Total Score: 5 of 10 Satisfactory
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