The news release announces the results of a phase II clinical trial published in the New England Journal of Medicine, which found that an experimental drug called guselkumab was more effective than a drug already on the market (called adalimumab) at controlling the symptoms of psoriasis. However, the release leaves some significant gaps, not giving readers any information about potential harms or costs associated with guselkumab. The release falls victim to the common practice of hyperbole in its headline. This was a phase II trial in a relatively small number of subjects. Suggesting that guselkumab is both more effective and less toxic than adalimumab is nothing more than speculation at this juncture. A more appropriate title would have been, “Early phase II trial suggests that new psoriasis drug may be more effective and has the potential to leave more of normal immune system intact.”
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, more than 5 million people in the U.S. have psoriasis. The disease can have a significant impact on quality of life, and treatment can be extraordinarily expensive, so information about new, effective treatment options is certainly worth noting. Psoriasis is an autoimmune disease that affects the skin. While psoriasis itself is not life-threatening, because it is an autoimmune disease, some pharmaceutical treatment options affect the immune system and can increase a patient’s risk of infections — and those infections may pose a significant health risk of their own. This makes it particularly important for readers to be aware of potential health risks associated with new treatment options.
The release does not address cost at all. While guselkumab is not yet on the market, HealthNewsReview.org has long argued that if it is worth discussing a drug’s treatment potential, it’s worth discussing what that treatment might cost — even if it is only in general terms. Certainly, readers of this release would be interested to know that the comparison drug, adalimumab (brand name Humira), costs almost $50,000/year. Considering the similarities between adalimumab and guselkumab, the release should have warned that if this experimental drug is approved, it might well also command a hefty price.
The release is fairly clear in this regard, reporting that 81 percent of patients taking a 200-milligram dose of guselkumab reported “minimal” or no psoriasis symptoms after 40 weeks of treatment, compared to 49 percent of patients taking adalimumab. The release doesn’t note that patients taking 200-mg doses of guselkumab did only slightly better than patients taking a 100-mg dose, and that the 100-mg dose fared slightly better at various points during the first 40 weeks of treatment. But that’s a level of detail that perhaps we can’t expect.
The release would have been better if it specifically noted that further study will be needed in order to find out if the observed benefits last longer than a year. The release also could have noted that the patients in this study were overwhelmingly white (91%) and male (71%), so it remains to be seen if a more diverse patient population would get similar benefits.
The release does not discuss harms at all, which is problematic. The authors of the paper noted the difficulty in identifying true rates of adverse events in the study given the discrepancy in the number of subjects in each treatment group. There was a 6:1 ratio of guselkumab subjects compared to adalimumab in the post placebo phase of the trial. While the true incidence of harm is unclear at the moment, some comment is necessary even in a press release. For example, according to the paper, 20 percent of patients who received guselkumab experienced “adverse events of infection” during the first 16 weeks of the trial, as compared to 14 percent among patients receiving a placebo and 12 percent of patients who received adalimumab. A higher rate of infection is certainly worth mentioning. Heck, even a comparable rate of infection is worth mentioning. Overall, patients who received guselkumab had lower rates of all “adverse events” compared to adalimumab over the first 16 weeks of treatment (50 percent versus 56 percent), and over weeks 16 through 52 of the study (49 percent versus 61 percent). But the rates of adverse events were still noteworthy, and the release should have addressed them.
This was a close one. The release does do a fairly good job of describing the overall study, but it fails to mention some important limitations.
It explains that it was a multi-center study of 293 adults, it describes the symptoms of the adults, and it describes the study design: some study participants got guselkumab, some got adalimumab, and some got a placebo. It also explains how the study evaluated the effectiveness of the drugs. However, the release does not mention that the number of participants who received guselkumab was relatively small at each dosage level. The press release notes, “…293 adult patients with moderate-to-severe psoriasis (defined as covering 10 percent or more of the body) were randomly assigned to receive varying doses of one of the two drugs or a placebo over 52 weeks.” This suggests that the three cohorts (placebo, guselkumab and adulimumab) were equal in size. Clearly this is not the case. So, when the story notes, “At week 40, for example, 81 percent of patients taking a 200-mg dose of guselkumab had a score of 0 or 1, compared to 49 percent of patients taking adalimumab,” it should have noted that this is in a sample of 42 and 43 subjects respectively. The release should have noted that the results for specific doses of drugs are based on just a few dozen patients.
The release should have highlighted a limitation that is noted in the journal article: “Furthermore, some elements of the study design limited the ability to assess uncommon adverse events or adverse events that might have developed during long-term treatment.”
And as we already noted, the study is based on a skewed patient population (91% white, 71% male), so it can’t be said that all sorts of psoriasis patients could expect similar results.
Psoriasis is a serious health condition, but this release takes it a bit too far. For example, in the fourth paragraph, the release states that psoriasis “also increases a patient’s risk for depression, heart disease and diabetes, among other conditions.” It would have been more accurate to say that it has been associated with, or is linked to, these other conditions. While psoriasis is correlated with an increased risk of multiple adverse health outcomes, it is not known to be the cause of any of them. In most, if not all, cases we know very little about the relationship between psoriasis and those health outcomes. The release also quotes the study’s lead author as saying that “the concept that psoriasis is ‘just something you live with’ is no longer appropriate.” But that source is also cited as saying that about half of all patients with psoriasis do not get any treatment. Whether that is by choice, or because the patients don’t have access to treatments or can’t afford the newer, very expensive drugs, it’s clear that many patients with psoriasis do live with the condition. Those dealing with psoriasis already know the value of treatment, they don’t need their condition written about in a way that may stir additional concern.
Although the release clearly notes that the study was funded by the company that manufactures guselkumab, and that the study’s lead author is a former paid consultant for the company, it fails to tell readers that the company was actively involved in the study. The journal article points out that Janssen Research and Development collected and analyzed the data. What’s more, “All the authors collaborated on writing the manuscript, with the assistance of professional medical writers employed by Janssen, and made the decision to submit the manuscript for publication.” That intimate level of involvement should have been made clear in the release.
The release discusses only two potential treatments: the drugs guselkumab and adalimumab. There are many additional options. Other medications include methotrexate, cyclosporine, and retinoids, among others. There are also a number of topical treatments and several forms of light therapy. The release would have been stronger if it had explained why guselkumab (or adalimumab, for that matter) are important treatment options or when physicians may incorporate medications like these into their treatment plans.
The release makes clear that the study was a phase II clinical trial, and that a phase III trial is ongoing. In other words, the drug will not be available in the very near future. Ideally, the release would remind journalists – and the public – what a Phase II trial means and what it doesn’t mean.
The release explains that guselkumab is novel because of its mode of action (i.e., how it works), compared to other, similar drugs. Specifically, the drug blocks a protein that’s implicated in psoriasis. It would have been nice if the release had included another sentence or two on how blocking that protein disrupts psoriasis (or its symptoms).
The release uses fairly cautious language throughout, as exemplified in the headline, which says only that guselkumab is “more effective” than adalimumab. However, readers have to be sophisticated enough to know that a phase II trial is merely an intermediate step in the clinical trial process. The release should have noted in the headline and lead paragraphs that further work is needed in order to reach firm conclusions about the effectiveness and potential side effects of this experimental treatment.