This news release lays out in clear, lay language the findings of a study looking into whether reducing the amount of tumor necrosis factor inhibitor (TNFi) administered to patients with rheumatoid arthritis (RA) diminishes its effectiveness. It goes beyond the study to include quotes from the lead author that do a good job summarizing the work. But while the release touts the possible cost-effectiveness of the reduced-dose strategy, it does not say how much money might be saved if clinicians adopt it, or even provide a ballpark figure for what the drug costs. Perhaps direct costs aren’t as important for patients in Europe, where this release originated, but surely any journalist reporting on the story would want to put a figure on the potential savings — so why not put those numbers in the news release?
Cutting the amount of drug used would save money and might reduce the incidence or severity of side effects — both of which would increase value to patients and the health care system.
The news release includes a quote from the lead author, Dr. James Galloway, saying that his study findings offer “a more cost-effective option by substantially reducing the high drug costs associated with TNFi maintenance therapy.” But it does not specify how much the drug costs or how much might be saved with the new strategy.
The news release notes that there was no significant difference in outcome between those who got the standard dose and those who got the dose that was reduced by a third. It gives the absolute percentage of patients experiencing flares in both groups.
The news release says: “There were no significant differences in self-reported measures of disability (Health Assessment Questionnaire score) with either dose reduction strategy at six months.” But it is not clear whether self-reported measures of disability are limited to the effects of rheumatoid arthritis, or whether they also include side effects that may have been caused by the drug. According to the American College of Rheumatology, those side effects can include “an increased risk for all types of infections, including tuberculosis (TB) and fungal infections. Some of these infections may be severe.”
While the potential for side effects should have been mentioned, we’d note that reducing the TNFi dose should theoretically reduce harms. But that is an assumption that needs to be studied. This study is too small to do that.
The news release appears to lay out faithfully the data reported in the study. But it lacks information on the study’s limitations, particularly the fact that this was a very small study and that patients were followed only for 12 months. Because it’s so small, it might not pick up adverse effects or benefits from this regimen that would be evident in a larger study. The release should have included some cautionary statements.
The release mentions the potentially debilitating effects of RA, but does not exaggerate them. It would have been stronger if it had mentioned the prevalence of the disease and well as the prevalence of disability is in those with the disease.
No mention is made in the news release of who funded the study or whether there were any conflicts of interest. The study’s lead author, Dr. James Galloway, said in an email to HealthNewsReview.org that the work was funded by Arthritis Research UK, a charity. The study itself says the authors declared no conflicts of interest.
The release notes that conventional synthetic disease-modifying anti-rheumatic drugs such as methotrexate can prevent joint damage and loss of function. It adds that biologic therapy — usually a tissue necrosis factor inhibitor — is reserved for those who either don’t respond, or respond inadequately.
Although availability is not explicitly addressed, the release does note that biologic drugs are used as an add-on treatment option to methotrexate, which suggests that they are approved and available. This is true in the U.S., and also seems to be true in the UK, where the study originated.
The release doesn’t establish novelty. The implication is that the approach is new, but is this the very first time that such a strategy has been tested? If so, where did the idea come from? If not, what did previous studies of this approach find? A bit of background would have been useful.
The language used in the release does not appear to oversell the findings in the study.