This relatively thorough news release summarizes the results of a 24-week randomized trial of the biologic drug ixekizumab (marketed as Taltz) in patients with psoriatic arthritis. While the release hits most of the key points that any journalist might ask when writing about this study, it offers too little discussion of harms and no mention of the drug’s cost.
People with psoriatic arthritis often have painful, red, scaly patches on their skin and they may not be effectively treated with TNF inhibitors (drugs commonly used to treat inflammatory conditions). If only half of psoriatic arthritis patients get better with TNF inhibitors then another option would be most welcome for those that have found no relief.
The drug under study, ixekuzumab, appears to be effective in reducing symptoms of joint tenderness and swelling, and if it can provide these benefits at a reasonable level of safety, this could be a great advance. At the same time, if the goal of treatment is to prevent long-term complications of psoriatic arthritis (severe joint and bone damage and functional disability), we are still left wondering if this potential new treatment represents a benefit beyond 6 months for psoriatic arthritis sufferers.
No cost information was provided, even though the drug is already on the market for another condition. According to GoodRx, one 80 mg auto-injector of the drug costs around $4,700.
We are told that “19.5 percent of patients who received only the placebo injections were judged to have met the trial’s specified clinical endpoint — at least a 20 percent reduction in the number of tender and swollen joints — the response rate among those getting the real drug every four weeks was 53.3 percent. Those getting the drug every two weeks didn’t do any better and were slightly more prone to side effects, such as a mild reaction at the injection site.”
This is an adequate discussion of the drug’s benefits.
We learn that “few serious adverse events were reported for patients receiving the drug, or the placebo” but a close reading of the actual abstract shows that 7 percent of patients taking the drug every two weeks (versus 3 percent on placebo) had serious adverse events. If the absolute effects on benefits are reported why are not the absolute effects of the harms? We think it is important to at least list the major adverse events that occurred during the trial.
We learn that this is a randomized, blinded, three-armed, multi-site study that lasted 24 weeks, which is a sufficient description of the quality of evidence. We wish the release had mentioned that it remains uncertain how patients on the drug would fare long-term, beyond the 6 months of the trial.
There is no disease mongering. The release provides strong context on the condition as well as how the drug is believed to work.
The release states that the manufacturer paid for the trial and the key spokesperson, the principle investigator served as a consultant to Eli Lilly.
There was a good explanation about the alternatives — drugs like the TNF inhibitors already on the market such as adalimumab, etanercept and infliximab — but that “only about half of psoriatic arthritis patients who are given TNF inhibitors get better.” We also learn that “another approved monoclonal-antibody that targets IL-17, secukinumab, was approved in 2016 for psoriatic arthritis.”
The release notes that the drug has been FDA approved and is available for patients with psoriasis and that Lily has applied for FDA approval for use in patients with psoriatic arthritis as well.
The release does an acceptable job of describing the drug’s place in the treatment landscape. It does not make an outward claim of novelty, but it appears to be the first such randomized trial for this type of arthritis.
There are no examples of unjustified language.
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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