Clinical trials test complicated drugs or devices, but their goals are simple: To find out if a particular treatment is effective and safe.
Clinical trials (also known as “studies”) come in all shapes and sizes, but one thing they all share is a phase. Clinical trials move through phase 1, phase 2 and phase 3 on their way to winning approval from the U.S. Food and Drug Administration (FDA).
One way to think of clinical trials is to borrow the metaphor of a baseball season. Players gather in spring training to exercise and work on their skills. Some players will make the team; others will go back to the minors. That’s something like phase 1.
The season begins and each team observes its players. Who’s doing well in center field? Who should we try out at a new position? That’s phase 2.
Later in the season, some teams are doing better than others. Some teams will go to the playoffs and maybe the World Series. That’s phase 3.
Throughout the year, dermatologists and rheumatologists gather at conferences to learn the latest research in psoriasis and psoriatic arthritis. Because it’s a good time to see how all those clinical trial players are doing, these conferences often feature the latest clinical trial information from drugs in development.
In September 2016, new clinical trial data from several drugs in development was released during the European Academy of Dermatology and Venereology annual meeting in Vienna.
We’d like to present some of that data from four drugs in the clinical trial phase being tested for psoriasis as part of our ongoing effort to report on current research and drug development.
These are biologic drugs. Biologics are taken by injection or infusion. They attempt to rein in overactive cytokines, or proteins, that stimulate an immune response that results in inflammation.
Tildrakizumab was designed to block a specific cytokine: interleukin-23 (IL-23). Sun Pharma, the company that is developing tildrakizumab, announced the latest results of its phase 3 studies in psoriasis.
According to the data, 77 percent of the people in the trials achieved 75 percent skin clearance after 28 weeks.
Serious side effects (what researchers call “adverse events”) occurred in 1 percent to 3 percent of the patients, according to the report.
Guselkumab, like tildrakizumab, targets the cytokine IL-23. Janssen, the maker of guselkumab, reported on phase 3 data for psoriasis that compares guselkumab with AbbVie’s Humira (adalimumab). Humira targets tumor necrosis factor-alpha (TNF-alpha), a different cytokine.
After 16 weeks of treatment, nearly 75 percent of the people receiving guselkumab achieved 90 percent improvement in their psoriasis compared with about half for the people receiving Humira, according to results released by Janssen.
Approximately half of all people in the clinical trials reported at least one adverse event. Serious adverse events were reported in less than 3 percent of everyone in the trial.
Cimzia (certolizumab pegol)
Cimzia was approved by the FDA in 2013 for the treatment of psoriatic arthritis. It targets the cytokine TNF-alpha. It’s not currently approved for the treatment of psoriasis, which is what this clinical trial is all about.
At week 16 of a phase 3 study testing Cimzia in psoriasis, more than 80 percent of the people taking Cimzia achieved a 75 percent improvement in psoriasis, according to the statement from UCB and Dermira, the companies that make Cimzia.
The rates of adverse events in these trials were similar to what has been seen when using Cimzia to treat other conditions, the statement reported. For example, in clinical trials testing Cimzia for rheumatoid arthritis, about 5 percent of people taking Cimzia had to stop because of adverse events.
Cosentyx, which targets the cytokine IL-17A, was approved by the FDA in 2015 for the treatment of psoriasis and in 2016 for the treatment of psoriatic arthritis. Novartis, the maker of Cosentyx, released long-term phase 3 data for Cosentyx studying the drug over four years.
According to the data, almost 62 percent of patients achieved 90 percent improvement after three years. After four years, it was about two-thirds of patients.
At year four, about 15 percent of people in the trial had experienced common non-serious adverse events, according to the statement from Novartis.
Further reading on clinical trials
Remember: Even if a drug does come to market, it might not be right for you. What works for one person might not work for another. Meanwhile, consider participating in a clinical trial yourself. Consult the links below for more information, or contact NPF’s Patient Navigation Center.
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