With two decades of experience managing and conducting clinical trials, Wendy Cantrell DNP, CRNP, knows the value of sponsored randomized controlled trials conducted to bring new medicines to market. She also understands the limitations.
“They exclude people that have concomitant diseases that are not managed well. They want a ‘healthy’ population, so that when the FDA looks at their data, it's clean and they don't have any surprises in the labels,” says Dr. Cantrell. As such, the data may not reflect the real world. “We know that psoriasis patients are heavy, they're overweight, their BMI is much higher than their healthy counterparts’. They have concomitant diseases, such as depression, metabolic syndrome, diabetes. They are more apt to have drug abuse, alcohol abuse, suicide attempts, because their disease impacts every aspect of their life.”
Increasingly, those who treat psoriasis recognize the need to evaluate each patient’s overall health and to conduct appropriate screenings. The challenge may come in clinical decision making based on the information gathered. “What happens in the real world when it doesn't fit that perfect cookie cutter psoriasis patient that was studied?” Dr. Cantrell asks.
“I think one reason that Advanced Practice Provides or APPs have such high patient satisfactions scores is because we talk a little bit more. We talk about the whole person.” As such, APPs can assess quality of life and often provide improvement in multiple aspects of the patient’s health—just by focusing on their skin. Data confirm that biologic therapy for psoriasis has a “real world” effect on multiple domains of quality of life. (Br J Dermatol 177(5):1410-1421)
“I like to talk to my patients regardless of whether I’m addressing depression or whether it's drug and alcohol abuse; my goal is to help them feel better, to have a significant, positive impact on their quality of life,” Dr. Cantrell says. “We have a positive impact on quality of life when patients are more confident about their appearance. They don't worry about the stigma of a skin disease and people wondering whether they're contagious or don't want them to swim in a pool or are willing to serve food to them. When you remove that, in combination with feeling better, they're sleeping better, they just have a better quality of life.”
As quality of life improves, Dr. Cantrell suggests, patients may experience improvement in other concomitant diseases, such as depression or the perceived need to self-medicate with alcohol or drugs. Patients may even become more active, decrease their BMI, and perhaps reduce the need for diabetes and/or cholesterol medications.
Dr. Cantrell emphasizes a goals-oriented approach. “I am very upfront with patients. I talk to them about risks. I like to tell them my goals, which are to improve their skin and get them as clear as possible. And with some of the medications that have been approved over the last three to five years, there's a pretty good possibility we might be able to get them 100 percent clear. I explain, ‘If we get you 100 percent clear, you might feel more like getting out, more like going to the gym to work out, more like exercising, eating better. You might not find the need to drink a couple of glasses of wine to sleep at night.’”
Etanercept and adalimumab—among the first biologics approved for psoriasis—have long term safety data available, and other agents are adding data over time. “The FDA is very clear that they want these companies to produce long-term data and when the drug is approved, the FDA actually gives them an idea of what they want them to study next for that drug and in what population,” Dr. Cantrell says. The phase 4, post-approval studies tend to be less restrictive, so the data add to prescribers’ comfort level, she suggests.
“The truth is that post-marketing data, post-approval data, is very robust,” Dr. Cantrell says, “so if a patient has a side effect, we collect that data. There is safety data collection going on even after approval.”