Patients with Psoriasis Speak to the FDA

Research shows that psoriasis is much more than a skin condition. The complicated disease affects patients both physically—through an increasing list of comorbidities, such as cardiovascular disease, cancer, and type 2 diabetes. The disease also affects patients on an emotional level and has been linked to depression.

Figure 1. The FDA hosted a patient-focused meeting to learn more about life with psoriasis. People with psoriasis,
physicians, and members of the National Psoriasis Foundation came out to the meeting.

Recently, the FDA held a day-long patient-focused drug development (PFDD) meeting in which patients spoke to officials from the FDA about psoriasis and how it impacts their lives. The Dermatologist works closely with the National Psoriasis Foundation (NPF) through a collaborative partnership with the goal of increasing awareness and reporting on the latest psoriasis research. The patient perspective is an important element in the treatment of the disease.

Following is a reprint of an article that originally was published on the NPF website recounting the PFDD meeting and the reactions from patients who were in the audience or through the live webcast.

The FDA Heard Us Loud and Clear
The FDA hosted a patient-focused meeting to learn more about life with psoriasis and how patients feel about treatments. We gave them an earful, and now they want to know more.

Everyone living with psoriatic disease has their own opinion on the effectiveness, affordability, and potential side effects of their treatment options. So if you could be in a room with the FDA—the decision-makers behind which medications are made available to patients—what would you say?

Aimes Vasquez recently had that chance. She told them, “You name it, I’ve done it. I tried biologics. After a while, they stop working. I gave up hope thinking they were all the same. I just want a medication with no side effects that will give me total clearance.”

On March 17, the FDA held a day-long PFDD meeting focused exclusively on psoriasis. The goal was to collect patient perspectives on treatments and learn about the ways psoriasis impacts our everyday lives.

“We at the FDA are aware of unmet medical needs experienced by patients who have psoriasis,” said Jane Liedtka, MD, of the agency’s division of dermatology and dental products (DDDP) at the Center for Drug Evaluation and Research.

The FDA wants to know from patients how well they fare on treatments currently available in the marketplace, how symptoms of their disease—such as itch or plaques—affect their everyday lives, and whether alleviating some of these symptoms is worth the risk of the potential side effects noted on black box warnings.

“It is our responsibility to make sure the [benefits of] treatments outweigh the risks,” said DDDP Director Kendall Marcus, MD, who facilitated the meeting. “We look forward to incorporating what we learn today into the agency’s thinking.”


Figure 2. The FDA panel wanted to know how well patients fare on treatments available in the marketplace, how symptoms of their disease affect their everyday lives, and whether alleviating some of these symptoms is worth the risk
of the potential side effects noted on black box warnings.


FDA Recognizes Patient Needs
Psoriasis is 1 of only 24 diseases selected to be topics of these patient-focused meetings, which started in 2013 and will conclude sometime next year. HIV, breast cancer, Parkinson disease, and fibromyalgia are among the other PFDDs hosted by the agency.

“We’ve been busy laying the groundwork for this unprecedented meeting since fall 2014, when, in collaboration with the division at the FDA that reviews dermatology products, NPF brought leaders in the psoriatic disease field to a meeting attended by more than 40 FDA doctors, biostatisticians, epidemiologists, toxicologists, and other staff,” said Leah Howard, NPF vice president of government relations and advocacy. “When the FDA asked for recommendations for disease area topics, nearly 2700 people suggested more than 50 diseases. NPF and LEO Pharma proposed a psoriasis meeting, and the agency agreed on the need.”

The overwhelming response from patients across the country cemented that need. At final count, more than 140 people registered to attend the meeting in person and more than 200 people opted to participate online through a live webcast. The FDA later said it was the biggest response it has received from a patient disease community thus far.


Figures 3 and 4. Panel participants and audience members shared personal accounts of their psoriasis experience.


A Lasting Impression
The PFDD meeting was divided into 2 topics:

  • Disease symptoms and daily impacts
  • Patient perspectives on treatment approaches

For each topic, the FDA hosted a panel of patients who offered their personal stories and opinions. This was followed by a commentary period from patient members and caregivers in the audience, as well as individuals phoning in.

What resulted was a candid conversation about some of the hardships of living with this disease that most of us are too ashamed to discuss—from coping with genital psoriasis to being quarantined as children because people thought it was contagious.

The courage it took for panel participants and audience members to share such personal accounts not only unified the room, but at times, visibly affected members of the FDA, a relatively stoic-looking bunch whose facial expressions often gave way to sympathy and shock.

A resounding theme was what little the medications do to relieve the everyday nuances associated with the disease. “My experience is that the biologics have really helped but it never stops the itch,” Caleb Sexton said, adding, “I have single-handedly bankrupted my family trying to pay for my health care.”

At one point, the FDA asked how many people in the audience were itching or in pain at that very moment, and nearly everyone in the room raised their hand. “Based on the type of questions the FDA is asking, it really seems like they are listening to what we have to say,” Renee Andrews remarked.

By the Numbers
Throughout the meeting, FDA polled members of the audience and people participating online, and the results were reported in real-time. Here are some interesting takeaways:

  • Have you ever been diagnosed with psoriatic arthritis? 59% said yes
  • Where is your psoriasis located? 85% said scalp
  • What are the most bothersome impacts the disease has on your everyday life? 59% said emotional impacts
  • When considering a new treatment for psoriasis, which of the following benefits would you consider to be the most meaningful? 64% said reduced itching and flaking
  • Which 2 would you rank as most important to your decisions about using treatments to help reduce or control the spread of your psoriasis? 64% chose whether the drug showed effectiveness, 44% was access to treatment (such as insurance coverage), and 31% said possibility of rare but dangerous side effects. 

Ms Jones is the editor at the National Psoriasis Foundation in Portland, OR.