This report summarizes the input shared by patients and patient representatives during the meeting or through the webcast. It also includes a summary of comments submitted to the public docket. To the extent possible, the terms used in this report to describe specific psoriasis symptoms, impacts, and treatment experiences reflect the words used by in-person, web participants, or docket commenters. The report is not meant to be representative in any way of the views and experiences of any specific group of individuals or entities. There may be symptoms, impacts, treatments, or other aspects of the psoriasis that are not included in this report.
The input from the meeting and docket comments underscore the diversity in patients’ experiences with psoriasis. It also highlights the immense emotional and social toll the disease can exert on patients’ lives. Several key themes emerged from this meeting:
• Participants reiterated poignantly how psoriasis is much more than a skin rash. They described a debilitating chronic disease that places a significant burden on daily life and has a severe impact on how patients feel and function.
• Participants described the physical, social and emotional impact that living with psoriasis has had on their lives, including: limitations on activities, embarrassment, stigma, and social discrimination. Participants also commented on the destructive impact of psoriasis on multiple generations of their families.
• Participants shared their experiences with phototherapy and prescription and non-prescription medicines via various routes of administration, including topical, oral, intravenous, and intramuscular. Participants highlighted the varying degrees of success in managing their symptoms with these therapies. Participants also stressed the need to enhance the treatment armamentarium, given current challenges with variability in effectiveness, tolerability, access to available treatments, and uncertainty regarding long-term effects of available treatments. The discussion also highlighted the unmet medical need for more and better treatments for the pediatric population living with psoriasis.
The patient input generated through this Patient-Focused Drug Development meeting and the public docket comments strengthens FDA’s understanding of the burden of psoriasis on patients and the treatments currently used to treat psoriasis and its symptoms. FDA staff will carefully consider this input during the drug development process, including when advising sponsors on their drug development programs and when assessing products under review for marketing approval. For example, (Appendix 4) shows how this input may directly support our benefit-risk assessments for medical products under review. This input may also be of value to the drug development process more broadly. For example, it may be useful to drug developers as they explore treatments for pediatric psoriasis patients or as they define clinical endpoints related to itching, burning, pain, and other symptoms. It could also point to the potential need for development and qualification of new outcome measures in clinical trials, such as psoriasis at specific locations.
U.S. Food and Drug Administration (FDA)
Disease Category: Skin
Disease Name: Psoriasis
Age Range: Unknown
Sex:
Nature of Intervention:
- Patient perspectives