The PSI is a self-administered patient-reported outcome measure (PRO) intended for use in assessing symptom severity in chronic plaque psoriasis. It has been developed in accordance with FDA Guidelines for Content Validity and Instrument Performance. It has been used in multiple clinical trials and has supported one label claim with the FDA.
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The PSI is an 8-item symptom severity scale that was originally developed to assess patient perceived symptom severity as an endpoint in clinical trials. Clinician feedback during the development process indicated high interest in the usefulness of this measure in the normal care settings as well.
The PSI has been developed and tested using both a paper/pencil “past 7-day” recall version for normal care settings, and a “past 24 hours” recall version (collecting 7 days of data and generates a weekly score) that was designed and tested for use with ePRO devices for clinical trial endpoints. The “past 7-day” recall version can also be used on tablet or hand held ePRO administration depending on the needs of the study design.
Evidera is the contracted agency approved by the PSI copyright holder (Amgen) to license and distribute the PSI for use. Our responsibility includes the protection of the integrity of the PSI as it is distributed for use, including development of translations, adaptations, and preparation for use in ePRO platforms.
A user agreement is required for all requests to use the PSI in research. Use is granted for a single study only. Fees for licensure vary depending on the type of user making the request and nature of the research. To inquire about terms and fees for licensure to use the PSI, please click on your affiliation below for the correct form to submit with your inquiry and an Evidera project manager will get back to you with information relevant to your needs.
Academia or private practice Pharmaceutical or commercial research PSI partnership company
Current lists of the available languages can be found below:
Resources available include a reference list of citations currently available, showing use and performance of the PSI, and a user manual covering the development of the PSI and its scoring.
The PSI is supported by 23 different professional publications and scientific presentations.
PSI Publications & Presentations
The PSI User Manual provides an overview of the development and validation studies for the PRO and describes the scoring method and provide scoring syntax. It is available with each completed license for use of the PSI.
SILIQ™ (brodalumab) injection, for subcutaneous use
Initial U.S. Approval: 2017
14 CLINICAL STUDIES
At week 12, compared to subjects in the placebo group, a greater proportion of subjects in SILIQ 210 mg Q2W group achieved a Psoriasis Symptom Inventory (PSI) score of 0 (not at all) or 1 (mild) on every item (itch, redness, scaling, burning, stinging, cracking, flaking, pain).
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