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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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Psoriasis patients are very poorly adherent to topical treatment. If adherence issues are ignored, poor adherence may limit the real-world efficacy of deucravacitinib, too. Forty psoriasis patients recruited from Wake Forest Baptist Health Dermatology Clinic will be enrolled. Twenty will be randomized to a reporting intervention designed to promote better adherence and the remaining 20 patients will serve as controls who will not receive a reporting intervention. Through qualitative interviews of the 40 patients recruited, we plan to study the behaviors of the most adherent patients to better understand specific beliefs and behaviors of adherent patients and to identify practical, modifiable factors that can improve adherence. We will also compare treatment outcomes and efficacy of deucravacitinib between the most and least adherence patients.
STUDY OBJECTIVES
PRIMARY OBJECTIVE: The primary objective of the proposed study is to identify adherence outliers (high and low adherence), specific beliefs, and behaviors that correspond to better and worse adherence to oral treatment of psoriasis.
SECONDARY OBJECTIVE: The investigators will study the efficacy and safety of deucravacitinib in patients who are highly adherent to treatment compared to patients who do not take the medication as directed (including both those who undertreat and overtreat).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | 50% of subjects will be randomized to a reporting tool designed to promote better adherence to treatment by having subjects report their progress on a weekly basis (the goal is not to test this tool but to help assure there is a broad range of adherence behavior including some positive adherence outliers) |
|
| No Intervention | No Intervention | 50% of subjects will not receive additional outreach to improve adherence |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text reminder | Behavioral | weekly text to remind use of drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Identify Adherence to treatment | Qualitative data will be obtained from detailed, systematic interviews at 3-month follow-up to Adherence to treatment will be captured using electronic monitors that record the timing of medication dosing events and the number of pills taken at each event (based on weight of medication using Sensal Health adherence monitoring device) measured at 3 month close-out visit | 3 month close-out visit |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Treatment Efficacy (PASI 75) | Compare psoriasis treatment outcomes between the most and least adherent patients The primary measure of efficacy for comparing efficacy between high vs low adherence subjects will be percent of subjects with 75% improvement in Psoriasis Area and Severity Index (PASI 75). | baseline and 3 month close-out visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Feldman, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences Department of Dermatology | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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All participants will receive their medication with electronic monitors attached. 50% of those enrolled will receive reminders to take their medication the other 50% will not.
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Participants will not be told that the monitors attached to their medication is recording their usage
| Psoriasis Treatment Efficacy (PASI 90) | Compare psoriasis treatment outcomes between the most and least adherent patients The primary measure of efficacy for comparing efficacy between high vs low adherence subjects will be percent of subjects with 90% improvement in Psoriasis Area and Severity Index (PASI 90). | baseline and 3 month close-out visit |
| Psoriasis Treatment Efficacy (PASI 100) | Compare psoriasis treatment outcomes between the most and least adherent patients The primary measure of efficacy for comparing efficacy between high vs low adherence subjects will be percent of subjects with 100% improvement in Psoriasis Area and Severity Index (PASI 100). | baseline and 3 month close-out visit |
| Disease Clarity - Investigator's Global Assessment (IGA) Scale | Compare psoriasis treatment outcomes between the most and least adherent patients The IGA is a five-point scale is a modified tool for evaluating plaque psoriasis severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. A decrease in score relates to an improvement in signs and symptoms. | baseline and 3 month close-out visit |