Text Reminders for Psoriasis Treatment Adherence
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Must not be taking: Biologics, Systemics, Phototherapy
Disqualifiers: Severe comorbidities, Active malignancy, Depression, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, specifically biologics, systemic treatments for psoriasis, and phototherapy.
What data supports the effectiveness of the drug Sotyktu (Deucravacitinib) and text reminders for psoriasis treatment adherence?
The research highlights that poor adherence to psoriasis treatments, including systemic medications, often leads to treatment failure. While specific data on Sotyktu (Deucravacitinib) is not provided, using text reminders could potentially improve adherence by helping patients remember to take their medication regularly.
12345Is Deucravacitinib safe for humans?
Deucravacitinib has been studied for safety in healthy subjects, and it was generally well-tolerated, meaning it didn't cause serious side effects in those who took it.
34678How does the text reminder treatment for psoriasis differ from other treatments?
The text reminder treatment for psoriasis is unique because it focuses on improving adherence to existing treatments by sending patients reminders to take their medication, addressing the common issue of forgetfulness that leads to nonadherence. This approach is different from traditional treatments that primarily focus on the medication itself, rather than supporting patients in consistently using their prescribed therapies.
4791011Eligibility Criteria
This trial is for adults with moderate-to-severe plaque psoriasis who speak English and can use approved birth control if necessary. They must have a TB test done at baseline. People with other skin conditions, pregnant or breastfeeding women, those without this type of psoriasis, under 18s, patients with severe health issues or cancer in the last 5 years, on certain other psoriasis treatments, or with recent substance abuse problems cannot join.Inclusion Criteria
Subject must have a working knowledge of English.
I am 18 years old or older.
I have moderate-to-severe plaque psoriasis affecting my quality of life or certain body areas.
+2 more
Exclusion Criteria
I do not have moderate-to-severe plaque psoriasis.
I am under 18 years old.
I do not have any severe or unstable health conditions.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive deucravacitinib and are monitored for adherence through a reporting tool and qualitative interviews
12 weeks
Weekly progress reports
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests whether text reminders can help people stick to their treatment plan for deucravacitinib better than no reminders. Forty patients will be split into two groups: one receiving reminders and the other not. The study aims to understand what makes someone more likely to follow their treatment and compare how well the drug works between these two groups.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
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)
Group II: No InterventionActive Control1 Intervention
50% of subjects will not receive additional outreach to improve adherence
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest University Health Sciences Department of DermatologyWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
References
Adherence to adalimumab in patients with moderate to severe psoriasis. [2022]Background The chronic and relapsing course of psoriasis is often associated with poor adherence to treatment. Adherence to topical treatment is abysmal. Adherence to systemic treatments also decreases over time, with an overall adherence rate of 67% for injectable biologic medications. Whereas overall trends in poor adherence have been documented, the fine details of adherence in individual patients is not well characterized. Purpose To assess adherence to adalimumab in patients with moderate to severe psoriasis. Methods Data on adherence were obtained from a 1-year open label trial including seven patients with moderate to severe psoriasis who agreed to participate in a randomized trial of standard physician education materials plus extended nurse education versus standard physician education materials alone. Adherence to treatment was recorded with electronic monitoring via Medication Event Monitoring System (MEMS) caps undisclosed to the patients. Patients were also instructed to note the time and date they used treatment in a journal. Results The subjects exhibited a broad range of adherence behaviors. Conclusions Adherence to adalimumab therapy for moderate-to-severe psoriasis is variable and can be very poor. The clinical impact of poor adherence to injectable biologic medications is not yet well characterized.
Evaluation of Accountability Measurement Tool in Patients with Psoriasis: A Validation Study. [2021]The role of accountability in promoting patient adherence to medication is not well characterized. An accountability measurement tool (AMT) has been developed to quantify accountability but has not been investigated for use with patients with skin disease. We aim to test the reliability and validity of the AMT for patients with psoriasis.
Treatment adherence and persistence of five commonly prescribed medications for moderate to severe psoriasis in a U.S. commercially insured population. [2022]To evaluate medication discontinuation, persistence, and adherence of moderate to severe psoriasis patients treated with adalimumab, apremilast, etanercept, secukinumab, and ustekinumab.
Drug utilization patterns and adherence in patients on systemic medications for the treatment of psoriasis: A retrospective, comparative cohort study. [2021]Nonadherence to systemic treatments for psoriasis leads to treatment failure and increased health care utilization.
Factors affecting adherence to treatment of psoriasis: comparing biologic therapy to other modalities. [2018]This study evaluated self-reported patient adherence to different types of treatment in psoriasis and factors that affect adherence.
Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, blocks cytokine signaling involved in psoriasis pathogenesis. This ethnic-bridging study evaluated deucravacitinib pharmacokinetics, tolerability, and safety in healthy Chinese subjects.
Comorbidities significantly impact patients' preferences for psoriasis treatments. [2022]Non-adherence rates are high among patients with psoriasis, partly because of discordance between recommended treatments and individual preferences.
Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. [2023]Deucravacitinib, a newly approved oral medication for the treatment of patients with moderate to severe plaque psoriasis, demonstrated efficacy versus apremilast and placebo in two phase 3 randomized controlled trials (RCTs). A systematic review and network meta-analysis (NMA) indirectly compared deucravacitinib with other relevant systemic biologic/nonbiologic treatments.
Are we giving patients enough information on how to use topical treatments? Analysis of 767 prescriptions in psoriasis. [2015]Unclear instructions probably contribute to the suboptimal efficacy and adherence to topical agents in psoriasis.
Disease burden and treatment adherence in psoriasis patients. [2015]Psoriasis can have a large impact on a patient's quality of life, yet adherence to psoriasis treatment often is poor. A large international study was conducted in adults with psoriasis and/or psoriatic arthritis to characterize the disease burden of psoriasis and its relationship to treatment adherence using a detailed, self-administered questionnaire. The results presented in this article represent the subset of US respondents who were currently taking prescription medication (N=193). The impact of psoriasis was graded as moderate to extremely high by 71% of US survey respondents. Among the respondents who did not adhere to prescribed treatments, approximately 50% attributed their nonadherence to forgetfulness and reported using the medication when they deemed it necessary. Respondents expressed a strong willingness to adhere to medications that were effective and to try multiple new treatments to find an optimal therapy. Of the respondents who were currently taking prescription medication, 88% were using topical therapies. The greatest unmet needs associated with topical psoriasis treatment were identified as fewer side effects, more rapid onset of action, and increased efficacy. The majority of respondents described positive relationships with their physician and a positive outlook with regard to physician communication, indicating an opportunity for the physician to directly influence patients' perceptions of disease burden and quality of life. When treating psoriasis with topical therapies, physicians should focus on improving and maintaining patients' quality of life, as this practice can be expected to improve treatment adherence and efficacy.
Objective assessment of compliance with psoriasis treatment. [2022]To assess patient compliance with psoriasis treatment.