Text Reminders for Psoriasis Treatment Adherence

Overseen By Irma M Richardson, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Biologics, Systemics, Phototherapy

Disqualifiers: Severe comorbidities, Active malignancy, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{3 4 6 7 8}

How 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. ^{4 7 9 10 11}

Research Team

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility 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 have moderate-to-severe plaque psoriasis affecting my quality of life or certain body areas.

Approved birth control methods required for females of childbearing potential.

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.

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

Treatment Details

Interventions

• Text reminder

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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 Intervention Active Control 1 Intervention

50% of subjects will not receive additional outreach to improve adherence

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

In a 1-year open-label trial with seven patients, adherence to adalimumab treatment for moderate to severe psoriasis was found to be highly variable, indicating that some patients struggle significantly with following their treatment regimen.

The study highlights that adherence to injectable biologic medications like adalimumab is often poor, which can impact treatment outcomes, although the specific clinical consequences of this poor adherence are not yet fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to adalimumab in patients with moderate to severe psoriasis. West, C., Narahari, S., O'Neill, J., et al.[2022]

The Accountability Measurement Tool (AMT) has shown excellent reliability (Cronbach's alpha = 0.86) for assessing patient accountability in medication adherence among 30 adults with psoriasis.

The AMT demonstrated good convergent validity, correlating positively with factors like fear of negative evaluation and various forms of motivation, indicating it effectively measures accountability related to medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Accountability Measurement Tool in Patients with Psoriasis: A Validation Study. Su, JJ., Cline, A., Bashyam, AM., et al.[2021]

In a study of 8,524 psoriasis patients, ustekinumab showed the lowest discontinuation rate (48.4%) and the highest persistence (59.8%) compared to other treatments like adalimumab and apremilast over a 12-month follow-up period.

Patients on ustekinumab also had significantly better adherence, with 81.8% achieving a medication possession ratio (MPR) of ≥80%, compared to lower rates for adalimumab (67.9%) and other medications, indicating ustekinumab may be a more effective long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment adherence and persistence of five commonly prescribed medications for moderate to severe psoriasis in a U.S. commercially insured population. Wu, B., Muser, E., Teeple, A., et al.[2022]

In a study of 22,742 new psoriasis patients using systemic medications, adherence to biologic treatments like adalimumab, etanercept, and ustekinumab was significantly higher compared to methotrexate, indicating these options may be more effective in ensuring patients stick to their treatment plans.

Conversely, adherence to acitretin was notably lower than methotrexate, suggesting that this medication may not be as well-received or effective in maintaining patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug utilization patterns and adherence in patients on systemic medications for the treatment of psoriasis: A retrospective, comparative cohort study. Dommasch, ED., Lee, MP., Joyce, CJ., et al.[2021]

In a study of 106 psoriasis patients, self-reported treatment adherence was high at 85.8%, with biologic therapies showing the highest adherence rate at 100%, followed by oral therapies at 96%, phototherapy at 93%, and topical treatments at 75%.

Factors negatively impacting adherence included being too busy, feeling fed up with treatment, and the messiness of topical therapies, highlighting the importance of treatment convenience and patient engagement in managing psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors affecting adherence to treatment of psoriasis: comparing biologic therapy to other modalities. Chan, SA., Hussain, F., Lawson, LG., et al.[2018]

Deucravacitinib, a selective tyrosine kinase 2 inhibitor, was found to be safe and well tolerated in a study involving 40 healthy Chinese subjects, with no serious adverse events reported.

The drug showed rapid absorption and a dose-dependent increase in systemic exposure, indicating that it effectively reaches the bloodstream and maintains consistent pharmacokinetics across different doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. Jing, S., Lin, Y., Dockens, R., et al.[2023]

A study involving 163 psoriasis patients revealed that treatment preferences significantly vary based on comorbidities, with those having psoriatic arthritis prioritizing the probability of treatment benefits, while those with cardiovascular disease were more concerned about the likelihood of side effects.

Patients with depression placed high importance on treatment duration and individual cost, indicating that addressing these preferences could enhance treatment adherence and overall care for psoriasis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidities significantly impact patients' preferences for psoriasis treatments. Schmieder, A., Schaarschmidt, ML., Umar, N., et al.[2022]

Deucravacitinib, an oral medication for moderate to severe plaque psoriasis, demonstrated higher PASI 75 response rates compared to apremilast and methotrexate across all time points in a network meta-analysis of 47 randomized controlled trials.

Long-term efficacy of deucravacitinib was comparable to first-generation biologics like adalimumab and ustekinumab, making it a viable oral treatment option for patients seeking effective psoriasis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. Armstrong, AW., Warren, RB., Zhong, Y., et al.[2023]

Only 35.7% of the 767 analyzed topical prescriptions for psoriasis met the criteria for high-quality prescriptions, indicating a significant issue with clarity and completeness in treatment instructions.

The quality of prescriptions was notably better when written electronically (3 times more likely to be high quality) and by dermatologists compared to general practitioners, suggesting that improving prescription methods could enhance patient adherence and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are we giving patients enough information on how to use topical treatments? Analysis of 767 prescriptions in psoriasis. Pouplard, C., Gourraud, PA., Meyer, N., et al.[2015]

In a study of 193 US adults with psoriasis, 71% reported a moderate to extremely high impact of the disease on their quality of life, highlighting the significant burden of psoriasis.

About 50% of respondents who did not adhere to their treatment cited forgetfulness as a reason, indicating that improving patient education and communication could enhance adherence and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease burden and treatment adherence in psoriasis patients. Feldman, SR.[2015]

In a study of 201 psoriasis patients, the overall medication adherence was found to be 60.6%, with significant factors influencing compliance including being female, married, employed, and not having to pay for prescriptions.

There was a strong negative correlation (r = -0.92) between medication adherence and the Dermatology Life Quality Index (DLQI), indicating that lower quality of life is associated with poorer adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective assessment of compliance with psoriasis treatment. Zaghloul, SS., Goodfield, MJ.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adherence to adalimumab in patients with moderate to severe psoriasis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Accountability Measurement Tool in Patients with Psoriasis: A Validation Study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Treatment adherence and persistence of five commonly prescribed medications for moderate to severe psoriasis in a U.S. commercially insured population. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Drug utilization patterns and adherence in patients on systemic medications for the treatment of psoriasis: A retrospective, comparative cohort study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Factors affecting adherence to treatment of psoriasis: comparing biologic therapy to other modalities. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Comorbidities significantly impact patients' preferences for psoriasis treatments. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Are we giving patients enough information on how to use topical treatments? Analysis of 767 prescriptions in psoriasis. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Disease burden and treatment adherence in psoriasis patients. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Objective assessment of compliance with psoriasis treatment. [2022]