Evidence Impact on Biologics Confidence for Psoriasis

Overseen By Irma M Richardson, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Biologics

Disqualifiers: Under 18, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different types of information affect people's confidence in using biologic medications to treat moderate-to-severe psoriasis. Biologics can help reduce inflammation, but some people hesitate to use them due to fears or misconceptions. Participants will receive different types of information—anecdotal stories, scientific evidence, both, or none—to determine which increases their confidence in the treatment. This trial is ideal for individuals diagnosed with psoriasis who have never used biologic medications.

As an unphased trial, this study offers a unique opportunity to contribute to understanding patient perspectives and improving future treatment approaches.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who are currently or have previously been treated with biologic medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that biologic medications for psoriasis, such as ustekinumab and ixekizumab, are generally safe. One study found that these treatments have a good safety record, meaning they don't cause serious harm over time. Another study showed that anti-interleukin 23 agents, a type of biologic, rarely cause side effects. Additionally, these treatments do not seem to harm specific organs in the long run.

Overall, patients have tolerated biologics for psoriasis well. While some may experience side effects, these are usually not severe. This evidence suggests that biologics can be a safe option for treating moderate-to-severe psoriasis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to understand how different types of evidence impact patients' confidence in biologic treatments for psoriasis. Unlike other trials that focus on the treatments themselves, this one explores whether anecdotal evidence, research-backed information, or a combination of both influences patients' perceptions and decisions. This could lead to more effective communication strategies in healthcare, ensuring that patients feel more informed and confident in their treatment choices. Understanding these dynamics can ultimately enhance patient satisfaction and treatment adherence, which are critical for managing chronic conditions like psoriasis.

What evidence suggests that this trial's treatments could be effective for psoriasis?

This trial will compare different types of evidence impacting confidence in biologic treatments for psoriasis. Research has shown that biologic medications for psoriasis work very well. Studies indicate that biologics, such as anti-IL-17A drugs, quickly improve symptoms and enhance quality of life. A review of multiple studies found that all biologics are more effective than a placebo in treating moderate to severe psoriasis. Patients generally find biologic treatments more satisfying than other therapies. These medications target specific parts of the immune system to reduce inflammation. This evidence suggests that biologics are a strong option for effectively managing psoriasis. ^{3 4 6 7 8}

Who Is on the Research Team?

Steve R Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with psoriasis who have never been treated with biologic medications. It aims to understand if different types of evidence can boost their confidence in using these drugs.

Inclusion Criteria

I have been diagnosed with psoriasis.

Exclusion Criteria

I have been treated with biologic medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are exposed to different scenarios involving anecdotal and/or research study evidence about biologic medications

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in confidence regarding biologic medications

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anecdotal Evidence
• Anecdotal + Research Study Evidence
• No Evidence
• Research Study Evidence

Trial Overview The study tests whether presenting patients with clinical trial evidence, anecdotal evidence, both, or no evidence affects their confidence in the success of biologic medications for treating psoriasis.

How Is the Trial Designed?

Group I: Anecdotal + Research Study Evidence Active Control 1 Intervention

Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence and anecdotal evidence.

Group II: Anecdotal Evidence Active Control 1 Intervention

Scenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence.

Group III: Research Study Evidence Active Control 1 Intervention

Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence.

Group IV: No Evidence Placebo Group 1 Intervention

Scenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10595217/

Effectiveness of Biologics, Patient-Reported Outcomes, ... This subgroup analysis showed that anti-IL-17A biologics are effective at rapidly improving signs and symptoms of PsO and improving quality of life.

2. withpower.com withpower.com/trial/phase-psoriasis-5-2017-d632e

Evidence Impact on Biologics Confidence for Psoriasis Research shows that patients with psoriasis are generally more satisfied with biologic treatments, which are a type of advanced drug therapy, compared to non- ...

3. cdn.mdedge.com cdn.mdedge.com/files/s3fs-public/CT108002S020.PDF

Anecdote Increases Patient Willingness to Take a Biologic ... In this study, we aimed to evaluate patients' willingness to take a biologic medication for their psoriasis if presented with clinical trial evidence, an ...

4. dermatologyadvisor.com dermatologyadvisor.com/news/biologics-outperform-placebo-in-plaque-psoriasis/

Biologics Show Superior Efficacy in Moderate to Severe ... Results of a meta-analysis showed that all biologic agents were superior to placebo for improving short-term outcomes in moderate to severe ...

5. icer.org icer.org/wp-content/uploads/2020/10/NE_CEPAC_Psoriasis_Evidence_Report_FINAL_012317.pdf

Targeted Immunomodulators for the Treatment of Moderate ... 6.2 Prior Published Evidence on Costs and Cost-Effectiveness of Psoriasis ... Data were abstracted and summarized into evidence tables for all outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4345931/

Biologic Safety in Psoriasis: Review of Long-Term ... These biologic agents have demonstrated high efficacy and a favorable safety profile without evidence of cumulative organ-specific toxicity.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03168347

Assessing Patient Confidence in Biologic Medications The investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2133.2012.11207.x

Biologics for psoriasis: current evidence and future use The efficacy of biologics in plaque psoriasis is now generally accepted, with a number of studies reporting positive data for up to 3 years of ...