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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

In dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Examples of biologic medications commonly used in dermatology include tumor necrosis factor-alpha (TNF-alpha), blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17A blockers (secukinumab, ixekizumab). Due to biologic medication's efficacy and safety profiles, they have revolutionized dermatology and the general medical field. However, patients may be apprehensive about choosing a biologic medication for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media. Many patients are not aware that clinical trial evidence for biologics exist, and instead may rely on anecdotal evidence in choosing to take these medications. Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. Physicians must be able to ascertain from where the fear originates and how it can be countered. By understanding what kind of information will allow patients to be confident in their decision to take a biologic, dermatologists can improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or adverse events may improve adherence to treatment and may improve treatment outcomes. The investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating their psoriasis after being presented with clinical trial evidence, anecdotal evidence, or both.

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.

What evidence supports the effectiveness of the treatment Anecdotal Evidence, Anecdotal + Research Study Evidence, No Evidence, Research Study Evidence 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-biologic treatments. This satisfaction is linked to better quality of life and less severe disease symptoms. ^{1 2 3 4 5}

What safety data exists for biologic treatments for psoriasis?

Biologic drugs for psoriasis have been studied for safety, showing that some patients experience adverse events (side effects) or serious adverse events. In a study, 16% of patients had side effects, and 1% had serious side effects, with some drugs like secukinumab showing no adverse events in the study period. ^{6 7 8 9 10}

How does the biologic drug for psoriasis differ from other treatments?

Biologic drugs for psoriasis are unique because they target specific parts of the immune system, which can lead to clearer skin for longer periods compared to traditional treatments like methotrexate. Patients using biologics often feel more accepting of their necessity and experience fewer concerns about side effects, making them a preferred option for those seeking long-term relief. ^{6 11 12 13 14}

Research Team

Steve R Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Patient Preferences for Treatment of Psoriasis with Biologicals: A Discrete Choice Experiment. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Treatment patterns and therapy effectiveness in psoriasis patients initiating biologic therapy in England. [2018]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-reported treatment satisfaction and choice of dosing frequency with biologic treatment for moderate to severe plaque psoriasis. [2022]

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

Determinants of patient and physician treatment satisfaction in moderate-to-severe psoriasis: a multinational survey of psoriasis patients. [2022]

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

Patient preferences for psoriasis treatments: impact of treatment experience. [2022]

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

Anecdote Increases Patient Willingness to Take a Biologic Medication for Psoriasis. [2022]

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

Adverse events resulting in withdrawal of biologic therapy for psoriasis in real-world clinical practice: A Canadian multicenter retrospective study. [2019]

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

Presenting treatment safety data: subjective interpretations of objective information. [2017]

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

Comparison of Drug Discontinuation, Effectiveness, and Safety Between Clinical Trial Eligible and Ineligible Patients in BADBIR. [2019]

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

Safety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Uncovering the unmet needs among psoriasis patients in the Asia-Pacific region. [2022]

12. Italy pubmed.ncbi.nlm.nih.gov

Biologic agents perception in patients attending for the first-time to psoriasis centers: a multicenter Italian survey. [2021]

13. England pubmed.ncbi.nlm.nih.gov

The journey of adult psoriasis patients towards biologics: past and present - Results from the BioCAPTURE registry. [2018]

14. Sweden pubmed.ncbi.nlm.nih.gov

Beliefs About Medicines in Patients with Psoriasis Treated with Methotrexate or Biologics: A Cross-sectional Survey Study. [2019]