Adherence Strategies + Otezla for Psoriasis

Overseen By Irma M Richardson, MHA

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Wake Forest University Health Sciences

Must be taking: Otezla

Disqualifiers: Under 18, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

84 Participants Needed

Trial Summary

What is the purpose of this trial?

Most people with psoriasis have very limited disease, yet that disease may still have a large impact on their lives. While limited psoriasis may be amenable to topical treatment, patients are exceptionally poorly adherent to topical treatment, especially over the long run.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Otezla for psoriasis?

Research shows that patients with psoriasis who have good adherence to their medication, like Otezla, tend to have better treatment outcomes and higher satisfaction. Additionally, personalized consultations and reminder interventions can improve adherence, potentially enhancing the effectiveness of the treatment. ^{1 2 3 4 5}

Is Otezla (apremilast) safe for treating psoriasis?

The safety of systemic treatments for psoriasis, including biologic drugs like Otezla (apremilast), has been studied in various registries. These studies generally show that these treatments have a satisfactory safety profile, with low rates of serious adverse events such as infections, heart problems, and cancer. ^{1 6 7 8 9}

How does the drug Otezla differ from other psoriasis treatments?

Otezla (apremilast) is unique because it is an oral medication, unlike many other psoriasis treatments that are injected or applied topically. It works by inhibiting an enzyme called phosphodiesterase 4 (PDE4), which helps reduce inflammation in the body. ^{1 10 11 12 13}

Research Team

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Science

Eligibility Criteria

This trial is for adults over 18 with a mild psoriasis diagnosis who have been recommended Otezla. Participants must speak English and not be pregnant to qualify.

Inclusion Criteria

I have been diagnosed with mild psoriasis and recommended Otezla.

Non-pregnant

English speaking

Exclusion Criteria

Non-English speaking

I do not have a diagnosis of mild psoriasis.

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the medication with an electronic monitoring cap and may receive interventions such as reminder texts or initial patient consultation to promote adherence

6 months

Regular visits as per standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Extended Consultation for apremilast
• Otezla
• Reminder Text Intervention with apremilast

Trial Overview The study tests if reminder texts or extended consultations improve adherence to the psoriasis medication Otezla, compared to standard care without these interventions.

Participant Groups

Group I: Arm 3 - Initial patient consult Experimental Treatment 1 Intervention

Participant will be given the medication with an electronic monitoring cap attached and will receive an initial patient consultation intervention, which will focus on the prescribed medication education and setting expectations of what to anticipate with usage of the medication

Group II: Arm 2 - Reminder text Experimental Treatment 1 Intervention

Participant will be given the medication with an electronic monitoring cap attached and receive weekly electronic text/email-based reporting intervention that is designed to promote better adherence to treatment (to help assure that the study have subjects who have excellent adherence. Having patients report their progress on a regular basis promotes better treatment adherence, perhaps by creating the same sense of accountability promoted by regular office visits

Group III: Arm 1 - Standard of Care Active Control 3 Interventions

Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Findings from Research

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]

Collaboration among psoriasis registries in the PSONET network enhances the ability to assess long-term treatment safety by providing larger and more diverse datasets, which is crucial for understanding the effects of treatments.

However, significant challenges exist in synthesizing data due to differences in how registries code adverse events, sample populations, and manage operational governance, which can complicate collective data interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges for synthesising data in a network of registries for systemic psoriasis therapies. Ormerod, AD., Augustin, M., Baker, C., et al.[2013]

In a study involving 2845 patients and 8954 treatment cycles, ustekinumab and secukinumab were found to have the lowest rates of adverse events compared to other systemic drugs for psoriasis, indicating a safer profile for these treatments.

Conversely, cyclosporine and infliximab were associated with the highest rates of adverse events, suggesting that these medications may carry more risks for patients with moderate to severe psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. Daudén, E., Carretero, G., Rivera, R., et al.[2021]

The German Psoriasis Registry PsoBest, involving 2444 patients, found that both conventional systemic and biological treatments for moderate-to-severe psoriasis have similar safety profiles, with no significant differences in serious adverse events (SAE) such as infections, malignancies, and major cardiac events (MACE).

The overall rate of serious adverse events was low, at 1.3 per 100 patient years for conventional drugs and 1.5 for biologics, indicating that both treatment types are safe for long-term use in routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest. Reich, K., Mrowietz, U., Radtke, MA., et al.[2018]

References

1. 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]

2. 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]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Assessment of medication adherence and treatment satisfaction in Japanese patients with psoriasis of various severities. [2018]

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

Improving psoriasis patients' adherence to topical drugs: a systematic review. [2020]

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Challenges for synthesising data in a network of registries for systemic psoriasis therapies. [2013]

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

Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Comparison of drug survival rates for adalimumab, etanercept and infliximab in patients with psoriasis vulgaris. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Development of an adherence-enhancing intervention in topical treatment termed the topical treatment optimization program (TTOP). [2021]

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

Adherence to ustekinumab in psoriasis patients. [2022]

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

Adherence to medication in patients with psoriasis: a systematic literature review. [2022]