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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to help people adhere to their psoriasis treatment using Otezla, a medication that manages symptoms. Researchers aim to determine if regular reminders or an initial consultation about the medication can improve patient adherence to treatment plans. The trial targets adults diagnosed with mild psoriasis who have been recommended to use Otezla. Participants will be divided into groups, with some receiving reminders or consultations, to identify which method best supports ongoing treatment adherence. As an Early Phase 1 trial, this research focuses on understanding the effectiveness of these support methods in promoting treatment adherence.

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.

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

Research has shown that Otezla (apremilast) is generally safe for people. Studies have found that many patients tolerate it well. In long-term studies lasting up to five years, Otezla maintained a good safety record for conditions like psoriasis and psoriatic arthritis, with most people not experiencing serious side effects.

Common side effects include nausea, diarrhea, and headache, but these are usually mild and temporary. It is important to note that Otezla should not be used by anyone allergic to apremilast or its ingredients.

Overall, Otezla has a well-established safety record, which can reassure those considering it as a treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these adherence strategies combined with Otezla for psoriasis because they aim to enhance how well patients stick to their treatment plans. Otezla itself is already known for its unique mechanism of action, targeting specific molecules involved in inflammation, but what's different here is the focus on improving patient adherence. The trial explores three innovative approaches: using electronic monitoring to track medication use, sending reminder texts or emails, and offering initial patient consultations for education. These strategies could lead to better treatment outcomes by ensuring patients consistently take their medication, potentially improving their quality of life.

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

Research has shown that Otezla (apremilast) can effectively reduce psoriasis symptoms. One study found that 68.4% of patients experienced at least a 50% improvement in their psoriasis after six months, and 35.1% saw a 75% improvement. In this trial, participants in different arms will receive adherence strategies to enhance treatment effectiveness. One arm will include reminder texts, which studies have shown help people stick to their treatment plans. Another arm will involve an initial patient consultation focusing on medication education. These strategies might help maintain the benefits of Otezla by ensuring patients continue their treatment. ^{3 5 6 7 8}

Who Is on the Research Team?

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Science

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05601492

Study Details | NCT05601492 | Adherence to Otezla As a secondary outcome, we will compare psoriasis treatment outcomes (efficacy) between the most and least adherent patients. Measures for comparing efficacy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8866388/

Real-Life Effectiveness of Apremilast for the Treatment ... As assessed by the physician, 68.4% and 35.1% of patients achieved at least a 50% and 75% reduction in PASI, respectively, at month 6.

3. fda.gov fda.gov/media/180626/download

NDA/BLA Multi-Disciplinary Review and Evaluation (Otezla) The Applicant conducted and submitted the results of the following two clinical studies issued as PREA PMRs and Written Requests (WR), following.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12126424/

Efficacy and Safety of Apremilast Over 52 Weeks in ... Improvements in QoL, itch, skin discomfort/pain, patient-reported treatment benefits, and skin outcomes at week 16 were maintained over 52 weeks ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03097003

A Study of the Real-life Management of Psoriasis Patients ... As per NIHDI recommendations, patients should consult their treating dermatologists 6 months after apremilast initiation in order to evaluate treatment response ...

6. otezlapro.com otezlapro.com/plaque-psoriasis/safety/

PsO Safety Profile | Otezla® (apremilast) HCP The safety profile for Otezla was studied in 7 clinical trials across mild to moderate and moderate to severe plaque psoriasis.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4517531/

Apremilast (Otezla): A New Oral Treatment for Adults With ... SAFETY PROFILE. While the long-term extension studies and post-marketing reports will ultimately shed more light on the overall safety of apremilast, the data ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01690299

Phase 3b Safety and Efficacy Study of Apremilast to Treat ... This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of ...