Psoriasis Clinical Trials Aim to Improve Disease Management, Drug Adherence

Psoriasis is an immune-mediated inflammatory disease, with a chronic relapsing-remitting course, which affects 2–3% of the worldwide population.1 Its effect ranges in severity from a few scattered red, scaly plaques to involvement of almost the entire body surface.2 Psoriasis may progressively worsen with age, or wax and wane in its severity. It is associated with cardiovascular disease, depressive illness, and psoriatic arthritis.3

This blog provides a brief overview of medication adherence in psoriasis, a snapshot of the psoriasis clinical trial landscape, and a look at technology used to improve dosing performance in psoriasis clinical research.4

Real-world medication adherence rates in psoriasis are low and many patients do not persist with treatment.5 Using commercial and Medicare claims databases to study marketed psoriasis therapeutics over a 24-month period following initiation, researchers found medication adherence rates at 12 months ranged from 30% to 54%; at 18 months, 25% to 40%; and at 24 months, 21% to 33%.6 Adherence was measured as the proportion of days covered being greater than or equal to 0.8.7

Traditional interventions to improve adherence are complex and not widely effective.8 To improve suboptimal adherence rates in adults with chronic diseases such as psoriasis, researchers have examined mobile applications as a scalable means to support patients.9 The first systematic review and meta-analysis of the efficacy of mobile apps for medication adherence in patients with chronic disease was published in 2020.10 Fourteen studies were included in this systematic review involving 1,785 participants, 940 of whom were randomized to a mobile app intervention group and 845 to the usual care group.11 The meta-analysis showed that the use of mobile apps was associated with a significant improvement in patient adherence to medication (Cohen’s d = 0.40, 95% CI = 0.27-0.52; P < 0.001), albeit with a low quality of GRADE evidence.12

Emerging approaches

The number of treatment options for psoriasis has grown over the past two decades as understanding of the disease has evolved. Biologic agents targeting specific components of the interleukin (IL)-23/IL-17 pathway have proven successful in promoting skin clearance among patients.13 However, their use is often limited owing to cost, parenteral administration, and possible reduced efficacy over time.14 New therapeutic agents, including oral therapies, may improve disease management for psoriasis patients.15

Psoriasis clinical trial achieves adherence rate above 90%

Medication adherence challenges in psoriasis clinical trials can significantly impact the quality and outcomes of the study. Nonadherence can lead to null findings, unduly large sample sizes, and the need for dose modification after a drug has been approved.16

To minimize this impact, the sponsor of a phase IIa study testing an oral IL-36 inhibitor to treat moderate-to-severe psoriasis deployed AiCure medication adherence technology to support participants in following the dosing protocol. AiCure trained computer vision models to ensure dosing accuracy and helped participants achieve an adherence rate greater than 90% over the course of the study. Please download the case study to learn more. AiCure medication adherence technology is used in clinical trials across therapeutic areas to capture and analyze dosing behavior using smartphone video, computer vision and machine learning. Learn more in the AiCure Patient Connect fact sheet.

Addressing medication non-adherence in psoriasis clinical trials is crucial to ensure the validity and reliability of study results. Strategies to improve adherence may include patient education, regular monitoring using mobile apps such as AiCure Patient Connect, and support from clinical site personnel. In the phase IIa psoriasis trial using AiCure, clinical sites that treated patients were observed by AiCure personnel to be more engaged in the adherence strategy than other sites. Sponsors can measure both site and patient engagement using performance dashboards. Learn more in the Dosing Performance and Insights fact sheet.

1 Psoriasis as an Immune-Mediated and Inflammatory Systemic Disease: From Pathophysiology to Novel Therapeutic Approaches - PMC
2 Global Epidemiology of Psoriasis: A Systematic Review of Incidence and Prevalence - ScienceDirect
3 Ibid
4 Content powered by Perplexity AI
5 Poster Recap: Adherence Rates and Additional Treatment Patterns With Biologics and Apremilast for Moderate-to-Severe Plaque Psoriasis
6 Ibid
7 Ibid
8 Effectiveness of Mobile Applications on Medication Adherence in Adults with Chronic Diseases: A Systematic Review and Meta-Analysis
9 Ibid
10 Ibid
11 Ibid
12 Ibid
13 A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians | Dermatology and Therapy
14 Ibid
15 Ibid
16 How the EMERGE guideline on medication adherence can improve the quality of clinical trials - PMC