Study Overview
This a prospective observational registry of patients with psoriasis (PsO). Longitudinal data will be collected via questionnaires from patients at a baseline visit and then approximately every 3 to 6 months for follow-up. The patient registry will focus on tracking patient outcome measures related to psoriasis.
The primary objective of this study is to identify risk factors for the development of cardiovascular disease, diabetes, and PsA among patients with psoriasis
Psoriasis is a chronic inflammatory skin condition that affects 2-3% of US adults. Psoriasis has a number of different phenotypes (i.e., plaque, guttate, erythrodermic, inverse, and pustular).(1) Plaque psoriasis is the most common. While approximately half of patients with psoriasis have mild disease (less than 3% of their body surface area, BSA), almost half of patients have moderate (3-10% of their BSA) or severe (>10% BSA).(2, 3)
Psoriasis has a significant impact on patients’ lives, even when mild. It can be itchy or painful and in severe cases can crack and bleed. Many patients have had the experience of others being afraid of them or treating them as ‘diseased’ because of the skin lesions, thinking that it may be infectious. Moreover, it has a significant impact on emotional wellbeing – social isolation (due to embarrassment or not feeling well), depression and anxiety are very common.(2, 4-7) In this study, we will examine the ways in which psoriasis impacts patients and how they manage the impact of the disease on their lives.
There are now many treatments for psoriasis that can dramatically improve not only the skin but also these psychosocial outcomes. Unfortunately, however, many patients are under treated, even those with severe disease. Even when treated, many patients are not satisfied with their current treatment and certain treatments may have more treatment burden than others.(2, 8-10) In this study, we will examine treatment of psoriasis in the United States as well as patients’ experience with treatment burden and their overall treatment satisfaction. We will also utilize the available data to compare among available treatments.
Beyond the skin findings, psoriasis is associated with systemic inflammation and as a result of this inflammation, early atherosclerosis, major adverse cardiovascular events (MACE) such as myocardial infarction, stroke and cardiovascular death, as well as increased mortality rates compared to the general population.(1) Psoriasis is additionally associated with a number of other comorbidities including an increased risk for diabetes. Little is known about which patients with psoriasis will develop these comorbidities or have a higher risk for poor outcomes.(5) In this study, we will examine risk factors for development of these common comorbidities.
Among the most common comorbidities associated with psoriasis is psoriatic arthritis (PsA), affecting 20-30% of patients over the course of their lifetime.(11) PsA is a heterogeneous inflammatory musculoskeletal disease that can cause permanent joint damage and disability. Little is known about how to predict which patients with psoriasis will develop PsA.(12-15) In this study, we will examine risk factors for development of psoriatic arthritis.
Study Measures
| Baseline | Monthly | Q6 months | |
|---|---|---|---|
| Demographics, medical history and general health | X | X | |
| Comorbid conditions | X | X | X |
| Patient Report of Extent of Psoriasis Involvement (PREPI) | X | X | X |
| Psoriasis Epidemiology Screening Tool (PEST) | X | X | |
| DLQI, PSSD, BSA, Itch VAS | X | X | |
| Global Assessment of Nail Disease | X | X | |
| Treatment satisfaction item | X | X | |
| Whole-Body (WB)-Itch Numeric Rating Scale (NRS) | X | X | X |
| Self-assessed PASI (SAPASI) | X | X | |
| Patient satisfaction with health | X | X | X |
| Skin pain NRS | X | X | X |
| Adverse events, side-effects, major events including flares | X | X | X |
| Medications (and/or medication changes) | X | X | X |
| PROMIS Global 10 | X | X | |
| Hot topic* | X | ||
| Optional: Images of target lesion, fingernails | X | ||
| Optional: Lab values (CRP) | X | ||
| *Hot topics include general questions about management or self-care that are of importance or relevance to the patient and/or scientific board. A new question will be posted each month and results fed back to the patient immediately upon answering. | |||
Resources & Research Library
Get answers to commonly asked questions about the study in our FAQ.
Researchers and Health Care Providers, download our poster to display in your office / clinic to help with recruitment.
Researchers and Health Care Providers, download our post card to display in your office / clinic to help with recruitment.
References
- Takeshita J, Grewal S, Langan SM, Mehta NN, Ogdie A, Van Voorhees AS, et al. Psoriasis and comorbid diseases: Epidemiology. J Am Acad Dermatol. 2017;76(3):377-90.
- Armstrong AW, Siegel MP, Bagel J, Boh EE, Buell M, Cooper KD, et al. From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis. J Am Acad Dermatol. 2017;76(2):290-8.
- Armstrong AW, Villanueva Quintero DG, Echeverría CM, Gu Y, Karunaratne M, Reyes Servín O. Body Region Involvement and Quality of Life in Psoriasis: Analysis of a Randomized Controlled Trial of Adalimumab. Am J Clin Dermatol. 2016;17(6):691-9.
- Armstrong AW, Foster SA, Comer BS, Lin CY, Malatestinic W, Burge R, et al. Real-world health outcomes in adults with moderate-to-severe psoriasis in the United States: a population study using electronic health records to examine patient-perceived treatment effectiveness, medication use, and healthcare resource utilization. BMC Dermatol. 2018;18(1):4.
- Elmets CA, Lim HW, Stoff B, Connor C, Cordoro KM, Lebwohl M, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. J Am Acad Dermatol. 2019;81(3):775-804.
- Gordon KB, Armstrong AW, Han C, Foley P, Song M, Wasfi Y, et al. Anxiety and depression in patients with moderate-to-severe psoriasis and comparison of change from baseline after treatment with guselkumab vs. adalimumab: results from the Phase 3 VOYAGE 2 study. J Eur Acad Dermatol Venereol. 2018;32(11):1940-9.
- Schoenberg E, Wang JV, Keller M. Impact of Psoriasis on Quality of Life: A Qualitative Study Focused on Patient Perspectives. Skinmed. 2021;19(6):438-9.
- Blauvelt A, Wu JJ, Armstrong A, Menter A, Liu C, Jacobson A. Importance of Complete Skin Clearance in Psoriasis as a Treatment Goal: Implications for Patient-Reported Outcomes. J Drugs Dermatol. 2020;19(5):487-92.
- Florek AG, Wang CJ, Armstrong AW. Treatment preferences and treatment satisfaction among psoriasis patients: a systematic review. Arch Dermatol Res. 2018;310(4):271-319.
- Salame N, Perez-Chada LM, Singh S, Callis Duffin K, Garg A, Gottlieb AB, et al. Are Your Patients Satisfied A Systematic Review of Treatment Satisfaction Measures in Psoriasis. Dermatology. 2018;234(5-6):157-65.
- FitzGerald O, Ogdie A, Chandran V, Coates LC, Kavanaugh A, Tillett W, et al. Psoriatic arthritis. Nat Rev Dis Primers. 2021;7(1):59.
- Scher JU, Ogdie A, Merola JF, Ritchlin C. Preventing psoriatic arthritis: focusing on patients with psoriasis at increased risk of transition. Nat Rev Rheumatol. 2019;15(3):153-66.
- Perez-Chada LM, Cohen JM, Gottlieb AB, Duffin KC, Garg A, Latella J, et al. Achieving international consensus on the assessment of psoriatic arthritis in psoriasis clinical trials: an International Dermatology Outcome Measures (IDEOM) initiative. Arch Dermatol Res. 2018;310(9):701-10.
- Bell S, Merola JF, Webster DE, Pennington SR, Liao W, Ogdie A, et al. Aiming for Cure and Preventive Initiatives in Psoriatic Disease: Building Synergy at NPF, GRAPPA, and PPACMAN. Curr Rheumatol Rep. 2020;22(11):78.
- Ritchlin C, Scher JU. Strategies to Improve Outcomes in Psoriatic Arthritis. Curr Rheumatol Rep. 2019;21(12):72.