What an exciting month or so it has been for learning about advances in psoriatic disease research. In the beginning of April, the University of Pennsylvania and the National Lung Heart and Blood Institute partnered to discuss the prevention of cardiovascular disease (CVD) in individuals with psoriasis and psoriatic arthritis (PsA). Toward the end of the month, New York University (NYU) held a day-long conference on the management of cardiometabolic risk in inflammatory conditions. The American Academy of Dermatology (AAD) Virtual Meeting Experience also occurred at the end of April. Then May brought the Society of Investigative Dermatology (SID) annual conference, at which the National Psoriasis Foundation (NPF) had a virtual session and discussed the NPF COVID-19 Task Force, as well as recent research and the impact health disparities have on care and outcomes.
With all this great information being shared, we wanted to provide you with the highlights related to psoriatic disease research from these meetings.
Prevention of CVD in Patients with Psoriasis and PsA: Bridging the Evidence to Practice Gap for Statins: April 9, 2021
- David Goff, M.D., Ph.D., discussed atherosclerotic cardiovascular disease (ASCVD) prevention in psoriasis, noting that psoriasis is associated with an increased risk of ASCVD. Health Care Providers should consider treating lipid and blood pressure-associated risk at lower levels of absolute risk, i.e., 10-year ASCVD risk >5%. He shared that statins reduce lipids and ASCVD in psoriasis, but they are underused.
- George Mensah, M.D., FACC, spoke about CVD and statin use in psoriasis, sharing that psoriasis and PsA are associated with increased cardiometabolic risk and premature CV mortality, preventable by effective statin treatment. He noted that strategies to promote sustained adherence to statin use that leverage care coordination and implementation science are needed, adding that diverse and inclusive participation in research must be a priority.
- John Barbieri, M.D., MBA and Rinad Beidas, Ph.D., presented unpublished data from their work related to the Psoriasis Prevention Initiative (PPI), which is an NPF-funded grant that aims to identify an intervention that will prevent the onset of psoriatic disease, disease relapse, or relevant comorbidities. Dr. Barbieri discussed how dermatologists and rheumatologists are willing to be more involved in CV risk rescreening and management and preferred approaches for implementation strategies that include decision support and education. Patients with psoriatic disease are also interested in engaging with their specialist about their CV risk, with patients noting it would be convenient to work with their specialist. However, patients are similarly likely to engage in CV risk screening and management as when recommended by PCP. Dr. Beidas discussed patient and physician perspectives on implementation of CVD prevention strategies. She noted that both dermatologists and rheumatologists endorsed counseling for CV risk and that physicians want the CVD risk of their patients to be managed but need support, such as a “multidisplinary approach” to care. The providers included in the research survey shared that they would be willing to learn about screening for CV risk if it was a collaborative care approach where they could refer the patients to another provider. Patients also shared that would like a team-based approach.
NYU Management of Cardiometabolic Risk in Inflammatory Conditions: Improving Treatment in Psoriasis, Inflammatory Arthritis, Systemic Lupus Erythematosus, and HIV: April 23, 2021
- Michael Garshick, M.D., discussed vascular endothelial disturbances in proinflammatory conditions. Investigations at NYU have pointed toward specific mechanisms of accelerated atherosclerosis in psoriasis. Evidence has shown that endothelial damage is present in this population and platelets play a role in the endothelium damage in psoriasis. The inflammasome pathway (IL1B and IL6) is the strongest circulating proinflammatory signal in psoriasis.
- Nehal Mehta, M.D., MSCE, FAHA, discussed using psoriasis as a model to study cardiometabolic risk in inflammatory conditions. He noted that human experimental models demonstrate that inflammation precedes cardiometabolic disease, and psoriasis provides a model to test the effect of chronic in vivo inflammation. In addition, the translational model provides the foundation to understand pathways, test novel therapeutics and exposures on vascular disease.
- Joel Gelfand, M.D., MSCE, presented about identifying risk and preventing CV events in patients with psoriasis and PsA. He discussed that CV risk factors are under-screened and under-managed in psoriasis patients. Statins may prevent CVD in psoriasis, and may improve psoriasis activity but are underutilized, especially in severe disease. Statins have a similar effect on lipid reduction and primary prevention of CV events in patients with psoriasis. Patients with psoriasis and their specialists are motivated to prevent CVD in this at-risk population and a care coordination model holds promise to increase the lifespan and overall health of these individuals.
- Jeffrey Berger, M.D., presented information about the role platelets have in proinflammatory conditions. Platelets are versatile effector cells in inflammation and immunity and activated platelets have key roles in thromboinflammatory activities. Additionally, platelets represent a novel modifiable target in inflammatory diseases
- Jose Scher, M.D., discussed the microbiome in rheumatic disease and cardiometabolic conditions. He noted that intestinal microbiota are mechanistically linked to physiological processes that affect both musculoskeletal and CV health. Dietary nutrients, particularly fiber, serve as key environmental influences to intestinal microbiota and human host metabolism. Modulating intestinal microbiota composition and its metabolites, including short chain fatty acids and trimethylamine-N-oxide, may serve as targets for rheumatic and CVD treatment/prevention. Exploiting the microbiome for effective initiation of antirheumatic disease treatment is a potential precision medicine strategy.
- Dr. Garshick and Dr. Mehta discussed the approach to CV risk stratification in inflammatory conditions. Screening for adverse lifestyle and cardiometabolic comorbidities was suggested. CV risk score, disease activity (greater disease involvement, needs for systemic therapy) identifies higher CV risk and could be used as part of a diagnostic process. Finally, they discussed statins and how they reduce apoB lipoproteins and T-cell activation which could be beneficial for CVD risk management.
AAD Virtual Meeting Experience: April 23-25, 2021
- Results of the Phase 3b trial, BE RADIANT, which compared bimekizumab to secukinumab, were presented at the AAD Virtual Meeting Experience and published in The New England Journal of Medicine. Findings from this study demonstrated that in individuals with moderate-to-severe psoriasis, treatment with bimekizumab, an interleukin (IL)-17A and IL-17F blocker, resulted in greater skin clearance than treatment with secukinumab over 16 and 48 weeks. However, there was an increased risk of oral candidiasis (mild or moderate) in patients treated with bimekizumab.
- Results from Phase 3 studies, POETYK PSO-1 and POETYK PSO-2, which compared deucravacitinib to both placebo and apremilast, were presented. Data showed that 58.7% of individuals taking deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, achieved a PASI 75 response at 16 weeks, compared to 25.1% and 12.7% of apremilast and placebo, respectively. This trend continued through the full 52-week study. Comparing Physician’s Global Assessment (sPGA) responses, 53.6% individuals treated with deucravacitinib in PSO-1 trial achieved a 0/1 response at 16 weeks, compared to 39.1% and 7.2% of apremilast and placebo, respectively. Similar outcomes were observed in the POETRY PSO-2 trial. In both studies, deucravacitinib had a consistent safety profile and was well-tolerated.
- Results from the Phase 3 ADVANCE trial were presented. In this trial, oral apremilast achieved a statistically significant improvement of the primary endpoint, which was static sPGA response at week 16 compared to placebo (21.6% vs 4.1%, p<0.0001). These clinical improvements were maintained through week 32. Furthermore, improvements in all secondary endpoints (improvement in BSA) and improvement in disease severity were seen.
- Tapinarof cream met the secondary endpoints in the PSOARING 1 and PSOARING 2 clinical trials, according to a poster presented. In both patient cohorts, a statistically signification number of patients experienced PASI scores of 75 or 90. PASI 75 was reported in 36.1% and 47.6% and a PASI of 90 was recorded in 18.8% and 20.9% of individuals in the tapinarof groups, PSOARING 1 and PSOARING 2, respectively.
- Guselkumab sustained skin clearance rates in majority of adults with moderate-to-severe psoriasis through 5 years, according to data presented from the VOYAGE 2 clinical trial. Additionally, improved disease activity and axial symptoms in patients with active PsA were observed through 1 year in the DISCOVER-1 and -2 trials.
- Roflumilast foam (ARQ-154, Arcutis Biotherapeutics) demonstrated safety and efficacy in improving scalp and body psoriasis. Data from the Phase 2b study showed that the primary endpoint (Scalp Investigator’s Global Assessment success defined as a score of clear/almost clear and ≥2-grade reduction from Baseline at Week 8).
SID virtual session: May 5, 2021
- Stacie Bell, Ph.D., NPF Chief Scientific and Medical Officer, spoke about NPF in general as well as the NPF COVID-19 response. This response includes discussion of the COVID-19 Task Force recommendations and ongoing guidance, patient and provider surveys, as well as webinars, podcasts, and materials for the community.
- George Gondo, MA, NPF Associate Director of Patient-Centered Research, discussed the patient-centered research happening at the NPF. Key initiatives include Citizen PScientist, Psoriatic Disease Research Ambassadors, Community Surveys and Stakeholder Engagement. The Citizen PScientist validation study of patient reported psoriasis diagnosis will be published in the Journal of Investigative Dermatology. There are a number of platform enhancements planned to elevate this patient registry as a premier tool and resource in the psoriatic disease community.
- Dr. Barbieri spoke about the prevention of CVD in patients with psoriasis and PsA. He discussed data related to the PPI that showed dermatologists and rheumatologists are willing to be more involved in CV risk screening and management, as well as that patients with psoriatic disease are interested in engaging with their specialists about CV risk. These findings support the potential of a coordinated care model.
- Charlotte Reed, MBBS, B.Sc., an NPF Fellow working with April Armstrong, M.D., MPH, NPF Medical Board Chair, discussed the impact of tailored delivery of education on engagement and disease severity. Data show that tailored delivery of education led to greater engagement compared to non-tailed delivery of education. This delivery had no impact on disease severity, compared to non-tailored delivery, but this may require a greater longitudinal assessment.
- Junko Takeshita, M.D., Ph.D., MSCE, presented on health disparities. She explained what health disparities are and that they exist for nearly every health condition, highlighting racial/ethnic disparities in mortality rates in COVID-19. While much is still unknown about health in diverse populations and health care disparities related to psoriatic disease, it is known that the social determinants to health are major causes of these health disparities.