A Randomised Pilot Study of the Efficacy and Safety of Using Hemoperfusion With Efferon CT to Treat Patients With Severe Psoriasis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- Efferon JSC
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in PASI (Psoriasis Area and Severity Index) score
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
Psoriasis is a chronic, inflammatory skin condition driven by the immune system, marked by red, scaly plaques that commonly affect the scalp and nails. About 30% of psoriasis patients may develop psoriatic arthritis, especially those with severe psoriasis or lesions on the nails or scalp. Research has identified distinct cytokine gene expression patterns in skin versus synovial tissue, which may explain the differing responses to biologic therapies in these areas. Factors such as genetic predisposition, infections, obesity, and biomechanical stress can trigger disease onset, leading to the release of cytokines that activate both the innate and adaptive immune responses. This immune activation can cause synovitis, enthesitis, erosions, and lesions in both articular cartilage and skin.
Given the reviewed literature and evidence that hemoperfusion with Efferon CT can non-specifically adsorb excess cytokines and inflammatory mediators, our research team hypothesizes that cytokine sorption could have beneficial clinical effects for patients with severe and moderate psoriasis. This study aims to evaluate the efficacy and safety of anticytokine hemoperfusion using the Efferon CT device for treating these patients.
Detailed Description
Psoriasis is a chronic, inflammatory, immune-mediated skin disease characterised by the appearance of erythematous and scaly plaques, often involving the scalp and nails. Approximately 30% of patients with psoriasis may develop psoriatic arthritis, particularly in patients with severe psoriasis or lesions on the nails or scalp, and a different cytokine gene expression pattern has been identified between skin and synovial tissue, explaining the differences in response to biologic therapy between these clinical areas. A predisposing genetic background, infections, obesity or biomechanical factors act as triggers and accelerate disease onset by activating macrophages, which present antigens via major histocompatibility complex type I to T cells (mainly T lymphocytes CD8) via toll-like receptor type 2. This promotes the local release of cytokines that trigger the innate and adaptive immune response. IL-12 and TNF-α stimulate a T helper cell 1 response that releases TNF-α and INF-γ. IL-23, TNF-ß, IL-6 and IL-1b activate the T helper cell 17 response in the presence of IL-23, leading to the release of IL-17 (mainly isoform A), IL-22, IL-26 and CCL20 (macrophage inflammatory protein-3α). In addition, regulation and deactivation of the inflammatory cascade requires a T-regulatory cell mediated response via IL-2 and TNF-ß. These released cytokines interact with their transmembrane receptors, promoting the release of more cytokines and the recruitment of endothelial cells, macrophages, fibroblasts, keratinocytes, dendritic cells, epithelial cells, chondrocytes, osteoclasts and osteoblasts. Activation of the immune system results in synovitis, enthesitis, erosions and lesions of articular cartilage and skin. Based on the literature data reviewed and the fact that Efferon CT hemoperfusion provides non-specific adsorption of excess cytokines and other inflammatory mediators, as demonstrated in numerous clinical studies,we hypothesised that cytokine sorption may have a positive clinical impact in severe and moderate forms of psoriasis. The aim of this study is to determine the efficacy and safety of anticytokine hemoperfusion using the Efferon CT device for the treatment of patients with severe and moderate psoriasis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ability to provide written informed consent and willingness and ability to comply with all requirements of the clinical trial design.
- •18 to 70 years of age.
- •moderate to severe psoriasis (plaque psoriasis without psoriatic arthritis) with a disease duration of at least 6 months.
- •should be receiving standard psoriasis therapy according to clinical recommendations (topical therapy, systemic therapy, phototherapy).
- •Psoriasis Area and Severity Index (PASI) score ≥10,
- •Body surface area (BSA) affected by psoriasis ≥10%,
- •Dermatology Life Quality Index (DLQI) score \>10 points,
- •physician's global assessment of psoriasis severity using the static Physician Global Assessment (sPGA) ≥3 points,
- •Dermatological Disease Severity Index (DIDS) score ≥
- •for female patients: postmenopausal or have a negative pregnancy test (urinalysis) prior to enrolment. If urinalysis does not confirm absence of pregnancy, an appropriate serum analysis should be performed. The subject's pregnancy test must be negative to be eligible for inclusion in the study.
Exclusion Criteria
- •patients with other forms of psoriasis (e.g. psoriatic erythroderma, pustular psoriasis, scale psoriasis, psoriatic arthritis) or other skin conditions (e.g. eczema).
- •patients on genetically engineered biological therapy (GEBT) for psoriasis.
- •patients with mild forms of psoriasis.
- •patients with HIV infection, syphilis, acute infectious diseases, tuberculosis.
- •patients with oncological diseases.
- •patients with chronic diseases in the stage of decompensation.
- •patients with thrombosis and recurrent thromboembolism, thrombophlebitis.
- •female patients who are pregnant or breastfeeding.
- •age of patients younger than 18 years and older than 70 years.
- •in the opinion of the investigator, inability of the subject to participate in this study for any other reason.
Outcomes
Primary Outcomes
Change in PASI (Psoriasis Area and Severity Index) score
Time Frame: 0 - 90 days
Amount of PASI value reduction, %
Change in BSA (Body surface area) score
Time Frame: 0 - 90 days
Amount of BSA value reduction, %
Change in the Dermatology Life Quality Index (DLQI) score
Time Frame: 0 - 90 days
Amount of DLQI value reduction, %
Secondary Outcomes
- Effect of hemoperfusion using Efferon CT on the severity of pruritus according to the Visual Analogue Scale (VAS)(0-90 days)
- Researchers' satisfaction with treatment efficacy and side effects of Efferon CT device in treating psoriasis patients(1-90 days)
- Safety of the Efferon CT device in patients with psoriasis(1-14 days)
- Researchers' global impression with the use of the Efferon CT device in the treatment of patients with psoriasis(1-90 days)