Ten-Year Biologic Drug Survival in Psoriasis: Role of Genetic and Cardiometabolic Predictors

NCT07041112 | Completed

• 2 other identifiers: PSO-BIO-CSP-001ICI1400136
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective observational study aims to evaluate the long-term survival of biologic therapies in adult patients with moderate-to-severe cutaneous psoriasis, with or without psoriatic arthritis, over a period of up to 10 years. The study investigates the influence of clinical, metabolic, and genetic factors, including SNPs and metabolic syndrome components, on treatment durability. Data were obtained from a single-centre cohort treated in routine clinical practice. This analysis seeks to identify predictors of therapeutic response and to explore pharmacogenetic profiles that may inform personalized treatment strategies.

Conditions

Psoriasis; Psoriatic Arthritis (PsA); Cardiovascular Risk Factors; Metabolic Syndrome (MetS); Drug Survival; Pharmacogenetics

Keywords

Biologic Therapy; Psoriasis Cohort; Genetic Variants; SNPs; Cytokines; Drug Durability; Real-World Data; Metabolic Biomarkers; Cardiometabolic Risk; Personalized Medicine; Inflammatory Skin Disease

Outcome Measures

Primary Outcomes (1)

• Drug survival at 10 years

  Time from initiation of the biologic treatment to discontinuation for any cause (inefficacy, adverse events, remission, patient decision, etc.).

  Up to 10 years from treatment start

Secondary Outcomes (8)

• Predictors of biologic drug discontinuation in patients with psoriasis

  Up to 10 years from treatment initiation

• Association between baseline soluble immune biomarkers and biologic drug survival

  Up to 10 years from treatment initiation

• Genetic variants associated with baseline soluble immune biomarker levels

  Baseline (pre-treatment)

• Mediation of genetic effects on biologic survival by soluble immune biomarkers

  From baseline to 10 years

• Incidence of new-onset psoriatic arthritis (PsA) during follow-up

  From baseline to 10 years

Study Arms (1)

Psoriasis Cohort - Observational Follow-up

Adult patients with a confirmed diagnosis of plaque psoriasis, with or without psoriatic arthritis, who initiated biologic therapy between 2010 and 2020 at tertiary dermatology clinics in Spain. Participants were followed retrospectively for up to 10 years to assess treatment survival, safety, and disease outcomes. The study explores the influence of genetic variants (450 SNPs across 65 genes), cardiometabolic comorbidities, lifestyle factors, and circulating biomarkers (adipokines, cytokines, microparticles) on treatment durability and response. No interventions were assigned by protocol.

Drug: Biologic therapy for psoriasis

Interventions

Biologic therapy for psoriasis DRUG

Exposure to systemic biologic drugs for psoriasis, including TNF inhibitors (etanercept, adalimumab, infliximab, certolizumab), IL-12/23 inhibitors (ustekinumab), IL-17 inhibitors (secukinumab, ixekizumab, brodalumab), and IL-23 inhibitors (guselkumab, risankizumab, tildrakizumab). Treatments were prescribed as part of routine clinical care.

Also known as: Anti-TNF, Anti-IL-12/23, Anti-IL-17, Anti-IL-23

Psoriasis Cohort - Observational Follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with moderate-to-severe cutaneous psoriasis, with or without psoriatic arthritis, who initiated treatment with biologic therapies at a tertiary dermatology center between 2010 and 2020. All participants had routine clinical follow-up and available biological samples for biomarker and genetic analyses.

You may qualify if:

• Adults (≥18 years) diagnosed with moderate-to-severe cutaneous psoriasis.
• Initiation of treatment with a biologic agent between 2010 and 2020.
• Minimum follow-up of 12 months or until drug discontinuation.
• Availability of clinical and treatment data at baseline.
• Availability of at least one blood sample for biomarker/genetic analysis.
• Informed consent obtained for biobanking and genetic analyses.

You may not qualify if:

• Diagnosis of other chronic inflammatory skin diseases (e.g., atopic dermatitis, lupus).
• Concomitant participation in interventional clinical trials at baseline.
• Patients with incomplete treatment history or missing survival data.
• Systemic immunosuppressive therapy (e.g., cyclosporine, methotrexate) without biologics during the study period.

Sponsors & Collaborators

• Juan Ruano Ruiz: lead
• Hospital Universitario Reina Sofia de Cordoba: collaborator
• Universidad de Córdoba: collaborator
• Maimonides Institute for Biomedical Research of Cordoba (IMIBIC): collaborator

Study Sites (1)

Department of Dermatology, Reina Sofia University Hospital

Córdoba, Córdoba, 14004, Spain

Location

Related Publications (2)

• Ruano J, Velez A, Casas E, Rodriguez-Martin A, Salido R, Isla-Tejera B, Espejo-Alvarez J, Gomez F, Jimenez-Puya R, Moreno-Gimenez JC. Factors influencing seasonal patterns of relapse in anti-TNF psoriatic responders after temporary drug discontinuation. J Eur Acad Dermatol Venereol. 2014 Apr;28(4):516-8. doi: 10.1111/jdv.12210. Epub 2013 Jul 11. No abstract available.

  PMID: 23841941 BACKGROUND

• de Luque J, Mochon-Jimenez C, Rivera-Ruiz I, Gay-Mimbrera J, Fuentes-Duculan J, Coats I, Aguilar-Luque M, Isla-Tejera B, Nieto AV, Galan-Gutierrez M, Lopez TL, Suarez-Farinas M, Krueger JG, Ruano J. A Functional Genetic Score in the ZMIZ1/TGF-beta/STAT Pathway Predicts Early Biologic Discontinuation in Psoriasis Patients Treated with Anti-TNF and Anti-IL12/23 Agents. Adv Ther. 2025 Dec;42(12):6030-6044. doi: 10.1007/s12325-025-03350-0. Epub 2025 Oct 6.

  PMID: 41051639 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples were collected and stored for genomic DNA extraction. The retained biospecimens include EDTA-anticoagulated whole blood and plasma. DNA was used for genotyping of single nucleotide polymorphisms (SNPs) across 65 candidate genes related to psoriasis, metabolic syndrome, and cardiovascular risk. Plasma aliquots were preserved for cytokine, chemokine, and cardiometabolic biomarker profiling. All samples were coded and stored under standardized biobank conditions.

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic; Metabolic Syndrome; Dermatitis

Interventions

Biological Therapy

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, IMIBIC-HURS, Córdoba, Spain

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: January 1, 2012
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

ES (1)