Pan-immune-inflammation Value (PIN) in Behçet's Disease and Its Correlation With Disease Activity

Behçet's disease (BD) is a systemic vasculitis affecting both small and large blood vessels in the venous and arterial systems. It is a multiorgan disease with various manifestations, including mucocutaneous, articular, ocular, gastrointestinal, vascular, and neurological involvements. The aim of present study is to assess pan immune inflammation value (PIN) value in BD in comparison to healthy control ,assess the PIN value in association with demographics and clinical characteristics of Behcet patients and to assess the PIN value in association with disease activity.

Study Overview

• Status: Recruiting
• Conditions: Behcet Syndrome
• Intervention / Treatment: Diagnostic test: pan immune inflammation value

Detailed Description

Behçet's disease (BD) is a systemic vasculitis affecting both small and large blood vessels in the venous and arterial systems. It is a multiorgan disease with various manifestations, including mucocutaneous, articular, ocular, gastrointestinal, vascular, and neurological involvements. Inflammation of the vascular wall is the primary pathophysiology contributing to thrombosis in BD. Hematological and biochemical values are altered due to systemic inflammation and aberrant immune response. Neutrophils, lymphocytes, and platelets play a significant role in systemic inflammation and thrombosis. In addition to the number and volume of peripheral cells, changes in multiple cell count ratios, such as the platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-lymphocyte ratio (MLR), have become important predictors of the diagnosis, disease activity, s and severe organ damage in rheumatologic disorders. pan immune inflammation value (PIV) was first described by Fuca et al and used to evaluate the inflammation. Literature showed that PIV performed better than previous immune-inflammatory biomarkers, such as NLR in colorectal cancer patients. PIV is calculated from four blood cell counts, including neutrophils, platelets, monocytes, and lymphocytes. In some rheumatological diseases such as RA, familial Mediterranean fever, and vasculitis, PIV has been studied.

In clinical practice, hematological and inflammatory laboratory tests are easily accessible and cost-effective. It is important to determine which blood parameter will be more effective in detecting disease activity and monitoring the treatment response in BD. In our study, our aim is to investigate the association of PIN with demographics and clinical characteristics of BD patients and its correlation with disease activity.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Sara Farrag, Lecturer; Phone Number: +201097767735; Email: Sara_farrag@aun.edu.eg
• Study Contact Backup: Name: Eman Mohamed, Lecturer; Phone Number: 01063489998; Email: eman202@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Recruiting
    • Assiut University Hospitals
    • Contact: Sara Farrag, Lecturer; Phone Number: +201097767735; Email: Sara_farrag@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease attending Rheumatology, Rehabilitation and Physical Medicine Department, Assiut University Hospitals.

Description

Inclusion Criteria:

• Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .
• Accept to participate in the current study.

Exclusion Criteria:

• Individuals with other autoimmune diseases.
• Patients unwilling to participate in the study.
• Patients less than 18 years old.
• Patients with malignancy or infections.
• Pregnancy and lactation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Behçet's disease; Adult Behçet's disease patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease. and Accept to participate in the current study.	Diagnostic test: pan immune inflammation value; Using the ratio of neutrophil, monocyte, and platelet counts to lymphocyte count, NLR, MLR, and PLR were calculated. The pan immune inflammation value (PIV) was calculated by multiplying the neutrophil count by the platelet count and the monocyte count, and then dividing the result by the lymphocyte count.
control group; healthy matched controls	Diagnostic test: pan immune inflammation value; Using the ratio of neutrophil, monocyte, and platelet counts to lymphocyte count, NLR, MLR, and PLR were calculated. The pan immune inflammation value (PIV) was calculated by multiplying the neutrophil count by the platelet count and the monocyte count, and then dividing the result by the lymphocyte count.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pan immune inflammation value (PIN value) in BD in comparison to healthy control	Using the ratio of neutrophil, monocyte, and platelet counts to lymphocyte count, NLR, MLR, and PLR were calculated. The pan immune inflammation value (PIV) was calculated by multiplying the neutrophil count (109/L) by the platelet count (109/L) and the monocyte count (109/L), and then dividing the result by the lymphocyte count (109/L).	3 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Sara Farrag, Lecturer, Assiut University

Publications and helpful links

General Publications

• Yazici Y, Hatemi G, Bodaghi B, Cheon JH, Suzuki N, Ambrose N, Yazici H. Behcet syndrome. Nat Rev Dis Primers. 2021 Sep 16;7(1):67. doi: 10.1038/s41572-021-00301-1.
• Bettiol A, Prisco D, Emmi G. Behcet: the syndrome. Rheumatology (Oxford). 2020 May 1;59(Suppl 3):iii101-iii107. doi: 10.1093/rheumatology/kez626.
• Fuca G, Guarini V, Antoniotti C, Morano F, Moretto R, Corallo S, Marmorino F, Lonardi S, Rimassa L, Sartore-Bianchi A, Borelli B, Tampellini M, Bustreo S, Claravezza M, Boccaccino A, Murialdo R, Zaniboni A, Tomasello G, Loupakis F, Adamo V, Tonini G, Cortesi E, de Braud F, Cremolini C, Pietrantonio F. The Pan-Immune-Inflammation Value is a new prognostic biomarker in metastatic colorectal cancer: results from a pooled-analysis of the Valentino and TRIBE first-line trials. Br J Cancer. 2020 Aug;123(3):403-409. doi: 10.1038/s41416-020-0894-7. Epub 2020 May 19.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Genetic Diseases, Inborn; Eye Diseases; Skin Diseases; Skin Diseases, Vascular; Skin Diseases, Genetic; Uveal Diseases; Vasculitis; Panuveitis; Uveitis, Anterior; Uveitis; Hereditary Autoinflammatory Diseases; Inflammation; Behcet Syndrome
• Other Study ID Numbers: SFA122024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No