The Relationship Between Systemic Immune Inflammation Index and Disease Activity in Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

The Relationship Between Systemic Immune Inflammation Index and Disease Activity in Patients With Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06094673
• Other study ID #: IstPRMTRH4
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: July 2, 2023

Study information

• Verified date: February 2024
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In this study, the aim was to investigate the relationship between SII and other laboratory parameters with disease activity in AS patients and to discuss its usability in the follow-up and treatment process.

Description:

This study aimed to investigate the relationship between the systemic immune inflammation index (SII), platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and disease activity and functional status in patients with ankylosing spondylitis (AS). A cross-sectional clinical study was conducted, and a total of 90 patients diagnosed with AS according to the Modified New York Criteria, aged between 18 and 65, who presented to our outpatient clinics were included in the study. Demographic data, disease duration, age at symptom onset, and laboratory parameters, including platelet, neutrophil, basophil, eosinophil, lymphocyte counts, mean platelet volume (MPV), red blood cell distribution width (RDW), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR), were recorded. NLR and PLR values were calculated. The Systemic Immune Inflammation Index (SII) was calculated by dividing the product of neutrophil and platelet counts by the lymphocyte count. We investigated all of these parameters and disease activity scores. Disease activity was assessed with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), spinal mobility with the Bath Ankylosing Spondylitis Metrology Index (BASMI), and functional status with the Bath Ankylosing Spondylitis Functional Index (BASFI). In addition, during the routine follow-ups of patients, requested blood tests were examined, and platelet, neutrophil, basophil, eosinophil, lymphocyte counts, mean platelet volume (MPV), RDW (red blood distribution width), CRP, and ESR values will be recorded. Neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), and systemic immune inflammation index (SII) were calculated

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients between the ages of 18 and 65 who have been diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria, have applied to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital outpatient clinic on the specified dates, meet the exclusion criteria, and have complete blood count, CRP, and ESR values in their hospital records.

Exclusion Criteria:

• Presence of acute or chronic infection

• Presence of autoimmune diseases other than Ankylosing Spondylitis

• Pregnancy

• Diabetes

• Chronic kidney disease

• Chronic liver disease

• Malignancy

• Cardiovascular disease

• Hematological disease

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Inflammation
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Turkey	Istanbul Physical Therapy and Rehabilitation Research and Training Hospital	Istanbul	Bahcelievler

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Choe JY, Lee CU, Kim SK. Association between Novel Hematological Indices and Measures of Disease Activity in Patients with Rheumatoid Arthritis. Medicina (Kaunas). 2023 Jan 6;59(1):117. doi: 10.3390/medicina59010117. — View Citation

Liang T, Chen J, Xu G, Zhang Z, Xue J, Zeng H, Jiang J, Chen T, Qin Z, Li H, Ye Z, Nie Y, Zhan X, Liu C. Platelet-to-Lymphocyte Ratio as an Independent Factor Was Associated With the Severity of Ankylosing Spondylitis. Front Immunol. 2021 Nov 5;12:760214. — View Citation

Satis S. New Inflammatory Marker Associated with Disease Activity in Rheumatoid Arthritis: The Systemic Immune-Inflammation Index. Curr Health Sci J. 2021 Oct-Dec;47(4):553-557. doi: 10.12865/CHSJ.47.04.11. Epub 2021 Dec 31. — View Citation

Seng JJB, Kwan YH, Low LL, Thumboo J, Fong WSW. Role of neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR) and mean platelet volume (MPV) in assessing disease control in Asian patients with axial spondyloarthritis. Biomarkers. 2018 M — View Citation

Wu J, Yan L, Chai K. Systemic immune-inflammation index is associated with disease activity in patients with ankylosing spondylitis. J Clin Lab Anal. 2021 Sep;35(9):e23964. doi: 10.1002/jcla.23964. Epub 2021 Aug 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Systemic Immune Inflammation Index (SII)	The Systemic Immune Inflammation Index (SII) was calculated by dividing the product of neutrophil and platelet counts by the lymphocyte count.	through study completion, an average of 1 month
Primary	Neutrophil-to-lymphocyte ratio (NLR)	NLR is a ratio between the absolute neutrophil count and absolute lymphocyte count.	through study completion, an average of 1 month
Primary	Platelet to-lymphocyte ratio (PLR)	PLR is a ratio between the absolute platelet count and absolute lymphocyte count.	through study completion, an average of 1 month
Primary	Mean platelet volume (MPV)	MPV blood test measures the average size of patient's platelets	through study completion, an average of 1 month
Primary	Red blood cell distribution width (RDW)	A red cell distribution width (RDW) test measures the differences in the volume and size of the red blood cells (erythrocytes).	through study completion, an average of 1 month
Secondary	C-reactive protein	C-reactive protein (CRP) is a protein made by the liver. The level of CRP increases when there's inflammation in the body.	through study completion, an average of 1 month
Secondary	Erythrocyte sedimentation rate	The erythrocyte sedimentation rate (sedimentation rate, sed rate, or ESR for short) is a commonly performed hematology test that may indicate and monitor an increase in inflammatory activity within the body caused by one or more conditions such as autoimmune disease, infections, or tumors	through study completion, an average of 1 month
Secondary	The Bath Ankylosing Spondylitis Disease Activity Index	The index indicates that disease activity of AS patients. Higher scores indicate that higher activity	through study completion, an average of 1 month
Secondary	The Bath Ankylosing Spondylitis Functional Index	The index helps to evaluate disease activity of AS patients. High scores indicate that worse functional status.	through study completion, an average of 1 month
Secondary	The Bath Ankylosing Spondylitis Metrology Index	The index helps to evaluate spinal mobility of AS patients. Higher scores indicate more limited mobility.	through study completion, an average of 1 month
Secondary	Ankylosing Spondylitis Disease Activity Score with erythrocyte sedimentation rate	it helps to evaluate disease activity of AS patients by used to esr	through study completion, an average of 1 month
Secondary	Ankylosing Spondylitis Disease Activity Score with c-reactive protein	it helps to evaluate disease activity of AS patients by used to crp	through study completion, an average of 1 month