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

Completed

• Conditions: Ankylosing Spondylitis

• Registration Number: NCT06094673
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-02
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet to-lymphocyte ratio (PLR)	through study completion, an average of 1 month	PLR is a ratio between the absolute platelet count and absolute lymphocyte count.
The Systemic Immune Inflammation Index (SII)	through study completion, an average of 1 month	The Systemic Immune Inflammation Index (SII) was calculated by dividing the product of neutrophil and platelet counts by the lymphocyte count.
Neutrophil-to-lymphocyte ratio (NLR)	through study completion, an average of 1 month	NLR is a ratio between the absolute neutrophil count and absolute lymphocyte count.
Mean platelet volume (MPV)	through study completion, an average of 1 month	MPV blood test measures the average size of patient's platelets
Red blood cell distribution width (RDW)	through study completion, an average of 1 month	A red cell distribution width (RDW) test measures the differences in the volume and size of the red blood cells (erythrocytes).

Secondary Outcome Measures

Name	Time	Method
The Bath Ankylosing Spondylitis Metrology Index	through study completion, an average of 1 month	The index helps to evaluate spinal mobility of AS patients. Higher scores indicate more limited mobility.
The Bath Ankylosing Spondylitis Disease Activity Index	through study completion, an average of 1 month	The index indicates that disease activity of AS patients. Higher scores indicate that higher activity
The Bath Ankylosing Spondylitis Functional Index	through study completion, an average of 1 month	The index helps to evaluate disease activity of AS patients. High scores indicate that worse functional status.
Ankylosing Spondylitis Disease Activity Score with erythrocyte sedimentation rate	through study completion, an average of 1 month	it helps to evaluate disease activity of AS patients by used to esr
Ankylosing Spondylitis Disease Activity Score with c-reactive protein	through study completion, an average of 1 month	it helps to evaluate disease activity of AS patients by used to crp
C-reactive protein	through study completion, an average of 1 month	C-reactive protein (CRP) is a protein made by the liver. The level of CRP increases when there's inflammation in the body.
Erythrocyte sedimentation rate	through study completion, an average of 1 month	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

Trial Locations

Locations (1)

Istanbul Physical Therapy and Rehabilitation Research and Training Hospital; 🇹🇷 Istanbul, Bahcelievler, Turkey