Clinical trial NCT06094673: The Relationship Between Systemic Immune Inflammation Index and Disease Activity in Patients With Ankylosing Spondylitis
Official title: The Relationship Between Systemic Immune Inflammation Index and Disease Activity in Patients With Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis
complete blood count
inflammation
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 18 and 65 who have been diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria

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

Eligibility criteria: 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

Primary outcomes:
measure: The Systemic Immune Inflammation Index (SII)
timeFrame: through study completion, an average of 1 month
measure: Neutrophil-to-lymphocyte ratio (NLR)
timeFrame: through study completion, an average of 1 month
measure: Platelet to-lymphocyte ratio (PLR)
timeFrame: through study completion, an average of 1 month
measure: Mean platelet volume (MPV)
timeFrame: through study completion, an average of 1 month
measure: Red blood cell distribution width (RDW)
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: C-reactive protein
timeFrame: through study completion, an average of 1 month
measure: Erythrocyte sedimentation rate
timeFrame: through study completion, an average of 1 month
measure: The Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: through study completion, an average of 1 month
measure: The Bath Ankylosing Spondylitis Functional Index
timeFrame: through study completion, an average of 1 month
measure: The Bath Ankylosing Spondylitis Metrology Index
timeFrame: through study completion, an average of 1 month
measure: Ankylosing Spondylitis Disease Activity Score with erythrocyte sedimentation rate
timeFrame: through study completion, an average of 1 month
measure: Ankylosing Spondylitis Disease Activity Score with c-reactive protein
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Therapy and Rehabilitation Research and Training Hospital
state: Bahcelievler
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: Nur Kesiktas, MD, Prof
role: STUDY_CHAIR
References:
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.
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. doi: 10.3389/fimmu.2021.760214. eCollection 2021.
citation: 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.
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.
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 May-Jun;23(4):335-338. doi: 10.1080/1354750X.2018.1425916. Epub 2018 Jan 24.