Laith Mahmood Shakir, Khalid A Ghadban and Ali Mohammed Ali Al- Hamadani
Background: Ankylosing Spondylitis is a spondyloarthritide that causes spinal joint inflammation and bone fusion. Ankylosing Spondylitis produces axial skeleton ankylosis and is the prototype of Spondyloarthritides. Ankylosing Spondylitis has no cure, however therapies and drugs can lessen pain, stiffness, and quality of life. Adalimumab, a human monoclonal IgG1 antibody used to neutralise TNF-α, has shown beneficial in treating Ankylosing Spondylitis in recent years.
Objective: To evaluate the efficacy and safety of Adalimumab in patients with active Ankylosing Spondylitis (AS) and to identify predictors of response to treatment.
Methods: A single-group prospective study over 17 months involving 61 Iraqi patients with AS diagnosed by the Modified New York criteria (1984). Patients received Adalimumab 40 mg subcutaneously every two weeks. Disease activity was assessed using BASDAI, and function using BASFI at baseline, 3 months, and 6 months. Predictors of response, including age, gender, disease duration, HLA-B27, smoking, steroid use, DMARDs, and prior biologics use, were analyzed.
Results: BASDAI 50% response rate was 59% at 3 months, increasing to 85.6% at 6 months. Age (p=0.026) and prior biologics use (p=0.016) were significant predictors of response, with older age and prior biologics use associated with reduced response. BASFI ≥5 group showed a significant reduction in scores by 2 units at 3 months and 2.5 units at 6 months. In the BASFI <5 group, reductions were insignificant. WBC count reduction was moderately strong (Cohen’s d=0.43), while effects on Hb, AST, ALT, blood urea, and serum creatinine were weak.
Conclusion: Adalimumab is effective and safe in treating active AS. Age and prior biologics use significantly correlate with reduced treatment response.
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