Abstract
Introduction: This study aimed to evaluate the clinical response and safety in patients of Ankylosing spondylitis (AS) from a Rheumatology clinic in Madhya Pradesh, city Indore, after three months of Adalimumab therapy. All the patients who fulfilled modified New York criteria for AS were enrolled in the study.
Material and Methods: A total of 82 patients completed the study. The study was done initiating Adalimumab therapy due to lack of efficacy for NSAIDs and/or DMARDs were recruited consecutively from 31st December 2016 till 31st July 2017 in a Rheumatology clinic. The patients were evaluated for disease activity using the BASDAI which assesses fatigue, spinal pain, joint pain, joint swelling, areas of localized tenderness, and morning stiffness, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). Functional limitation was evaluated using Bath AS Functional Activity Index (BASFI), which assesses activities related to functional anatomy, and the patient's ability to cope with everyday life .Spinal movement was evaluated using Bath AS Metrology Index (BASMI), which measures cervical rotation, tragus to wall distance, lumbar side flexion, modified Schober's, and intermalleolar distance.
Result: The rate of improvement of Bath AS Disease Activity Index (BASDAI) (p< 0.0001), and Bath AS Metrology Index (BASMI) (p=0.0009) and BASFI (Bath Ankylosing spondylitis functional Index) were achieved (p value<0.001) after three months. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were significantly decreased (p< 0.0001, p<0.0001 respectively).No adverse effects were seen including tuberculosis in any of the patient. Significant improvement in Erythrocyte Sedimentaion Rate (ESR), C-Reactive Protein (CRP) was also seen after 3 months (P-value <0.001, P-value<0.001) Patients who showed inadequate response to conventional therapy for AS showed significant improvement with Adalimumab treatment in disease activity as well as inflammatory markers.
Conclusion: Patients who showed inadequate response to conventional therapy for AS showed significant improvement with Adalimumab treatment in disease activity as well as inflammatory markers.
Keywords: Ankylosing, Spondylitis, Adalimumab, Clinical Effectiveness; Safety.
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Corresponding Author
Dr Akshat Pandey
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DOI: https://dx.doi.org/10.18535/jmscr/v5i9.91
