دراسة فاعلية وسلامة التغييرات المختبرية ومعلمات التنبؤ للاستجابة لعقار الاداليموماب في علاج المرضى المصابين بالتهاب الفقار المقسط النشط == Efficacy, Safety of Laboratory Changes and Predictors of Response to Adalimumab in Treatment of Patients with Active Ankylosing Spondylitis
Author name:
ليث محمود شاكر
Supervisor name:
خضير زغير معيوف البدري
General topic:
Medicine
Specific topic:
Diseases - Joints
Degree:
Higher Diploma
University:
University of Baghdad - Faculty Of Medicine
Language:
English
University location:
Baghdad
First pages:
19T1361 - p.pdf
Abstract:
Background : Ankylosing Spondylitis belongs to a family of rheumatic diseases known as spondyloarthritides that characteristically cause spinal joint inflammation and bony fusion of the spine. Ankylosing spondylitis is the prototype of the Spondyloarthritides and is typified by ankylosis of the axial skeleton.There is no cure for ankylosing spondylitis, although treatments and medications are available to reduce joints pain and stiffness with subsequent improvement in quality of life.Adalimumab is a fully human monoclonal antibody of the Immunoglobulin G1isotype that neutralizes the biological function of tumor necrosis factor - α, has been used as effective treatment in ankylosing spondylitis in the last years.Objective : To assess the efficacy and safety of laboratory changes of Adalimumab in treatment of patients with active ankylosing spondylitis, as well as to assess the predictors of response to Adalimumab in treatment of patients with active ankylosing spondylitis.Patients and methods : An open labeled single group prospective study that was conducted over 17 months period on 61 Iraqi patients with ankylosing spondylitis diagnosed according to Modified New York criteria (1984) for diagnosis of ankylosing spondylitis and ASAS classification criteria for axial SpA .All the patients included in the study were given Adalimumab vial at a dose of 40 mg by subcutaneous injection every other week. Each patient was followed at regular intervals of baseline, 3 months and 6 months for disease activity including Bath Ankylosing Spondylitis Disease Activity Index and functional assessment including Bath Ankylosing Spondylitis Functional Index and for laboratory changes in hemoglobin, white blood cell count, aspartate aminotransferase, alanine aminotransferase, blood urea and serum creatinine . In addition, the study assessed eight different patients’ characteristics : age, gender, disease duration, human leukocyte antigensubtype B27, smoking, using steroids, using disease - modifying antirheumatic drugs (methotrexate, sulfasalazine), and drug history of using of other biological drugs (Etanercept, Infliximab) as predictors of response to Adalimumab treatment.Results : Data analysis showed that Bath Ankylosing Spondylitis Disease Activity Index 50% response rate was 59% after three month of treatment and reached to 85.6% after six months of treatment, the analysis also showed that the age and a positive history of using other biologic agents as apart from ( gender, disease duration, human leukocyte antigensubtype B27, smoking status , using steroids, and disease - modifying anti rheumatic drugs ) had a statistically significant association with reduced response to treatment, for each one year increase in age, the risk of being a respondent is decreased by 4% (P=0.026), and a positive history of using biologic agents is associated with decrease in the risk of being a respondent by 2.5 times (P=0.016) , all the variables were statistically significant effect on treatment and were evaluated as a strong effect (Cohen’s d>0.8). In Bath Ankylosing Spondylitis Functional Index ≥5 group, data analysis showed that their is statistically significant reduction by a mean of 2 units after three months of treatment and reached to a mean of 2.5 units after six months of treatment, the data analysis showed that increase age and a positive human leukocyte antigen - subtype B27 had a statistically significant association with reduced response to treatment, all the variables were statistically significant effects on treatment and were evaluated as a strong effect (Cohen’s d>0.8).In Bath Ankylosing Spondylitis Functional Index ˂5 group, data analysis showed that their is statistically insignificant reduction in the score of by a mean of 0.5 units after three months, and 0.6 units after six months of treatment, all the variables were statistically insignificant effects on treatment and were evaluated as a weak to moderate effect.The treatment effect of Adalimumab was evaluated as a moderately strong reduction in white blood cell count (Cohen’s d=0.43). While treatment effect on (hemoglobin, aspartate aminotransferase, alanine aminotransferase, blood urea and serum creatinine) was evaluated as week effects (Cohen’s d<0.3).Conclusion : Adalimumab drug is effective and relatively safe in treatment of patients with active ankylosing spondylitis. Increase in age, positive history of using of other biological drugs (Etanercept, Infliximab) and positive human leukocyte antigen - subtype B27 had significant correlation with reduced response to treatment.
