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دراسة فاعلية وسلامة التغيرات المختبرية ومعلمات التنبؤ للاستجابه لعقار الادالموماب في علاج عينة من المرضى العراقيين المصايين بمرض التهاب المفاصل الرماتويدي == Efficacy, Safety of Laboratory Changes and Predictors of Response to Adalimumab in Treatment of Patients with Active Rheumatoid Arthritis
Author name:
خالد عبد الحسن غضبان
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:
19T1328 - p.pdf
Abstract:
Background : Advances in the treatment of rheumatoid arthritis in recent years have profoundly muted the destructive potential of this disease. The safety profile of methotrexate has made earlier treatment possible, and biologic therapies have opened the door to combination rather than sequential therapy, with the result that treatment recommendations now aim for disease remission Objective : To evaluate the safety and efficacy and predictors of response to Adalimumab in the treatment of rhueumatoid arthritis.Patients and methods : Open labeled single group clinical trial was conducted on patients with an established diagnosis of rheumatoid arthritis who visited the Rheumatology Clinic in Baghdad Teaching Hospital from Oct. 2014 to March 2016 (17 months period).To be included, the patient should meet the 1987 American College of Rheumatology criteria for the classification of RA and the revised 2010 ACR criteria and the patients should have DAS28 score greater than or equal to 3.3(moderate - severe disease acvtivity).111 patients with RA were identified. However, only 64 patients met the inclusion/ exclusion criteria. Patients were given adalimumab (40mg) subcutaneously every other week from the start of the study to its end. For each patient, baseline data were collected during the first visit and all the participants werefollowed for six months, during which each patient was seen at monthly intervals. Demographic and clinical data were collected including age, sex, smoking history, duration of disease, history of steroids , DMARDS or other biologic treatment.Results : The age ranged between 20 and 62 years. Females constituted 87.5% of the study sample with a 7 to 1 female to male ratio. Only 4.7% were current smokers.One third (34.4%) of study subjects gave a history of past use of biologic agents, Another third (31.3%) used DMARDS &steroids were used by 67.2% of study participants. 3/4 of study subjects were classified as highly active disease (DAS28>5.1), while The remainingsubjects were classified as moderate disease activity (DAS28 3.3 to 5.1). At the end of 6 months of treatment, only 20% remained in the highly active disease category. (60%) of study subjects has shifted to the moderate disease activity category. A small proportion of study subjects (12%) are now classified as low disease activity and another 8% are in remission. (73.3%) experienced a significant reduction in DAS28 score (1.2 units or more). Another 5% experienced a smaller magnitude of treatment response, which was classified as moderate improvement. The remaining 21.7% of the treated cohort showed no improvement in DAS28 score compared to its pretreatment level (<0.6 units of reduction). Male gender, steroids and DMARDS increase the chance of having favorable response to treatment and achieving low disease activity while only steroids use have this favorable effect on achieving remission as a target and no factor affect the outcome of having significant reduction in DAS28.Hemoglobin and WBC count showed a statistically significant decrease after the full six months of treatment. Hb reduced by a mean of 0.8 gm/dl and the WBC count experienced a mean reduction of 939 x 106/mm3. In addition, both serum AST and ALT showed a statistically significant increase by a mean of 6.5 and 4.4 U/L respectively after six months of treatment. The remaining renal function tests parameters showed no important or statistically significant change after the full six months of treatment.Conclusions : Adalimumab is effective and relatively safe and well tolerated in treatment of RA patients.Male gender, steroids And DMARDS increase the chance of having favorable response to treatment and achieving low disease activity while only steroids use have this favorable effect on achieving remission as a target and no factor affect the outcome of having significant reduction in DAS28
