Background: The regulatory phase III trial supporting the approval of biosimilar infliximab (BOW015) in India included only rheumatoid arthritis patients. Consequently there is paucity of data on the effectiveness of BOW015 in Ankylosing Spondylitis (AS). 1,2,3 Hence, we decided to objectively quantify the effectiveness and safety of BOW015 in AS patients. Objectives: To determine safety, efficacy and tolerability of BOW015 in Indian AS patients. Methods: We retrospectively collected data from seven centres to get a comprehensive picture of the Indian population. The protocol along with data collection form was designed by the investigators and ethics committee approval was obtained. Biologic naïve patients diagnosed with AS as per Assessment of Spondylo Arthritis International Society criteria who were having six months of follow up data during January-November 2016 were included in the study. Percentage of patients achieving major clinical improvement (Ankylosing Spondylitis Disease Activity Score C-reactive protein (ASDAS C R P) >2 from the baseline to six months of follow up) was the primary variable. Secondary variables included; clinical improvement criteria (ASDAS CRP >1.1 from the baseline to six months of follow up), change in ASDAS CRP , Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), CRP and Erythrocyte Sedimentation Rate (ESR) from the baseline to six months. Variables were reported as mean ± Standard Deviation (SD), absolute change in variable were reported along with their Confidence Interval (CI) and data was analyzed using Statistical Package for the Social Science V-22. Results: A total of 68 patients treated with BOW015 having follow-up data for six months were analyzed. Mean age of patients was 32.63±11.73 (SD) years with mean body mass index of 25.72±7.48 (SD) kg/m 2 and about 32 (47%) patients had peripheral arthritis. Of the treated patients, 52 (76%) patients were administered four doses while 6 (9%) patients administered three doses, 3 (5%) patients administered two doses and 7 (10%) patients administered single dose as they were loss to follow up. As per the primary variable, 67.9% patients achieved major clinical improvement, 9.4% patients achieved clinical improvement and 22.6% were non-responders. There was an absolute change of-2.54 (95% CI-1.92,-3.17) in BASDAI and-1.77 (95% CI-1.43,-2.11) in ASDAS CRP right from first follow up corresponding to post 1st dose visit which was statistically significant (see Table-1). This trend was observed in the subsequent visits in BASDAI, ASDAS CRP , ESR and CRP which continued till the end of six months. One patient developed pulmonary tuberculosis and marginally elevated liver enzymes were seen in two patients. Conclusions: BOW015 showed significant improvement in ASDAS CRP and BASDAI in patients with AS on a six month follow up period and the clinical benefits were apparent as early as first dose of BOW015.

Introduction: Diabetes mellitus is one of the leading cause of mortality and morbidity worldwide. Type 2 DM is a complex group of disorders characterized by different levels of insulin resistance, impaired secretion of insulin , and increased production of glucose. The complications of diabetes mellitus are inuenced by the average level of blood glucose along with glycosylated hemoglobin. Serum ferritin is an indicator of iron store. Iron stores are associated with decrease in insulin sensitivity, insulin secretion and hence type 2 diabetes. Methods: This study was done in Department of Biochemistry in collaboration with Medicine Department of Gandhi medical college Bhopal. 160 previously diagnosed type 2 diabetes subjects (mean age 55.59±7.74 years) with mean BMI 30.14±3.48kg/m2 were taken and their Serum ferritin, Fasting Blood Sugar and Glycosylated Hemoglobin were measured. Results: It was found that serum ferritin was signicantly high in diabetic patients and serum ferritin had a positive correlation with increasing glycosylated hemoglobin and Fasting blood sugar. Conclusion:It was concluded that serum ferritin level can be used as an indicator of control of glycaemia in type 2 diabetes mellitus patients. HbA1C and Serum ferritin level can also be used as a marker to prevent complications of the disease.

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Objective: To determine the efficacy and safety of novel infliximab biosimilar, Infimab TM (IFB) in rheumatoid arthritis (RA) patients. Materials and Methods: Eight patients with active RA who failed to demonstrate clinical improvement with methotrexate were enrolled. Post consent, patients were administered infliximab biosimilar 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks on demand. Patients were assessed for Health assessment questionnaire (HAQ, India Score), disease activity score 28 (DAS 28), Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC), erythrocyte sedimentation rate (ESR) and Visual Analogue Scale (VAS) score at baseline and at each visit. They were also observed for any adverse effects or tuberculosis infection. Wilcoxon sign rank test was used to assess the change between baseline to each follow-up visit. Results: On any average 3 infusions were administered to patients. At visit 3 there was significant improvement in HAQ score (p=0.046), WOMAC score (p=0.018), Tender joints count (p=0.027), swollen joints count (p=0.027) and also in general health (p=0.043). Though the VAS scores and ESR values decreased at visit 3, they were not significant. At the end of visit 5, there was considerable decrease in the tested parameters, except in tender joint count. None of the patients reported any adverse effects, indicating that infliximab biosimilar was well-tolerated in tested patients. Conclusion: In this preliminary trial conducted in eight RA patients, treatment with IFB improved clinical outcomes and was well-tolerated in RA patients who failed initial treatment with methotrexate