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.

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Background: Routinely changing central venous catheters (CVCs) as a prevention strategy of bbloodstreaminfections in burns patients has been controversial due to the paucity of evidence for appropriate timings of line changes. This study aims to ascertain the risk factors associated with central line-associated sepsis and thrombosis and to evaluate the role of heparin lock, routine line changes, and thromboprophylaxis in reducing the risk of complications associated with central venous catheterization. Materials and Methods: A retrospective observational hospital-based study on 50 patients admitted with major burns (involving 40% or more total body surface area [TBSA] in burn intensive care unit/ward at Gandhi Medical College and Associated Hamidia Hospital from May 2021 to June 2022. Nontunneled, triple-lumen central lines were inserted usingthe Seldinger technique preferentially on healthy skin and secured with Tegaderm™ CHG Chlorhexidine Gluconate transparent dressing. The removal of central lines was done sepsis (persistent rise of fever unresponsive to antipyretics or empirical antibiotics) or when distal limb swelling edema) developed. Routine removal of the central line was also done when resuscitation was over and parenteral nutritional supplementation was no longer needed (after 12–15 days) or before shifting from HDU or on discharge. Data collection included: Demographics, co-morbidities, type and cause of burn, %TBSA, route (subclavian, femoral, and jugular line), access (healthy/burned) of line, duration of line in situ, complications (cellulitis, edema, venous thrombosis, and persistent high-grade fever), culture/sensitivity (c/s) reports, duration of hospital stay, heparin prophylaxis, or treatment. The data were processed with Chi-square test. The primary outcome of this observational study was a measure of catheter-related bloodstream infections and symptomatic deep vein thrombosis and their correlation with demographics and various comorbidities. Result: Central line duration and age were identified as independent risk factors for central line-associated bloodstream infection (CLABSI), with central line duration the most significant predictor (P < 0.05). CLABSI occurred at 12.81 ± 2.967 days' postline insertion. Further research is needed to assess the role of routine line changes (every 12–15 days' postinsertion) in preventing CLABSI and heparin lock in reducing the incidence of venous thrombosis. Hospital stay was prolonged in the patients developing CVC-associated complications independently increasing morbidity in patients with severe burns, but was not found to be significant (P < 0.05). Conclusion: Jugular venous route should be preferred as the site of CVC insertion (easier and associated with a lower complication rate) and the duration of line kept in situ should be reduced. The blood c/s (preferably central line tip c/s) should be sent routinely after 10 days or on the first suspicion of complications to reduce the incidence and severity of CLABSI in major burn patients.