A Multi-centre Study to Evaluate the Long-Term Efficacy and Safety of Biosimilar Infliximab (Infimab™) in Ankylosing Spondylitis in Real-world Clinical Settings - A perspective from Eastern India

Introduction: Owing to dearth of data on infliximab biosimilars in Indian patients, a pan-India case database-based study with infliximab biosimilar BOW015 (Infimab™) was carried out to capture its efficacy and safety in real world clinical settings in India. Here, we assessed its efficacy and safety in ankylosing spondylitis (AS) among patients in the East India cohort. Materials and methods: Data were collected from multiple centers across the eastern region of India. Patients diagnosed with AS, within the preceding 4-6 months during the preceding one year were included in the study. Patients who were given BOW015 for other indications, prior innovator infliximab or other biologics were excluded from the study. Primary variable was Ankylosing Spondylitis Disease Activity Scale (ASDAS) response defined as change of > 2 in the ASDAS score from the baseline by 4-6 months of follow up. Results: The cohort consisted of 149 patients, predominantly male (69.8%), with mean (±SD) age of 36.75 (±11.11) years and mean (±SD) body weight of 58.26 (±15.4) kgs. Of the treated patients, 91 (61.1%) patients were administered four doses, 10 (6.7%) patients were administered three doses, 37 (24.8%) patients were administered two doses and 11 (7.4%) patients were administered only a single dose of BOW015. In the final analysis set, 81 patients had data at baseline and 4th visit. Among the 81 patients, 74 (91%) patients achieved major improvement, 5 (6%) patients achieved clinically important improvement and 2 (3%) were non-responders at 4th visit. Secondarily, cross categorization of the cohort into disease activity categories by number of infusions administered from baseline to 4th visit and assessment of trends in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores were also carried out and these too confirmed the efficacy of BOW015. Conclusion: Infimab™ (BOW015) showed significant improvement in ASDAS and BASDAI in patients with AS at the end of 4-6 months of follow up with its clinical benefits being apparent as early as first dose of BOW015

Fibroset™ and neuromuscular pain: a multicentric, real world, observational, post-marketing surveillance study in Indian patients suffering from neuromuscular pain

Background: Neuromuscular disease (NMD) is a condition due to abnormality or damage to muscles and nerves causing painful symptoms. Symptomatic management involves use of conventional painkillers, but desirable relief is not achieved due to multimodal pathophysiology of disease. This study evaluated the efficacy and safety of Fibroset™ tablets in subjects with neuromuscular pain. Methods: Subjects with neuromuscular pain, previously unsatisfied with standard therapies, were enrolled. Subjects were advised to take Fibroset™ one tablet BID for 2 weeks with their standard therapy. Efficacy was evaluated on pain, stiffness, swelling, weakness, tenderness, and difficulty in activity of daily living (ADL) as per the visit schedule. Tolerability of therapy was also evaluated. Results: 59 patients were enrolled in study and 46 patients were included in the final analysis. Fibroset™ supplementation significantly reduced all evaluated parameters (p<0.05 vs baseline). The mean pain score from 2.50 to 0.89, while mean stiffness score was reduced to 0.55 from 1.87 at end of study. The mean swelling score was reduced to 0.81 from 2.04, while the mean weakness score was reduced to 0.64 from baseline score of 1.79. The mean tenderness score was reduced from baseline score of 1.90 to 0.65 and the mean ADL score was reduced to 0.63 from baseline score of 2.00. No treatment related side effects were observed. Conclusions: Fibroset™ is a potentially effective and safe therapy for subjects with neuromuscular pain. It can be used to reduce symptoms in patients with unsatisfactory results with conventionally standard care therapy