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3 results on '"Neelima Godse"'

1. A prospective, randomized, parallel group, double blind, multicenter study to compare the efficacy, safety and immunogenicity of Lupin's Ranibizumab with Lucentis® in patients with neovascular age-related macular degeneration

Author

Ramandeep Singh, Rohan Chauhan, Ashish Saxena, Anup Shah, Laxshmi Mondal, Dhananjay Bakhle, Chirag Shah, Arpit Shah, Shashank Deoghare, Neelakant Krishnan, and Neelima Godse

Subjects
biosimilar, immunogenicity, lucentis®, neovascular age-related macular degeneration (n-amd), ranibizumab, Ophthalmology, RE1-994
Abstract

Purpose: The present study compares the efficacy, safety, and immunogenicity of Lupin's biosimilar ranibizumab with that of Lucentis® in patients with neovascular age-related macular degeneration. Methods: This prospective, double-blind, multi-centric phase-III study was conducted across 19 centers in India. A total of 202 patients with neovascular age-related macular degeneration were randomized (1:1) to receive either Lupin's biosimilar ranibizumab or Lucentis®, 0.5 mg, as an intravitreous injection once every month for 3 months. The primary efficacy endpoint was the proportion of patients who lost fewer than 15 letters from baseline in best-corrected visual acuity. The safety profile included assessment of adverse events, ophthalmic examination, physical and systemic examination, and vital parameters. The immunogenicity assessment was based on evaluation of anti-drug antibodies. Results: Overall, 174 patients (87 [86.14%] in each group) completed the study. The demographics and baseline characteristics were comparable between the treatment groups. The proportion of patients losing fewer than 15 letters from baseline best corrected visual acuity score in the study eye was comparable between two groups. The difference between Lupin's ranibizumab and Lucentis® for the proportion of patients who lost fewer than 15 letters was within the predefined equivalence margin (intention-to-treat population: 1.0%; 95% confidence interval [CI], −3.3% to 5.4% and per protocol population: 1.2%; 95% CI, −3.2% to 6.4%). The incidence of treatment-emergent adverse events was comparable, and 11 (10.89%) patients in Lupin's ranibizumab and 19 (18.81%) patients in Lucentis® group had at least one treatment-emergent adverse event. The immunogenicity incidence as assessed by proportion of patients with positive anti-drug antibodies was numerically lower in Lupin's ranibizumab (4.95%) than Lucentis® (12.87%). Conclusion: Lupin's biosimilar ranibizumab demonstrated therapeutic equivalence, desirable safety, and favorable immunogenicity profile compared to Lucentis®.

Published
2022
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2. An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects

Author

Ravi Sekhar Kasibhatta, Dhananjay Bakhle, Neelima Godse, Rana Al-Jaouni, Mustafa Shennak, Santhosh Kshirasagar, Praveen Kumar Vittala, and Ahmad Al-Ghazawi

Subjects
Adult, Male, medicine.medical_specialty, Injections, Subcutaneous, Cmax, Biological Availability, Bioequivalence, 030226 pharmacology & pharmacy, Gastroenterology, Etanercept, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Pharmacokinetics, Internal medicine, medicine, Humans, Pharmacology (medical), Original Research Article, Adverse effect, Biosimilar Pharmaceuticals, Pharmacology, Cross-Over Studies, Jordan, business.industry, Middle Aged, medicine.disease, Healthy Volunteers, Confidence interval, Bioavailability, Therapeutic Equivalency, 030220 oncology & carcinogenesis, Rheumatoid arthritis, Tumor Necrosis Factor Inhibitors, Drug Monitoring, business, medicine.drug
Abstract

Background and Objectives YLB113 is being developed as a biosimilar of the antitumor necrosis factor-alpha antagonist etanercept, which is approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) and other chronic immune-mediated inflammatory diseases. An open-label, crossover, pharmacokinetic study was conducted to compare the relative bioavailability and safety of YLB113 and the etanercept reference product (RP) Enbrel®. Methods Healthy male subjects aged 18–50 years were randomized to receive a single subcutaneous dose of YLB113 in one period and the etanercept RP in another period. A washout period of 28 days separated the two treatment periods. Blood samples were collected for pharmacokinetic analysis predose and until 480 h postdose during both periods. Results Overall, 52 subjects were enrolled, including 51 subjects who completed the first period and 43 subjects who completed the second period. The 90% confidence intervals for the least squares means derived from an analysis of the log-transformed pharmacokinetic parameters maximum serum concentration (Cmax), area under the serum concentration–time curve (AUC) from 0 to the last measurable concentration (AUC(0-t)) and AUC from 0 to infinity (AUC(0-∞)) for etanercept were between the limits of 80 and 125%. Thus, YLB113 met the bioequivalence criterion. YLB113 and the etanercept RP were well tolerated, with 24 subjects reporting 53 adverse events, including 42 mild and 11 moderate events. Treatment-emergent adverse events were reported by 14 and 16 subjects following the administration of YLB113 and the etanercept RP, respectively. Conclusions A single dose of YLB113 exhibited pharmacokinetic and safety profiles comparable with those of the etanercept RP in healthy adult male subjects. Therefore, YLB113 and the etanercept RP can be considered bioequivalent. These findings support the continued development of YLB113 for use in patients with RA. Jordan Food & Drug Administration unique trial number 31/Clinical/2018. Electronic supplementary material The online version of this article (10.1007/s13318-020-00613-9) contains supplementary material, which is available to authorized users.

Published
2020
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