Rituximab biosimilar for the treatment of diffuse large B-cell lymphoma: a phase 3 randomized study in India.

PURPOSE: Very few studies have demonstrated the rituximab biosimilarity in terms of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity in patients with diffuse large B-cell lymphoma (DLBCL) in India. Therefore, we compared the efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity of our biosimilar rituximab with the reference rituximab (Ristova, Roche products [India] Pvt. Ltd) in patients with DLBCL in India. METHODS: A phase 3, randomized, assessor-blind, parallel-group, two-arm study was conducted across 28 sites in India. A total of 153 newly diagnosed DLBCL patients were randomized to receive either biosimilar rituximab or reference rituximab. The study drugs were administered at a dose of 375 mg/m2 by intravenous infusion every 3 weeks for six cycles. The primary end point was objective response rate (ORR) at the end of Cycle 6. Secondary end points included: pharmacokinetic, pharmacodynamics, immunogenicity, and safety assessment. RESULTS: The ORR at the end of Cycle 6 was 82.14% in the biosimilar rituximab and 85.71% in the reference rituximab group. The risk difference (90% CIs) was - 3.57 (- 14.80, 7.66). It met the non-inferiority margin of - 20%. The pharmacokinetic and pharmacodynamic parameters were comparable between the two treatment groups. The incidence rate of immunogenicity was very low and similar in both the treatment groups. The safety profile of both the treatments was comparable with no major difference in terms of nature, frequency and severity of TEAEs. CONCLUSION: The study demonstrated the biosimilarity between the biosimilar rituximab and the reference rituximab. Our biosimilar rituximab could add to the cost-effective treatment alternatives for patients with DLBCL in India.

A Study Oxidative Stress and its Correlation with Lipid Profile in Chronic Renal Failure Patients

Background:Chronic Renal Failure (CRF) is characterized by gradual, progressive and permanent decrease in the renal functions. Moreover, CRF adversely effects the functioning of the various other organs. Dyslipidemia is the characteristic of the CRF, moreover lipid profile disorder appear from the onset of the CRF. However, severity of disturbance depends on the stage of CRF. MDA one of the important marker of oxidative stress is the product of lipid peroxidation, which is produced by oxidation of poly unsaturated fatty acid. Increased oxidative stress leads to distruction of bio-molecules, protein, DNA and RNA of the cells. Methods: This was a cross sectional type of study conducted in the TMMC & RC, Moradabad (U.P.). Total sixty patients of CRF patients > 20 years were included in the study. Lipid profile which included serum concentration of total cholesterol (TC), triglycerides (TG) and high density lipoprotein (HDL) were calculated enzymatic method CHOD-POD method, GPO-PAP method, CHOD-POD/ Phosphotungstate method respectively Results:There was a significant difference between the mean values of TC (< 0.001), TG (< 0.001), LDL (< 0.001), VLDL (< 0.001) of CRF patients and Control group III. MDA level was significantly high in group I and group II compare to group III. Further, the levels of MDA were significantly high in group I CRF patients on dialysis when compared to group II conservatively managed patients (p < 0.001). Conclusion: Findings of the present study showed that there is increased oxidative stress level as well elevated risk of CVD in CRF patients on dialysis. More of altered level of lipids induces atherosclerosis in CRF patients. Therefore, the present study suggest that management lipids and oxidative stress should be included during the treatment of CRF patients.