Comparative assessment of immunogenicity of recombinant insulin Aspart from BioGenomics and its originator NovoRapid® in adult patients with type 2 diabetes mellitus.

OBJECTIVES: To assess and compare the immunogenicity of recombinant Insulin Aspart [manufactured by BioGenomics Limited (BGL-ASP)] with its originator NovoRapid® (manufactured by Novo Nordisk) in adult patients with type 2 diabetes mellitus. RESEARCH DESIGN AND METHODS: BGL-IA-CTP301 study was a randomized, open label, parallel group, multicenter phase-III clinical study to compare the efficacy and safety of recombinant Insulin Aspart 100 U/mL [manufactured by BioGenomics Limited (BGL-ASP)] with its reference medicinal product (RMP); NovoRapid® [manufactured by Novo Nordisk], in adult patients with Type 2 diabetes mellitus (T2DM). The primary objective of the study was to compare the immunogenicity of BGL-ASP and RMP; NovoRapid® in patient serum samples collected from phase-III clinical study. Immunogenicity was studied as the incidence of patients positive for anti-insulin Aspart (AIA) antibodies, developed against BGL-ASP/RMP at baseline, end of 12 week and end of 24 week of the treatment period. The changes in incidence of patients positive for AIA antibodies post-baseline were also studied to assess and compare the treatment-emergent antibody response (TEAR) between the treatment groups (BGL-ASP and RMP). Statistical evaluation was done by Fisher's exact test to compare the overall incidence of patients positive for AIA antibodies and the TEAR positives observed post-baseline in both the treated groups. An in-vitro neutralizing antibody assay (Nab assay) was also performed to study the effect of AIA antibodies in neutralizing the biological activity/metabolic function of the insulin. The neutralizing potential of AIA was studied by its effect on %glucose uptake. We also evaluated the association between AIA antibody levels and its impact on biological activity by studying the correlation between them. RESULTS: Analysis of immunogenicity data suggested that the percentage of patients positive for AIA antibodies until week 24 was similar and comparable in both the treatment groups, BGL-ASP and RMP; NovoRapid®. The changes in incidence of patients positive for AIA post-baseline in terms of TEAR positives were also similar and comparable between the treatment groups. The results of the Nab assay with confirmed positive AIA samples from BGL-ASP- and RMP-treated groups did not have any negative impact on %glucose uptake by the cells in Nab assay, confirming the absence of neutralizing antibodies in both the treatment groups. The correlation studies also showed absence of association between AIA antibody levels and percentage glucose uptake in both BGL-ASP and RMP-NovoRapid® treatment groups. CONCLUSIONS: The immunogenicity assessment based on the overall incidence of patients positive for AIA, changes in incidence of patients positive for AIA post-baseline, TEAR rates and absence of neutralizing antibodies, were found to be apparently similar and comparable in both the treatment groups (BGL-ASP and RMP). We conclude from our studies that the immunogenicity of BGL-ASP is similar and comparable to RMP and the observed immunogenicity in terms of anti-insulin Aspart antibody levels had no impact on the biological activity of insulin.

Kangaroo father care to reduce paternal stress levels: A prospective observational before-after study.

OBJECTIVE: The objective was to assess stress in fathers of preterm infants and use of "Kangaroo Father Care (KFC)" to mitigate it. STUDY DESIGN: Stress levels of 30 fathers of preterm infants admitted in the NICU were assessed using the parental stressor scale: neonatal intensive care unit (PSS: NICU) before and after three sessions of KFC. The data was analysed using Wilcoxon signed rank sum test. RESULT: There was a statistically significant reduction in stress levels after KFC (p = 0.006). Amongst all the four subscales, stress levels were found to be reduced in 'staff behaviour and communication' (p = 0.001) domain and 'baby looks and behaves' domain (p = 0.05). CONCLUSION: Fathers of preterm infants admitted in the NICU experience a lot of stress, which can adversely affect their mental health. Kangaroo care is very effective in reducing this paternal stress levels.

Measles antibody levels in 3 to 9 months old infants.

Measles HI antibody titre was estimated in 248 infants aged 3 to 9 months. A total of 129 (52.02%) infants were seropositive (HI antibody titre more than 1:8). Geometric mean titre (GMT) and percentage of seropositive infants decreased with age and was minimum i.e., 5.52 and 22.22% respectively at the age of 7 months. After the age of 7 months the GMT and percentage of seropositive infants increased indicating that optimum age-of measles immunization in the area studied is around 7 months. Percentage of seropositivity did not differ significantly in relation to sex, socio-economic status and national status of infant.

Selection of the source of mixed venous blood samples in severely traumatized patients.

The technic of balloon flotation catheterization represents a significant advance in providing an additional aid to diagnosis, clinical assessment, and management of the critically ill. The fact that such patients are admitted to an intensive care unit (ICU) invariably presumes that their management will include close and accurate monitoring of the cardiovascular and respiratory systems. In a prospective study of 51 patients, not in clinical shock, in an ICU, the authors demonstrated that superior vena cava samples are not a reliable index of mixed venous blood saturation in the critically injured patient, and that a pulmonary arterial catheter is essential for obtaining true mixed venous samples for valid estimations of intrapulmonary shunts and arteriovenous O2 content differences.