Efficacy and safety of biosimilar romiplostim in Indian patients with chronic immune thrombocytopenia: A multicentric retrospective study

Context and Aims: To evaluate the efficacy and safety of biosimilar romiplostim in Indian patients with immune thrombocytopenic purpura (ITP). Settings and Design: Multicentre, retrospective observational study. Methods and Material: Patients with chronic ITP who received biosimilar romiplostim from July 2019 to March 2020 across 3 major hospitals in Guwahati, India, were included. The study outcomes were the platelet response (platelet count > 50 × 109/L), time to first response, number of dose-limiting events, and the median effective dose. Statistical Analysis Used: Descriptive. Results: Of 32 patients included in this analysis, majority (59.4%) were females. The mean (SD) age was 40.37 (15.79) years, and mean age at ITP diagnosis was 38.53 years. The median number of romiplostim doses were 27.5 (range: 10-42) over a period of 10 months; median romiplostim dose used was 4.2 ?g/kg (range: 2.8-5 ?g/kg). Platelet response was achieved as early as after one week in 9 (28.12%) patients, which continued to increase to 24 (75%) patients after the second, 30 (93.75%) patients after the third and all 32 (100%) patients after four weeks of romiplostim administration. The median platelet count was 161 × 109/L. Dose reduction was done in a total of 21 patients. Thrombocytosis (46.88%), elevated liver enzymes (15.63%) and myalgia (15.63%) were the most common adverse events. Conclusions: Biosimilar romiplostim was effective in achieving and maintaining platelet response without any new safety concerns in Indian adult patients with chronic ITP. The median effective dose of romiplostim required in our patients was lower as compared with the standard prescribed dose.

Japanese encephalitis in Assam, northeast India.

Japanese encephalitis is one of the major public health problems in Assam, northeast India. We aimed to elucidated the clinical and epidemiological profile of the disease during several outbreaks in Assam in 3 consecutive years. Cerebro-spinal fluid and or serum samples of 348 out of 773 clinically-suspected viral encephalitis patients admitted to different hospitals during the period June to August of 2000 to 2002 were tested for detection of JE specific IgM antibody, employing MAC ELISA test at RMRC (ICMR), Dibrugarh. Diagnosis was confirmed in 53.7% patients with the ratios of 1.8:1 and 1.4:1 for male to female and pediatric to adult patients respectively. Most of the cases were pediatrics at the age of 7 to 12 years (34.2%). Fever (100%), altered sensorium (81.8%), headache (70.6%), neck rigidity (54.0%), abnormal movement (51.3%), exaggerated reflexes (48.1%), restlessness (44.9%), increased muscle tone (35.3%), convulsion (33.7%) and coma (20.9%) were the major clinical findings. The majority of cases (96.3%) were from rural areas. House surroundings close to water bodies, rice cultivation, association with pigs, and climatic conditions were environmental factors affecting the abundance of the potential mosquito vectors of the disease.

HCV activity in an isolated community in north east India.

Prevalence of anti-HCV among the people at risk and general population were reported across the globe. We investigated HCV activity among the members of "Lisu" community settled in a remote and isolated area of Changlang District, Arunachal Pradesh during 1999-2000. The families were scattered with 380 households. Blood samples were collected from 76 (35 males and 45 females) apparently healthy individuals from randomly selected 10% families. Sera were processed for detection for antibody to HCV by using 3rd generation ELISA kit. All the persons were within the age of 18-98 years and 75% of them were uneducated and 92% were cultivators. The prevalence of anti-HCV was found to be very high (7.89%). Since the HCV activity is high in an isolated community, transmission dynamics study will be interesting for this epidemiologically important viral disease.

Antimicrobial susceptibility pattern among methicillin resistant staphylococcus isolates in Assam.

Prevalence of methicillin resistant Staphylococcus aureus from a referral hospital in Assam was studied. Methicillin resistance among the Staphylococcus aureus isolates was 52.9% and 15% among the coagulase negative staphylococci. Resistance to all antibiotics tested among the methicillin resistant and methicillin sensitive staphylococci was found to be 23.2% and 6.6% respectively. Higher resistance to multiple antibiotics in methicillin resistant strains as compared to methicillin sensitive strains was found to be statistically significant. Ciprofloxacin resistance among the strains was still lower in comparison to the findings from other parts of the country.

Bronchopulmonary candidiasis in a tertiary referral hospital of Assam, India.

One hundred patients with chronic chest infection suffering for more than three months admitted into a tertiary referral Hospital, northeast India were examined for pulmonary mycoses. The morning sputum samples in 3 consecutive days with a throat swab of each patient were examined for detection, isolation and identification of the fungus. Study showed Pulmonary candidiasis in 50% of the patients where Candida albicans were having highest incidence of association followed by 5 other species of Candida. Pre-existing conditions like pulmonary tuberculosis, bronchogenic carcinoma, lung abscess, bronchial asthma make the lungs prone to be invaded by the candida species. Long term antibiotics and steroids therapy was found to be associated with pulmonary candidiasis. Other conditions like irradiation treatment, malignancy, diabetes mellitus and malnutrition were also found to be the predisposing factors which influence bronchopulmonary candidiasis.