Current Burden of Atopic Dermatitis in India: A Systematic Literature Review.

Atopic dermatitis (AD) is a common chronic dermatological condition affecting ~10% of adults and ~20% of the paediatric population in high-income countries. There is a lack of comprehensive understanding of the disease burden of AD in India. In this systematic review, the primary objective was to review epidemiological data on AD in India based on articles published between 2011 and 2021. The secondary objective was to assess the disease burden from economic and quality of life (QoL) perspectives. A literature search was conducted using the PubMed and Google Scholar databases using predefined search strings. Relevant studies published in English on AD between 2011 and 2021 were included. This review included 11 articles, of which nine reported demographic and clinical characteristics. The reported prevalence ranged from 3.1% to 7.21% among the paediatric population, up to 16 years of age. The prevalence of AD ranged from 0.98% to 9.2% in studies including paediatric and adult patients. The cost of medications was reported to be the major contributor to the economic burden associated with AD. Mental illnesses such as depression and anxiety were frequently reported in association with AD. Although AD is a common disorder affecting all age groups, there is a lack of substantial epidemiological data. None of the current studies covers the entire country. Hence, studies with a wider geographic scope covering all aspects of disease burden are required to help clinicians and policymakers to understand the disease burden and devise appropriate preventive and management strategies.

Non-alcoholic Steatohepatitis in Asians: Current Perspectives and Future Directions.

Non-alcoholic steatohepatitis (NASH) is a subset of non-alcoholic fatty liver disease (NAFLD), which, apart from excess fat in the liver, may be characterised by some level of inflammatory infiltration and fibrogenesis, occasionally progressing to liver cirrhosis or hepatocellular carcinoma (HCC). The objective of the current review is to elucidate the rising prevalence, the role of microbiome and genetics in pathogenesis, diagnostic challenges, and novel treatment alternatives for NASH. Newer diagnostic techniques are being developed since using liver biopsy in a larger population is not a reasonable option and is primarily restricted to clinical research, at least in developing countries. Besides these technical challenges, another important factor leading to deviation from guideline practice is the lack of health insurance coverage in countries like India. It leads to reluctance on the part of physicians and patients to delay required tests to curb out-of-pocket expenditure. There is no cure for NASH, with liver transplantation remaining the last option for those who progress to end-stage liver disease (ESLD) or are detected with early-stage HCC. Thus, lifestyle modification remains the only viable option for many, but compliance and long-term adherence remain major challenges. In obese individuals, bariatric surgery and weight reduction have shown favourable results. In patients with less severe obesity, endoscopic bariatric metabolic therapies (EBMT) are rapidly emerging as less invasive therapies. However, access and acceptability remain poor for these weight reduction methods. Therefore, intense research is being conducted for potential newer drug classes with several agents currently in phase II or III of clinical development. Some of these have demonstrated promising results, such as a reduction in hepatic fat content, and attenuation of fibrosis with an acceptable tolerability profile in phase II studies. The developments in the management of NASH have been fairly encouraging. Further well-designed long-term prospective studies should be undertaken to generate evidence with definitive results.

Ceftazidime-avibactam plus metronidazole vs. meropenem in complicated intra-abdominal infections: Indian subset from RECLAIM.

INTRODUCTION: This study analyzes the safety and efficacy results of the Indian population subset from the RECLAIM trial investigating the non-inferiority of Ceftazidime-Avibactam (CAZ-AVI) plus metronidazole to meropenem and interprets its relevance. METHODOLOGY: The study design, subjects inclusion criteria, dosage, safety and efficacy evaluations in Indian patients have been followed as per the RECLAIM trial protocol. RESULTS: A total of 142 Indian patients with complicated intra-abdominal infection were enrolled across eight centers in India, 125 of them were randomized to either CAZ-AVI + metronidazole (n = 62) or meropenem (n = 63) group. the clinical cure rates in modified intention-to-treat (MITT; all randomized patients who met minimum disease requirements and received any amount of study drug) and clinically evaluable (CE , patients who had an evaluable assessment and no protocol deviations) analysis sets, was numerically comparable to the results of overall population for CAZ-AVI + metronidazole [MITT: 82.5% (Overall, n = 429/520) versus 89.3% (Indian, n = 50/56); CE: 91.7% (Overall, n = 376/410) versus 97.8% (Indian, n = 45/46)] and meropenem [MITT: 84.9% (Overall, n = 444/523) versus 84.7% (Indian, n = 50/59); CE: 92.5% (Overall, n = 385/416) versus 95.5% (Indian, n = 42/44)]. No new safety findings were reported in the Indian population. CONCLUSIONS: CAZ-AVI + metronidazole proved to be an effective option for critical patients with complicated intra-abdominal infection and can be considered as an alternative to carbapenems in the ICU setting for the treatment of resistant pathogens.

Clinical outcomes of ceftazidime-avibactam versus meropenem in Indian patients with nosocomial pneumonia: Subset analysis from the REPROVE study.

The efficacy and safety of Ceftazidime-Avibactam (CAZ-AVI) as compared to meropenem for nosocomial pneumonia was established in a randomized, phase-III, non-inferiority trial REPROVE, which included Indian patients. We determined if the results for the Indian patients were in-line with the results of overall population. Descriptive analysis of efficacy and safety demonstrated ceftazidime-avibactam was comparable to meropenem in the management of nosocomial pneumonia in Indian patients and it may be a useful addition to the armamentarium of antibiotics for management of such infections with Enterobacterales and Pseudomonas.

Burden of Disease, Unmet Needs in the Diagnosis and Management of Atopic Dermatitis: An Indian Expert Consensus.

BACKGROUND: Atopic dermatitis (AD) is a chronic inflammatory, non-communicable, and relapsing skin disease that affects all age groups. There is a dearth of literature that reports the disease burden, and epidemiology and highlights unmet needs in the diagnosis and management of AD in India. METHODS: A total of ten specialists including dermatologists, pediatric dermatologists, and pediatricians with more than ten years of experience and practicing in different parts of India served as the expert panel during the virtual meet conducted on January 24, 2021. A questionnaire comprising 32 questions on different aspects of AD management was categorized among different sections: burden of disease (five questions), age of onset and prevalence (five questions), etiology and pathogenesis (six questions), diagnosis and severity of the disease (seven questions), and treatment (nine questions). Consensus was defined when agreement was provided by ≥90% of the experts. RESULTS: Considering the profound impact AD has on the quality of life (QoL) of patients, the expert panel recommended patient counseling while moderate to severe cases of AD need a prompt referral to a specialist. The panel did not recommend any specific diagnostic and severity criteria as a standard due to the inherent limitations associated with every criterion. The role of environment and changing lifestyle in addition to genetic and familial risk factors for AD was also considered. The panel unanimously recommended to conduct a countrywide, multicenter survey/study to estimate the true prevalence of AD in India. Further, the experts recommended to follow proper treatment protocols and to perform longitudinal monitoring for understanding corticosteroid treatment associated side effects. CONCLUSION: This guidance focuses on identifying the unmet gaps and provides practical recommendations for improving QoL, diagnosis, prognosis, and overall management of patients with AD in India.

Tofacitinib in the treatment of Indian patients with rheumatoid arthritis: A post hoc analysis of efficacy and safety in Phase 3 and long-term extension studies over 7 years.

OBJECTIVES: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized tofacitinib efficacy/safety in Indian vs rest of the world (ROW; excluding India) RA patients. METHODS: Efficacy data were pooled for disease-modified antirheumatic drug (DMARD) inadequate responders from Phase (P)3 studies. For Indian patients, ORAL Solo and ORAL Scan; ROW (excluding India), these studies plus ORAL Step, ORAL Sync, and ORAL Standard. Safety data also included ORAL Start (P3; methotrexate-naïve) and ORAL Sequel (long-term extension [LTE] study; data cut-off March 2017) for Indian patients, and these studies plus A3921041 (LTE study; Japanese study) for ROW. Efficacy outcomes at months 3/6: American College of Rheumatology (ACR)20/50/70; Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission/low disease activity; change from baseline in Health Assessment Questionnaire-Disability Index. Incidence rates (IRs; patients with events/100 patient-years) for adverse events of special interest (AESIs) were assessed throughout. Descriptive data underwent no formal comparison. RESULTS: One-hundred-and-ninety-seven Indian and 3879 ROW patients were included. Compared with ROW patients, Indian patients were younger, had lower body mass index, shorter RA duration, and higher baseline disease activity; most Indian patients were non-smokers and all were biologic DMARD (bDMARD)-naïve. Month 3 ACR20 rates with tofacitinib 5 mg twice daily/10 mg twice daily/placebo were 67.4%/82.1%/40.9% (India) and 59.0%/66.1%/28.2% (ROW), and month 6 rates were 76.2%/92.1%/88.9% (India) and 69.0%/74.2%/66.5% (ROW). Month 3/6 improvements in other outcomes were generally numerically greater with tofacitinib vs placebo, and similar in both populations. Compared with ROW, Indian patients had numerically fewer AEs/serious AEs, and similar IRs for discontinuations due to AEs and AESIs, except that tuberculosis (TB) IR was higher in Indian (IR = 1.21; 95% CI 0.49, 2.49) vs ROW patients (IR = 0.17; 95% CI 0.11, 0.25). CONCLUSIONS: Tofacitinib efficacy/safety were similar in both populations, except TB IR, which was higher in Indian patients but in line with those in bDMARD-treated RA patients from high-risk countries (IR = 0.00-2.56; TB IR >0.05 [World Health Organization]). Limitations included the small Indian population and baseline differences between populations.