Safety and Efficacy of Golimumab in Indian Patients with Active Spondyloarthritis of Ankylosing Spondylitis or Psoriatic Arthritis: A Multicenter, Noncomparative, Open-Label, Real-World Study.

BACKGROUND: The safety and efficacy of tumor necrosis factor-α (TNF-α) inhibitor therapy for most common rheumatological diseases, ankylosing spondylitis (AS), and psoriatic arthritis (PsA) in controlled clinical trials is well-studied. This study evaluated subcutaneous (SC) golimumab in Indian patients with active spondyloarthritis (SpA) of AS or PsA in a real-world setting. MATERIALS AND METHODS: This phase 4, multicenter, prospective, non-comparative, interventional, 24-week study was performed in patients (age ≥18 years) with active SpA of AS or PsA (NCT03733925). Golimumab 50 mg was given subcutaneously to the patients every 4 weeks. Safety was assessed. The proportion of patients with AS and PsA achieving ≥20% improvement in the Assessment of SpA International Society 20 (ASAS20) criteria and American College of Rheumatology 20 (ACR20) responses, respectively, at weeks 14 and 24 were efficacy endpoints. RESULTS: Of the 100 patients enrolled (men: 78 [78.0%]; mean age: 36.7 [12.02] years), 94 (94.0%) patients completed the study. Treatment-emergent adverse events with golimumab were observed in 29/100 (29.0%) patients, and nasopharyngitis and upper respiratory tract infection (5.0% each) were the most common (≥5%). Deaths were not reported. At week 14, 74.5% (95% confidence interval [CI]: 59.7; 86.1%) of patients with AS and 84.6% (95% CI: 69.5; 94.1%) of patients with PsA achieved ASAS20 and ACR20 responses, which were sustained at week 24 (ASAS20: 66.0% [95% CI: 50.7, 79.1%]; ACR20: 93.2% [95% CI: 81.3, 98.6%]), respectively. CONCLUSION: Golimumab (50 mg) administered subcutaneously was safe and effective in Indian patients with active SpA of AS or PsA during the 24-week study period with no new safety signals.

Seroprevalence of COVID-19 Amongst Health Care Workers in a Tertiary Care Hospital of a Metropolitan City from India.

BACKGROUND: Seroprevalence studies for COVID-19 evaluate the extent of undetected transmission in a defined community, with special significance among health care workers (HCW) owing to their greater exposure and potential to transmit. METHODS: A total of 1122 HCW (approximately 25% of the employees) of a large tertiary care hospital in India were recruited for this cross-sectional study. COVID PCR-positive HCW were excluded. Based on their risk-assessment, participants were grouped into three categories. A questionnaire was administered and they were tested for SARS-CoV-2-IgG antibodies using the chemiluminescence. RESULTS: The overall seroprevalence among workers was 11.94%, which included 19.85% in COVID units, 11.09% in non-COVID units, and 8% in administrative workers (p=0.007). Antibody prevalence was highest in the department of gastroenterology (11.94%), followed by oncology (10.53%), pathology (10.26%), emergency medicine (7.84%) and critical care medicine (7%). Housekeeping staff, food and beverage staff, lab assistants and technicians had higher seroprevalence rate than doctors and nurses (p < 0.0001). HCW with a history of BCG vaccination in childhood and those who received an adequate prophylactic dose of hydroxychloroquine (HCQ) had a lower seroprevalence as compared to those who did not (7.31% vs. 16.8% and 1.30% vs. 11.25% respectively). CONCLUSION: BCG vaccination, HCQ prophylaxis, and the job profile influence the seroprevalence rate in HCW. Seroprevalence rate and follow-up evaluation of its durability may help hospitals to triage their staff at risk, rationalize their placement, prioritize the use of PPE, thereby potentially reducing the risk.

Efficacy and safety of an anti-CD20 monoclonal antibody (Reditux™) for the treatment of patients with moderate to severe rheumatoid arthritis following the failure of conventional synthetic disease-modifying anti-rheumatic drugs.

Rituximab (anti-CD20 monoclonal antibody) has shown to improve symptoms in rheumatoid arthritis (RA) patients with inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). An anti-CD20 monoclonal antibody (Reditux™) developed by Dr. Reddy's Laboratories, India, is currently approved for use both in rheumatology and oncology patients. This retrospective report evaluates the efficacy and safety data from the real-world use of Reditux™ over a 6-month period in Indian patients with RA. All consecutive moderate to severe RA patients who failed therapy with at least two DMARDs including methotrexate (MTX) for 6 months, TNFα inhibitor naive, and willing to take Reditux™ were included. They were prescribed two doses of 1 g Reditux™, at least 15 days apart, with continued stable doses of methotrexate. Efficacy and safety after 24 weeks relative to baseline was assessed using various health assessment variables. A total of 39 patients (mean age of 46 years; 67.5 % females) treated with Reditux™ were evaluated. Statistically significant differences were observed in mean changes of DAS28-CRP, DAS28-ESR, SDAI, HAQ and Patient Global Assessment scores from baseline to 24 weeks (p < 0.0001 for all). Average steroid use per week also significantly reduced at 24 weeks (p = 0.0002). There was no significant gender difference. Mean changes in SDAI, HAQ and Patient Global Assessment scores for patients on steroids were significantly different from those not on steroids (p < 0.05 for all). At 24 weeks, 97 % of patients achieved ACR20 response demonstrating the efficacy of Reditux™ treatment. The treatment was well tolerated by patients without any clinically relevant serious adverse events over 24 weeks. Though limited by number of patients and retrospective in nature, this analysis serves as a real-world evidence of efficacy and safety of Dr. Reddy's rituximab (Reditux™) in the treatment of csDMARD-failed patients with RA over a 6-month period.

Smoking habits and attitudes of age concern volunteers.

As the population is ageing, health promotion is becoming increasingly important to prevent disease and disability. Cigarette smoking is strongly associated with excess mortality and smoking cessation even after the age of 65 years, improves health and lowers mortality. The voluntary sector is an under-utilised resource for health promotion to older people. Age Concern Cymru is the leading voluntary organisation in Wales involved in promoting 'healthy ageing'. The aim of this study was to determine the smoking habits and attitudes of older Age Concern volunteers. A questionnaire enquiring about smoking habits and attitudes was circulated to all volunteers aged 65 years and over attending age concern meetings in Wales between July and September 1999. Of 375 respondents (93% response rate) 16% were current-smokers, 58% ex-smokers and 26% life-long non-smokers. A significantly greater proportion of women were non-smokers. Significantly more ex-smokers (90%) and non-smokers (93%) compared with current-smokers (72%) believed that smoking causes heart disease (P<0.002). More ex-smokers (91%) and non-smokers (94%) than current-smokers (80%) believed smoking causes lung cancer (P<0.05). In conclusion, the majority of volunteers are currently non-smokers. Over 90% of ex-smokers and non-smokers believed in the deleterious effects of smoking on health. These volunteers could be utilised for smoking-cessation campaigns.