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.

Is Mucormycosis an inevitable complication of Covid-19 in India?

Mucormycosis or black fungus infection is a less common disease but highly fatal infection, infecting the immunocompromised individuals. The site of predilection of the fungus is found to be lungs and brain in addition to its sequestration in sinusoidal spaces. Presently with the ongoing COVID 19 pandemic, the prevalence of this infection is found to be high in the Indian population. The fungus establishes itself by affecting the compromised immune system of an individual and thereby making the individual susceptible to other diseases/infection. The reasons attributed to the sudden upsurge are steroidal therapeutics abuse, tocilizumab therapy and diabetes mellitus.To avert the cytokine storm, the medical health workers are necessitated to include steroid drugs in COVID 19 treatment protocol however inclusion of these drugs in patients who do essentially require steroids can have their immune system debilitated and permit the invasion of this fungus. According to International Diabetes Federation (IDF), 77 million Indians are known to be diabetic, cautioning the physicians to be vigilante of the impending black fungus infection in the event of COVID19 affliction in such individuals. There is causal relationship between anti-hyperglycemic drugs and weakened immune system and opportunity for the fungus invasion. This review attempts to explain the inter-relatedness of COVID19 infection, its treatment and eventual black fungus infection risk.

Is Mucormycosis an inevitable complication of Covid-19 in India?

ABSTRACT Mucormycosis or black fungus infection is a less common disease but highly fatal infection, infecting the immunocompromised individuals. The site of predilection of the fungus is found to be lungs and brain in addition to its sequestration in sinusoidal spaces. Presently with the ongoing COVID 19 pandemic, the prevalence of this infection is found to be high in the Indian population. The fungus establishes itself by affecting the compromised immune system of an individual and thereby making the individual susceptible to other diseases/ infection. The reasons attributed to the sudden upsurge are steroidal therapeutics abuse, tocilizumab therapy and diabetes mellitus.To avert the cytokine storm, the medical health workers are necessitated to include steroid drugs in COVID 19 treatment protocol however inclusion of these drugs in patients who do essentially require steroids can have their immune system debilitated and permit the invasion of this fungus. According to International Diabetes Federation (IDF), 77 million Indians are known to be diabetic, cautioning the physicians to be vigilante of the impending black fungus infection in the event of COVID19 affliction in such individuals. There is causal relationship between anti-hyperglycemic drugs and weakened immune system and opportunity for the fungus invasion. This review attempts to explain the inter-relatedness of COVID19 infection, its treatment and eventual black fungus infection risk.