Washington, June 26 (IANS) The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) -- used for arthritis -- for the treatment of hospitalised patients with Covid-19.Under the EUA, the drug can be administered only ot hospitalised adults and pediatric patients (2 years of age and older), receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).However, Actemra is not authorised for use in outpatients with Covid-19, the FDA said in a statement.Clinical trials showed that administering Actemra to hospitalised Covid-19, in addition to routine care which included corticosteroid therapy, reduced the risk of death as well as decreased the amount of time patients remained hospitalised.The risk of patients being placed on ventilators or death was also decreased."Although vaccines have been successful in decreasing the number of patients with Covid-19 who require hospitalisation, providing additional therapies for those who do become hospitalised is an important step in combating this pandemic," said Patrizia Cavazzoni, MD, Director of the FDA's Center for Drug Evaluation and Research.Actemra is a monoclonal antibody that reduces inflammation and is given by intravenous infusion that is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis.In the case of Covid-19 infection, the immune system can become hyperactive, which may result in worsening of disease. But, Actemra does not directly target SARS-COV-2.Based on the FDA's review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that Actemra may be effective in treating Covid-19 for the authorised population.The data supporting this EUA for Actemra are based on four clinical trials. All four clinical trials contribute to the FDA's understanding of Actemra for the treatment of Covid-19.Common side effects of Actemra observed in the Covid-19 trials include constipation, anxiety, diarrhoea, insomnia, hypertension and nausea. The EUA was issued to American biotechnology Genentech, a subsidiary of Swiss multinational healthcare Roche, FDA said.--IANSrvt/in
New Delhi, June 20 (IANS) In India, yoga is celebrated as an ancient tradition, which has grown into a global phenomenon. As India gears up for International Yoga Day on June 21, a research paper released by an expert at All India Institute of Medical Sciences (AIIMS) said, yoga can be used as an adjunct therapy in the management of severe arthritis.
Dr Rima Dada, Prof Lab for Molecular Reproduction and Genetics, Department of Anatomy at AIIMS, said, yoga improves clinical outcome in Rheumatoid arthritis (RA), and decreases systemic inflammation by its beneficial effects on psycho-neuro-immune axis and normalization of dysregulated transcripts.
The research paper titled 'yoga impact on autoimmune arthritis' is based on a study done in collaboration with Dr Uma Kumar, Professor and Head of the Department of Rheumatology. Dada emphasized yoga is an integrative health strategy which focusses on both physical and psychological aspects of a disease.
Dada claimed the study on the impact of yoga in 66 RA patients supports adding yoga as an adjunct therapy to treat the chronic debilitating autoimmune disease.
The results of the study suggested that there was a decrease in disease activity after yoga practice, which was associated with a significant reduction in inflammatory cytokines, the elevation of mind-body communicative markers, and normalization of various transcript levels, which improved quality of life. "Despite lack of a cure, the disease may be controlled by yoga-based lifestyle interventions which improves joint flexibility and reduces pain. Yoga significantly improves and reduces the psycho-somatic symptoms, pain perception, disability quotient, joint flexibility, range of motion, posture, muscle strength, coordination, and disease activity", said the study.
Dada emphasized that this mind-body intervention is the need of the hour in the age of super specialization. "Yoga holds the immense potential to be an adjunct therapeutic regimen in RA patient and has tremendous rehabilitative potential", added Dada.
The findings indicated that yoga plays a role in facilitation of mind's capacity to overcome disease and improve physical symptoms via a variety of downstream pathways.
New York, June 17 (IANS) An arthritis drug -- Tofacitinib -- developed by US biopharmaceutical Pfizer has shown to be effective in reducing the risk of death or respiratory failure in hospitalised adult patients with Covid-19 pneumonia who were not on ventilation, according to a study.Tofacitinib belongs to a class of drugs called Janus kinase (JAK) inhibitors. It is approved in the US to treat conditions including rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.The efficacy of Tofacitinib was tested on 289 patients hospitalised with severe Covid across 15 locations in Brazil. Half of these patients received 10 mg twice daily plus standard of care which includes glucocorticoids, while the other half were prescribed placebo twice daily plus standard of care for up to 14 days.The results published in the New England Journal of Medicine showed that after 28 days, tofacitinib lowered the death or respiratory failure by 63 per cent. Among patients on tofacitinib, only 18.1 per cent had the incidence of death or respiratory failure compared to placebo (29 per cent).Deaths in the tofacitinib group occurred in 2.8 per cent of patients and in 5.5 per cent of those in the placebo group.Serious side effects occurred in 14.1 percent in the tofacitinib group and in 12 percent in the placebo group."We are encouraged by the initial findings of our randomized trial of tofacitinib in patients hospitalised with Covid-19 pneumonia," said Otavio Berwanger, Director of the Academic Research Organisation, Hospital Israelita Albert Einstein, which coordinated the trial in collaboration with Pfizer."These results provide new information which indicates that the use of tofacitinib when added to standard of care, which includes glucocorticoids, may further reduce the risk of death or respiratory failure in this patient population," Berwanger added.However, it is important to note that tofacitinib has not been approved or authorised for use by any regulatory authority worldwide for the treatment of Covid-19 and tofacitinib should not be used in patients with an active serious infection, the researchers said.--IANSrvt/vd
Arthritis drug tocilizumab has been found to reduce the risk of death among patients with severe Covid-19 in a phase 3 trial conducted in India.
However, the findings, published in the journal The Lancet Respiratory Medicine, does not support the routine use of tocilizumab in adults with Covid-19.
Explaining the results, the National Lead investigator and Chairman of the Medanta Liver Institute, Arvinder Soin said that this was the first phase 3 study to demonstrate that while routine use of tocilizumab on all hospitalised Covid patients was not warranted, the drug improved survival among patients with severe Covid-19.
Several well known public and private tertiary care hospitals from 10 Indian cities participated in the study.
A total of 180 patients were recruited, 90 of whom received tocilizumab (TCZ) and standard care, whereas the other 90 received only standard care.
Steroids and remdesivir once allowed by the MoHFW, were administered to patients in both groups.
While there was no difference in mortality and need for ventilation among the two groups of patients when moderate and severe categories of patients were considered together, a subgroup analysis of the severe patients in the two groups showed a lower mortality (8/50; 16 per cent) among those who received Tocilizumab compared to those who did not (14/41; 34 per cent) at 28 days.
Tocilizumab was shown to be safe as the reported adverse events did not differ between the tocilizumab and standard care arms, said Soin.
Elaborating on the use of tocilizumab, Soin said given the conflicting results of the previous studies, millions were wasted last year on indiscriminate use of tocilizumab, since the exact stage of the disease in which to use the drug was not clear.
So, this study plugs an important gap in knowledge on Covid treatment and gives a clear direction on the timing of tocilizumab in Covid treatment.
"This research is instrumental in giving the medical fraternity clarity on when to use TCZ in Covid," said Naresh Trehan, Managing Trustee of the Medanta Institute of Education and Research, and Chairman & Managing Director, Medanta.
"We have demonstrated that, even during a pandemic, it is possible to conduct a randomised controlled trial despite the multiple challenges and constraints encountered".
In their paper, the investigators, brought out the difficulties encountered in conducting trials during the pandemic.
They were impeded by challenges such as changing standard care, administration of off-label treatments, rapidly evolving understanding of pathogenesis and treatment, multiple trials competing for participants, media hype, and the publication of non-peer reviewed reports. (IANS)
Thiruvananthapuram- A team of researchers from the Department of Biochemistry, University of Kerala with the support of the Kerala State Council for Science, Technology and Environment (KSCSTE), has come out with a significant work that has given scientific validation to three classical ayurvedic kashayams. The three are Balaguluchiadi, Punarnavadi and Gugguluthiktaam -- used in the treatment of rheumatoid arthritis based on molecular signalling studies.
According to reports, across the world around one per cent of the population is affected by this ailment and has to rely mostly on conventional medicines, which have side effects.
Kashayam means a decoction which is an extract of a single herb or group of herbs.
I.S. Aswathy, who was part of the study team, said a major problem faced by classical ayurvedic medicines is lack of scientific evidence in spite of their efficacy.
"We were fortunate enough to get a project to the tune of Rs 26 lakhs from KSCSTE and the study took us around 42 months," said Aswathy.
She said the study was conducted in four phases in rats after inducing rheumatoid arthritis and the treatment duration was based on standard protocol.
"Severity of pain and inflammation associated with rheumatoid arthritis were decided by the infiltration of so many pro-inflammatory cytokines, lymphocytes, oxidants etc. By this study we were able to find that kashayams exerted therapeutic efficacy in the management of rheumatoid arthritis by regulating pro anti-inflammatory cytokines balance, increasing antioxidant level and by immune modulation," said Aswathy.
The study team that was guided by A. Helen, Professor and Mentor, has published their work in the international peer reviewed Journal of Ayurveda and integrative medicine and two papers are under review.
The highlight of the study is that while all these three kashayams are available in the market there was no scientific validation, which the study team has been able to do.
The team instead of relying on the readily available kashayams, decided to make their own under the guidance of Ayurveda physician Sukumara Varier of Kottakal Arya Vaidyasala.
The team prepared the decoction from 28 different forms of herbs and the major difference was they did not add any substance, which is added to increase the shelf life.
With regard to the outcome, Aswathy said "our attempt was to give better hope to patients suffering from rheumatoid arthritis besides a vehicle to enrich traditional knowledge with well documented scientific background for the sake of mankind." (Agency)
Read More ► Promotion of Ayurvedic Medicines in the country
Sao Paulo- Contrary to a few studies that earlier suggested benefits from an arthritis drug for patients with severe or critical Covid-19 infection, a new study indicates that it is not better than standard care alone.
According to the researchers, including Regis G Rosa from Hospital Moinhos de Vento in Brazil, there was an increased number of deaths at 15 days in patients receiving an arthritis drug -- tocilizumab -- that resulted in the trial being stopped early.
These results contradict earlier observational studies suggesting benefit from tocilizumab. However, observational effects are limited by a high risk that they may be due to other unknown (confounding) factors -- and some studies have not yet been peer-reviewed or published in a medical journal, the researchers said in a paper published in The BMJ journal.
Tocilizumab blocks a specific part of the immune system (interleukin 6) that can go into overdrive in some patients with Covid-19.
According to the team, doctors think this might help lessen the body's inflammatory response to the virus and avert some of the more dire consequences of the disease, but its effects are not well defined.
To test this theory, researchers conducted a randomised controlled trial involving 129 Covid-19 patients with an average age of 57 years and compared tocilizumab plus standard care with standard care alone.
Patients were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two chemicals linked to inflammation in their blood.
The study participants were randomly divided into two groups -- 65 received tocilizumab plus standard care and 64 received standard care alone. All patients were monitored for 15 days.
By day 15, 18 (28 percent) patients in the tocilizumab group and 13 (20 percent) in the standard care group were receiving mechanical ventilation or had died.
Death at 15 days occurred in 11 (17 percent) patients in the tocilizumab group compared with 2 (3 percent) in the standard care group. (IANS)
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