Rheumatoid arthritis (RA) patients in India can look forward to an efficacions medicine to alleviate their pain, thanks to successful clinical trials of what researchers describe as a blockbuster molecule.
The drug “Tofacitimb” got the approval of the US Federal Drug Authority in November last year, bringing cheers to millions of patients suffering from RA, a crippling auto-immune disease that affects the joints.
Teams of doctors and researchers have been conducting clinical trials at 350 sites, spread over 35 countries including India, and the results have been very encouraging, said Dr V Sarath Chandra Mouli, chief rheumatologist at Krishna Institute of Medical Sciences (Kims), one of the centres where the clinical trials are being conducted.
Tofacitimb, developed by global pharmaceutical major Pfizer, helped in the reduction of inflammation and progression of disease, Dr Mouli said. The trials revealed that the drug has good tolerance levels among the patients.
Pfizer has since applied for approval of the medicine with the Drugs Controller General of India (DCGI). At present, the drug is available only in the US market.“Rheumatoid arthritis requires lifelong treatment, and with Tofacitimb showing very good results, patients in India can look forward to an effective medicine to reduce their pain,” the rheumatologist said.
Kims, which is one of the 350 sites conducting the drug trials for the last four years, has reported excellent recovery rate among patients who have been put on the drug on a voluntary basis.
They are being administered the medicine free of cost.
“The treatment, which costs about $2,500 per month per patient, is being given to patients in our hospital free of cost. Pfizer is providing the drug free for clinical trials,” Dr Mouli said.
Over 20 patients in the age group of 18 to 65 years, most of them women, have been undergoing trial at Kims since 2008.
About the ethical questions being raised about clinical trials in India, Dr Mouli said that in the case of Tofacitimb, patient participation was voluntary. “We explain to the patients the research project in detail and only after they give their consent do we go ahead with the trials,” he said, adding there was a misconception that Indians were being used as guinea pigs by pharmaceutical giants for clinical trials.
It is estimated that one crore people in India suffer from rheumatoid arthritis.
The number may swell to three to five crore if all other forms of rheumatic problems are taken into consideration. This is an alarming figure for any country.
Despite such a high incidence, the public awareness about rheumatic diseases is very poor in the country.
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