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Exciting new treatment for Rheumatoid arthritis. posted by Dr. Badsha, Rheumatologist in Dubai, UAE

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NEW YORK (Reuters) Sep 08 – New data from a trial of Pfizer Inc’s investigational rheumatoid arthritis drug tofacitinib showed the medicine was as effective as Abbott Inc’s blockbuster injectable Humira (adalimumab), but more patients taking it had serious side effects.

Summaries of several late-stage trials, to be presented November at the annual American College of Rheumatology (ACR) scientific meeting in Chicago, were released on Thursday.

The new tofacitinib data confirmed earlier findings that the drug was effective and in general well tolerated.

The incidence of overall adverse events was similar for both drugs, but the proportion of patients who developed serious side effects, though small, was numerically higher in the tofacitinib groups.

“Impressive efficacy was demonstrated, with focus now expected to be on safety leading into its regulatory review,” Jeffrey Holford, an analyst at Jefferies & Co, said in a research note. “While the market was expecting a similar efficacy between the higher dose of tofacitinib and Humira, the strong performance of the lower dose is impressive.”

Pfizer plans to seek approval of the medicine by the end of the year.

Data from the 12-month ORAL Standard trial comparing tofacitinib and Humira involved 717 patients with moderate to severe disease who continued to take methotrexate.

One group took 5 mg of the Pfizer drug twice a day, a second group took 10 mg twice a day, while a third group received Humira injections every two weeks. A fourth group of patients received a placebo.

The effectiveness of tofacitinib and Humira was numerically similar by all measures, although the study was not designed to definitively assess superiority of one drug over the other.

“Based on the totality of the tofacitinib RA clinical development program, Pfizer believes the risk/benefit profile supports regulatory submission for both the 5 and 10 mg dose,” Pfizer spokeswoman Victoria Davis said.

Data also became available for the first time on Thursday on the incidence of overall mortality and infections across numerous late-stage trials of the Pfizer medicine, and from longer-term follow-up of patients.

That pooled analysis, involving more than 6,200 patients, showed a mortality rate with tofacitinib of 0.572 deaths per 100 patient years in the Phase III trials, and 0.641 deaths per 100 patient years in the long-term evaluations.

In all, 12 patients died out of more than 3,000 who received tofacitinib in the Phase III trials, with deaths of another 20 patients seen among more than 3,200 who were followed in longer-term studies.

Pfizer said the death rates were consistent with those typically seen with standard treatments meant to slow the progress of arthritis symptoms.

Tofacitinib belongs to a new class of drugs known as JAK inhibitors that block a protein associated with inflammation.

It would compete against a lucrative family of biotech treatments that block tumor necrosis factor. These treatments include Humira, one of the world’s biggest selling medicines, as well as Johnson & Johnson’s Remicade (infliximab) and Enbrel (etanercept), which is sold by Amgen Inc and Pfizer.

This medication does not have FDA approval and is not available for use in the UAE yet.

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This web site is run by an Arthritis Specialist based in Dubai, United Arab Emirates. On this site you will find news about the latest in arthritis, information about research results in the field, tips and information and diet and exercise, and much more.

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