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New treatment for Rheumatoid arthritis

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An FDA advisory committee has voted 8-2 in favor of recommending approval of the
oral JAK inhibitor tofacitinib for the treatment of rheumatoid arthritis.
The agency’s Arthritis Advisory Committee voted Wednesday that the efficacy and
safety data support the use of tofacitinib for adult patients with moderately to
severely active rheumatoid arthritis who have had an inadequate response to one
or more disease-modifying anti-rheumatic drugs.
The panel was unanimous in its assessment of the drug’s overall efficacy. “The evidence was compelling and
was at least as good as for other biologics,” said panelist Maria E.
Suarez-Almazor, MD, PhD, of MD Anderson Cancer Center in Houston.
The efficacy was demonstrated in five phase III studies in which the primary
endpoint was met, showing American College of Rheumatology 20% response rates
ranging from 17% to 33% for the 5 mg dose and from 23% to 39% for the 10 mg
dose.
“Statistically significant increases were seen on ACR20, 50, and 70
response rates in all five studies,” said Nikolay Nikolov, MD, an FDA clinical
reviewer.
Less clear was the efficacy as demonstrated on radiographic
outcomes, which were assessed in only one study.
Analysis of this structural outcome was hampered by the fact that very little radiographic progression was
seen in the placebo group.
In addition, the change in modified total Sharp
scores seen in the 10 mg group appeared to be driven by one or more statistical
outliers, and the small effect size was influenced by missing data and
imputation methods.
“Radiographic outcome studies are difficult to do with
limitations on the duration of placebo controls,” said panel member David
Blumenthal, MD, of Case Western Reserve University in Cleveland.
“We don’t need certainty about radiographic outcomes today. That can be followed during
postmarketing,” Blumenthal added.
There also was considerable discussion about safety concerns that were raised in the phase III trials.
One area of concern was serious infections, which were seen at a rate of three per 100
patient-years, and most commonly were pneumonia and skin and soft tissue
infections.
There also were 12 cases of tuberculosis, mostly in countries
where the incidence is high, and 19 cases of serious herpes zoster.
Richard Riese, MD, PhD, of Pfizer noted that the company intends to have an action plan
for zoster, in which immunization will be encouraged and follow-up data
collected

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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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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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