New Rheumatoid Drug Causes Death in Trials
Four fatalities during a study of Pfizer’s brand new rheumatoid arthritis pill will be pored over at a medical meeting in London this week, as doctors weigh the drug’s chances of upending present clinical practice.
Tofacitinib has the potential to affect the rheumatoid arthritis market — presently dominated by multibillion-dollar injection therapy — by offering sufferers a more hassle-free twice-daily pill.
But the experimental drug’s opportunities have been clouded by safety concerns following reports that 4 individuals passed away after using it in a late-stage Phase Iii study.
Joel Kremer of Albany Medical College, the primary investigator for that study, told Reuters that this number of deaths had not been uncommon, because of the user profile of patients involved.
Pfizer themselves said last month that 3 of the deaths were based on local investigators not to ever be study related, leaving only one case of a 58-year-old U.S. individual with respiratory system infection linked to the drug.
However deciding causality isn’t easy.
Kremer said it seemed clear a couple of the additional fatalities — one because of brain trauma and one brought on by heart failure in a Chinese patient with valvular illness — were not associated with tofacitinib, but the particular case of a 48-year-old Russian patient was less certain.
The Russian individual, on the lower 5 milligram dose from the drug, died 42 days after stopping therapy from a respiratory system complication.
Outcomes of the research can be presented in a news conference on Wednesday, in front of presentation to the once-a-year conference associated with the European League Against Rheumatism (EULAR) on Friday.
Headline findings in March previously declared the trial a success and Kremer said the drug’s effectiveness was “in the same ballpark” as being injected biotech drugs, such as Abbott’s $6.5 billion-a-year smash hit Humira.
The 792-patient trial examined 2 dosages of tofacitinib against placebo in people with rheumatoid arthritis who failed to respond to an existing disease modifying anti-rheumatic drug.
Significant and sustained reactions were observed inside a couple weeks and, after six months, 58.3 % of patients on the higher 10 mg dose had a 20 percent improvement in symptoms, such as swollen joints, discomfort plus disability.
Georg Schett, head of rheumatology and immunology at the University of Erlangen-Nuremberg and a member of EULAR’s scientific committee, who was not active in the study, said tofacitinib looked encouraging but safety would be a vital factor.
An infection danger and elevated cholesterol — a possible issue for heart safety — are among the drug’s identified side effects.
Pfizer hopes to capture a large chunk of the rheumatoid arthritis marketplace using its so-called JAK inhibitor pill, which works by obstructing signals from entering cells that would activate inflamation related responses.
Analysts, on average, have predict annual tofacitinib sales of $1.1 billion by 2015, based on Thomson Reuters Pharma.
It should be filed for approval towards the end of 2011 and Pfizer thinks it has a wholesome lead over rivals.
Still, the U.S. drugmaker have their work cut out to displace successful injected drugs like Humira, Johnson & Johnson’s Remicade and Amgen’s Enbrel.
At the same time, other businesses are going after Pfizer with rival JAK inhibitors and AstraZeneca also offers another kind of oral arthritis drug in development called a SYK inhibitor.
Doesn’t exactly sound like the best solution, does it? Why not take the risk out of your rheumatoid arthritis treatment and ditch the drugs and use a natural and holistic approach.