Deaths reported in Pfizer arthritis trial
pharmafile | April 26, 2011 | News story | Research and Development, Sales and Marketing | Pfizer, rheumatoid arthritis, tofacitinib
Four deaths have been reported in a late-stage study of Pfizer’s arthritis drug tofacitinib.
Three of the deaths are thought to be unrelated to the trial, but the fourth, attributed to respiratory failure, was reported by the trial investigator as being ‘study drug related’.
The findings were reported in an abstract of Pfizer’s ORAL Sync study of tofacitinib that will be presented at the European League against Rheumatism (EULAR) conference in London next month.
The phase III study involved 792 patients taking a 10mg dose of the drug and Pfizer said the mortality rate from all causes across the tofacitinib programme, including the ORAL Sync study, was within the range of rates reported for biologic therapies for RA.
News of the patient deaths cames just one week after Pfizer announced positive results from ORAL Scan study showing tofacitinib met all its primary endpoints at the 10mg dose.
Pfizer said the three deaths that investigators determined not to be study drug-related involved one case of brain injury following trauma three weeks after the trial, one case of worsening RA 42 days after discontinuation of study drug, and one case of acute heart failure.
Shares in Pfizer fell 3% on the news but shares in Abbott, which markets the blockbuster RA drug Humira, were boosted by 2 per cent.
Analysts have been predicting multi-billion dollar sales for tofacitinib and Pfizer is hoping it will not only replace revenues from its aging arthritis drug Enbrel, but also eventually challenge Humira – which made sales of over $6.5 billion last year – for significant market share.
Ben Adams
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