Pfizer says patient died in oral RA drug study

Apr 22, 2011

(AP) -- Pfizer Inc. confirmed that one patient who was taking its drug candidate tofacitinib, a pill designed to treat rheumatoid arthritis, died during a recent clinical trial and said the death was connected to the drug.

The world's largest drugmaker said the patient died of . Three other patients who were treated with tofacitinib during the study died as well, but those deaths were not determined to be drug-related. Two of those deaths occurred several weeks after the patients stopped taking tofacitinib. Tofacitinib, formerly called tasocitinib, is being tested as a treatment for moderate to severe rheumatoid arthritis, a that causes inflammation, usually of the hands and feet.

More than 1,000 patients have taken tofacitinib during , and Pfizer said late Thursday that overall death rate for patients in those studies is similar to what has been observed in other biologic treatments for rheumatoid arthritis.

The late-stage trial was called ORAL Sync. Pfizer said in March that tofacitinib met its main goals in the 792-patient study. The patients received either 5 or 10 milligrams of the drug twice per day. Some patients received a placebo. The trials involved patients with moderate to severe active rheumatoid arthritis who have not been helped by an older class of drugs including methotrexate. Pfizer will present full results from the ORAL Sync trial on May 27 at a conference of the European League Against .

Earlier this month Pfizer said the drug met its goals in a separate late-stage trial.

Pfizer said the other deaths included a patient who died of acute , one death caused by brain injury following trauma, and one case of worsening rheumatoid arthritis. The death occurred 22 days after the patient stopped taking tofacitinib, and the patient who died of worsening rheumatoid arthritis had stopped taking tofacitinib six weeks earlier.

Analysts downplayed the report, saying the deaths are not unusual in studies of rheumatoid arthritis drugs. Credit Suisse analyst Catherine Arnold said the death rates in studies of tofacitinib are similar to approved therapies like Humira and Simponi, made by Abbott Laboratories and Johnson & Johnson, respectively. Arnold said that, according to , there is some evidence the patient whose death was connected to tofacitinib had pre-existing lung disease. However the patient did not have a diagnosed lung disease.

Citi Investment Research analyst John Boris said investors were more likely to focus on the patient who died of acute heart failure. He said rheumatoid arthritis drugs like Humira, Simponi and Enbrel are restricted in patients with a heart failure because is linked to the disease and because there is evidence that those drugs can worsen congestive heart failure.

Boris said it's possible that drugs like tofacitinib have a similar effect. He still expects the drug will eventually be approved and reach $800 million in annual sales.

Humira, Simponi and Enbrel are all injectable drugs that work by suppressing an immune system cell called TNF-alpha, or tumor necrosis factor alpha. Tofacitinib blocks janus kinases, a type of enzyme that is involved in inflammatory diseases and other illnesses.

The most common side effects of treatment with the drug have included bronchitis, headache, infections, and gastrointestinal symptoms like nausea, vomiting, and diarrhea. More serious side effects in a mid-stage trial included lower levels of a type of white blood cell called neutrophils, higher cholesterol levels, and increased creatinine levels.

Explore further: FDA OKs Cubist antibiotic for serious infections

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Misdiagnosis of rheumatoid arthritis

Mar 03, 2008

In an article recommended by Annelies Boonen of Faculty of 1000 Medicine, researchers look at the way rheumatoid arthritis is diagnosed by analysing the administrative databases used by physicians in Quebec.

Latest rheumatoid arthritis drugs compared

Apr 17, 2008

Findings published today in the open access journal BMC Musculoskeletal Disorders shows that the latest class of drugs used to treat rheumatoid arthritis (RA) are better than standard anti-inflammatories.

Recommended for you

FDA OKs Cubist antibiotic for serious infections

Dec 20, 2014

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

Xtoro approved for swimmer's ear

Dec 18, 2014

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

Dec 18, 2014

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.