Bristol-Myers Rheumatoid Arthritis Drug Works in Mid-Stage Trial

Bristol-Myers Squibb Co.’s experimental rheumatoid arthritis drug reduced symptoms of the disease and was about as effective as a current standard treatment sold by AbbVie Inc., a study found.

In a trial of 418 patients, 78 percent of those who took Bristol-Myers’s clazakizumab with methotrexate reduced their symptoms by at least 20 percent, the New York-based company said today in a statement. That was twice the rate of patients who took only methotrexate, a generic treatment for the disease. Of patients taking methotrexate and Humira, AbbVie’s injectable drug that sold $9.27 billion last year, 76 percent had symptoms fall by at least 20 percent.

Bristol-Myers’s sales are returning to growth after patent expirations shrank revenue in the past five quarters, led by the loss of marketing exclusivity for the anti-stroke pill Plavix. New products, led by the company’s cancer and hepatitis C franchises, are emerging and may boost sales further.

“It’s encouraging, especially since they had a comparator arm there with Humira plus methotrexate,” said Grant Louie, a rheumatologist and professor of medicine at Johns Hopkins University School of Medicine. “It does appear to be comparable.”

The company is deciding whether to move the drug into the final of three stages of clinical trials usually required for approval before applying for marketing clearance, said Pushkal Garg, a Bristol-Myers’s head of immunoscience development.

Development Path

“We’re very excited about the results here, and we’re mapping out the next phases of the development plan,” he said in a telephone interview.

Rheumatoid arthritis causes inflammation of the joints, often in the hands and feet. It is thought to be caused by problems with the immune system, according to the U.S. Centers for Disease Control and Prevention in Atlanta. About 1.5 million people in the U.S. have it, according to the Arthritis Foundation.

Clazakizumab’s biggest difference may be in getting a portion of patients in remission from the disease, or reducing its symptoms severely, Garg said.

“Where we really see the unmet need for clazakizumab, is you have 70 percent or more of patients who don’t get into remission,” he said. “We really want to try and get patients into remission.”

Symptoms Reduced

The drug cut symptoms of the disease by 70 percent for 27 percent to 38 percent of patients in the study compared with 19 percent on Humira. Measures of remission were also greater on clazakizumab than on Humira, according to the study.

The data were released today as part of the American College of Rheumatology annual meeting in San Diego.

Future trials will need to show the drug’s side effects are manageable, especially since doctors are already familiar with treatments on the market. Patients in the study released today had pain at the injection sites at a higher rate than those taking Humira, and the drug also raised cholesterol levels and liver enzymes that could signal toxicity.

“That could raise concerns for the patient and the regulatory agency,” Louie said. “Often in the real world, patients say, ‘To heck with it,’ and discontinue medication instead of dealing with it.”

Bristol-Myers hasn’t touted clazakizumab much to investors, with executives focusing on the experimental drugs for cancer and hepatitis. If successful in final stage trials, it would compete with the multibillion-dollar drugs that currently dominate for rheumatoid arthritis, Humira and Enbrel, which is sold by Amgen Inc. and Pfizer Inc.

Drug Deals

Bristol-Myers bought the drug in 2009 from closely held Alder Biopharmaceuticals Inc. The deal gave Alder an initial cash payment of $85 million, and as much as $764 million in milestone payments and the potential for more than $200 million in payments and royalties if the drug gets to market.

Rheumatoid arthritis patients typically start treatment with methotrexate, a cheaply available generic drug. If methotrexate doesn’t work or becomes less effective, doctors can add a therapy such as like Humira or Enbrel. There’s no cure for the chronic disease.

Clazakizumab works through a pathway called IL-6, helping to block the inflammatory effects of rheumatoid arthritis. Basel, Switzerland-based Roche Holding AG has a related drug, Actemra, which sold $898 million last year. AbbVie is developing a drug that uses the IL-6 path, ALX-0061, which it licensed from Ablynx last month in a deal worth as much as $840 million.

The study didn’t offer data on another measure of disease control, called radiographic progression, that uses imaging to measure the breakdown in joints, Louie said. That may be an important measure for regulators when the decide whether to approve a drug.

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