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CORRECTED - J&J, Schering-Plough arthritis drug meets goals

(Corrects penultimate paragraph to show Remicade given once ever two months instead of weeks)

BOSTON, Nov. 7 (Reuters) - Johnson & Johnson JNJ.N and Schering-Plough Corp SGP.N said on Wednesday that their experimental drug golimumab was effective in clinical trials in reducing symptoms of psoriatic arthritis and ankylosing spondylitis -- conditions related to rheumatoid arthritis.

In two late-stage studies, golimumab met the main goals and significantly improved symptoms of both disorders compared to patients taking a placebo, according to data presented at the annual scientific meeting of the American College of Rheumatology in Boston.

Psoriatic arthritis combines the characteristics of arthritis and the skin disorder psoriasis, while ankylosing spondylitis is a progressive form of spinal arthritis that can cause fusing of the vertebrae.

Golimumab works by blocking an inflammatory protein known as tumor necrosis factor, or TNF.

In a 405-person trial of patients with psoriatic arthritis, 51 percent of patients receiving 50 milligrams of the drug and 45 percent of patients taking 100 mg saw their arthritis symptoms improve by at least 20 percent, compared with 9 percent of patients taking a placebo after 14 weeks.

At 24 weeks, 61 percent of patients who took the higher dose of golimumab achieved a 20 percent reduction in their symptoms, compared to 12 percent of patients who took a placebo. Of patients who took the lower dose, 52 percent achieved a 20 percent improvement, researchers said.

In a trial of 356 patients with active ankylosing spondylitis, 59 percent of patients receiving 50 mg of the drug and 60 percent of patients receiving 100 mg achieved at least a 20 percent improvement in their symptoms, compared with 22 percent of patients taking a placebo at 14 weeks.

At 24 weeks, 66 percent of patients receiving the higher dose of golimumab and 56 percent who took the lower dose achieved a 20 percent improvement in symptoms compared with 23 percent of patients receiving a placebo.

The drug is also in late stage trials as a treatment for rheumatoid arthritis with results expected next year.

J&J said it expects to file for marketing approval for all three indications in 2008.

Anti-TNF drugs are one of the most successful groups of all biologic medicines. They include Abbott Laboratories' ABT.N Humira, Amgen Inc's AMGN.O Enbrel and J&J's JNJ.N Remicade, which together generated sales of nearly $10 billion in 2006.

Side effects of golimumab were similar to those seen with other TNF-inhibitors, said Dr. Arthur Kavanaugh, professor of medicine at the University of California, San Diego, and lead investigator of the psoriatic arthritis trial.

Golimumab’s makers believe it will have a competitive edge over other drugs in the class as it is injected by the patient once a month. Rival Humira must be injected once every two weeks and Enbrel is injected once a week. Remicade is given once every two months intravenously at the hospital or doctor’s office.

The companies hope golimumab will also win approval to be given as an intravenous treatment once every three months. (Reporting by Toni Clarke, editing by Bill Berkrot/Gary Hill)

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