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June 7 (Reuters) - An experimental drug for rheumatoidarthritis developed by Johnson & Johnson andGlaxoSmithKline slowed joint damage and improvedsymptoms of the disease, meeting the main goals of a large, latestage trial, according to data released on Tuesday.
In the study of 1,670 patients who were not helped by olderdisease-modifying treatments, the injectable biotech drugsirukumab after one year led to significantly less joint erosionand joint space narrowing than a placebo, researchers found.
Using a scoring method to measure changes in joint damage asviewed by X-ray in which higher scores indicate greaterstructural damage, patients who received a placebo had a scoreof 3.69. That compares with a score of 0.50 for those whoreceived 50 milligrams of sirukumab every four weeks and 0.46for those who took 100 mg every two weeks.
The results, which were due to be presented at a Europeanrheumatology meeting in London on Saturday, were deemed byresearchers to be highly statistically significant.
Sirukumab also led to at least a 20 percent improvement insigns and symptoms of the condition after 16 weeks of treatmentat twice the rate of placebo. In the 50 mg group, 54.8 percentof patients experienced the improvement, while 53.5 percent ofthose who received the 100 mg dose saw at least 20 percentimprovement. That compared with 26.4 percent for placebo.
A 50 percent improvement in disease signs and symptoms wasexperienced by at least 30 percent of sirukumab patients versus12 percent for the placebo group.
"The results from this Phase III study showed significantinhibition of the progression of joint damage for sirukumab andimprovements in the pain and inflammation patients withrheumatoid arthritis experience when not adequately controlledwith traditional disease-modifying agents," Tsutomu Takeuchi,the study's lead researcher and a rheumatology expert from KeioUniversity in Tokyo, said in a statement.
Serious adverse side effects were higher in the groups thatreceived the J&J drug compared with placebo, at 11 percent for50 mg and 9.8 percent 100 mg for sirukumab versus 6.8 percentfor placebo.
Eleven patients in the study died, J&J said, including sevenfrom the sirukumab groups and three patients originally onplacebo who switched to sirukumab after week 18.
Long-term safety data is being collected and evaluated fromthe sirukumab Phase III program, J&J said.
(Reporting by Bill Berkrot; Editing by Bernard Orr)
