October 17, 2009 / 9:01 PM / 10 years ago

J&J's Simponi effective against joint damage-study

* Simponi helps inhibit joint damage at one year

* Simponi plus methotrexate tops methotrexate alone

* Effective in rheumatoid and psoriatic arthritis

NEW YORK, Oct 17 (Reuters) - Johnson & Johnson’s (JNJ.N) new rheumatoid arthritis drug, Simponi, when used in combination with the common treatment methotrexate was significantly more effective at inhibiting structural damage to joints than methotrexate alone, according to data from a late- stage study.

Simponi, which is administered once every four weeks by subcutaneous injection, was approved in the United States in April and earlier this month in Europe, where it will be sold by Schering-Plough Corp SGP.N.

Known chemically as golimumab, Simponi is a follow-up to J&J’s widely-used Remicade arthritis treatment. Both work by blocking an inflammation-causing protein known as tumor necrosis factor.

The Phase III, one-year study, to be presented at next week’s American College of Rheumatology scientific meeting in Philadelphia, tested the drug in patients with active rheumatoid arthritis (RA) and active psoriatic arthritis (PsA). The data could be used to allow J&J to expand claims on the drug’s label to include joint damage prevention, the company said.

After 52 weeks of treatment, RA patients who received 50 milligrams of Simponi plus methotrexate had statistically significantly less progression of structural damage than those on methotrexate alone, as measured by X-rays showing changes in joint destruction, including joint erosion and joint space narrowing, researchers said.

Using a scoring method in which higher scores indicate greater structural damage, the mean change from baseline in the Simponi group was 0.74 compared with an increase of 1.37 in the methotrexate group.

Among psoriatic arthritis patients, those who got 50 mg of Simponi plus methotrexate also showed significantly less progression of structural damage at week 24 compared with patients receiving just methotrexate, and the benefit was maintained through 52 weeks, researchers said.

“These data reveal important new insights into the efficacy of golimumab and its effect in altering the potential destructive nature of RA and PsA,” Dr Paul Emery, head of the Academic Unit of Musculoskeletal Medicine at the University of Leeds and study’s lead investigator, said in a statement.

Adverse events, including serious infections, were reported in a small percentage of patients and were relatively similar across all the patient groups in the study, researchers said. (Reporting by Bill Berkrot; editing by Andre Grenon)

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