Phase 3 studies show golimumab significantly improved signs and symptoms of rheumatoid...(ector of the Rebecca MacDonald Centre fo...)

Date:6/10/2008

ector of the Rebecca MacDonald Centre for Arthritis & Autoimmune Disease at Mount Sinai Hospital in Toronto, and lead study investigator. "Since some patients do not respond adequately to methotrexate alone, this combination therapy could prove to be a highly valuable treatment option based on these results."

Patients receiving golimumab also experienced improvement in physical function as assessed by the Health Assessment Questionnaire (HAQ). At 24 weeks, 68 percent of patients in the golimumab 50 mg dosing group and 72 percent of patients receiving golimumab 100 mg experienced clinically relevant improvement in physical function (improvement in HAQ score of at least 0.25 from baseline), compared with 39 percent of patients receiving placebo plus MTX (p<0.0001). HAQ assess the degree of difficulty a patient has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and other activities of daily living).

At week 14, 74 percent and 76 percent of patients in the golimumab 50 mg and 100 mg plus MTX groups, respectively, were classified as DAS28 (using C-reactive protein [CRP]) responders, compared with 52 percent of patients receiving MTX alone (p<0.001). Importantly, 35 percent and 32 percent of patients in the respective golimumab groups achieved remission based on DAS28 (CRP), compared with 13 percent of patients receiving placebo plus MTX (p<0.001). These improvements were sustained through six months.

In another Phase 3 study, GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE), MTX-nave patients treated with golimumab 50 mg or 100 mg in combination with MTX experienced improvement in signs and symptoms of arthritis as well as in disease activity. The study's primary endpoint was based on an intent-to-treat (ITT) analysis, which included all patients randomized in the study. However, three p
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Contact: Brian Kenney bkenney1@cntus.jnj.com 215-620-0111 Centocor, Inc. Source:Eurekalert

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