Phase 3 Data Show Efficacy of Golimumab in Patients with Active Rheumatoid Arthritis Previously Treated with Anti-TNF Agents

Wednesday, June 11, 2008 General News
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PARIS, June 11 Findings presented for the first time froma novel, randomized, double-blind, placebo-controlled Phase 3 study showedthat patients with moderately-to-severely active rheumatoid arthritis (RA) whowere previously treated with anti-tumor necrosis factor (TNF)-alpha agents,experienced significant improvements in signs and symptoms and physicalfunction after receiving every four-week subcutaneous injections of golimumab(CNTO 148) 50 mg or 100 mg. Investigators also reported that the patients whoreceived golimumab showed sustained improvements in disease activity andphysical function through six months. The study was presented at the EuropeanLeague Against Rheumatism (EULAR) Annual Congress of Rheumatology.

"Our findings show that golimumab holds great promise in various RApatient populations, including those patients who have previously discontinuedother TNF inhibitors," said Josef S. Smolen, M.D., professor and Chairman,Department of Rheumatology, Medical University of Vienna and lead studyinvestigator. "Golimumab may provide an appropriate treatment option to themany people facing the consequences of this debilitating disease."

In the study, GOlimumab After Former anti-TNF Therapy Evaluated in RA(GO-AFTER), 35 percent and 38 percent of patients receiving golimumab 50 mgand 100 mg, respectively, achieved the primary endpoint of at least 20 percentimprovement in arthritis symptoms (ACR 20) at week 14, compared with 18percent of patients receiving placebo (p<0.001). These results weremaintained through six months. Importantly, among the 58 percent of patientswhose prior anti-TNF-alpha therapy had been discontinued due to lack ofefficacy, 36 percent receiving golimumab 50 mg and 43 percent receivinggolimumab 100 mg achieved ACR 20 as compared to 18 percent of patients treatedwith placebo (p=0.006 for 50 mg group, p<0.001 for 100 mg group,respectively). Patients in each study group continued to receive stable dosesof methotrexate (MTX), sulfasalazine (SSZ) and/or hydrochloroquine (HCQ) ifthey were receiving them at baseline.

"When treating patients with progressive rheumatoid arthritis, our goal isto reduce pain and improve physical function," said Jonathan Kay, M.D.,Director, Clinical Trials, Rheumatology Unit, Massachusetts General Hospital;Associate Clinical Professor of Medicine, Harvard Medical School and leadstudy investigator. "We are encouraged by the results of these trials whichsuggest that golimumab may offer a significant benefit to a growing populationof RA patients with prior TNF inhibitor experience."

Patients in both treatment groups receiving golimumab also experiencedsignificant improvement in physical function and disease activity through sixmonths as measured by the Health Assessment Questionnaire (HAQ) and theDisease Activity Score (DAS28), respectively. At 24 weeks, 52 percent ofpatients in the combined golimumab dosing group experienced a clinicallyrelevant improvement in physical function (improvement in HAQ score of atleast 0.25 from baseline), compared with 34 percent of patients receivingplacebo (p<0.001). HAQ assesses the degree of difficulty a patient has inaccomplishing tasks in eight functional areas (dressing, arising, eating,walking, hygiene, reaching, gripping and other activities of daily living).Additionally, at six months, more than half of patients in the combinedgolimumab group were classified as DAS28 responders (using either C-reactiveprotein [CRP] or erythrocyte sedimentation [ESR] rate), compared with 23percent and 25 percent of placebo-treated patients, respectively, indicatingimprovements in levels of disease activity.

Additionally, two separate Phase 3 studies, which were also presented atEULAR, evaluated golimumab in RA patients who had active RA despite MTXtherapy (GO-FORWARD), and golimumab in RA patients who had not previously beentreated with MTX (GO-BEFORE).




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