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Data From Two Phase 3 Studies Show Anti-TNF Golimumab Significantly Improved Signs and Symptoms of Rheumatoid Arthritis

Wednesday, June 11, 2008 General News
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PARIS, June 11 Findings from two new Phase 3 studiesshowed that patients receiving every four-week subcutaneous injections ofgolimumab (CNTO 148) 50 mg and 100 mg and weekly methotrexate (MTX)experienced significant improvements in the signs and symptoms of rheumatoidarthritis (RA) as well as in physical function and disease activity, with somepatients achieving remission as measured by Disease Activity Score (DAS28).Findings from two multicenter, randomized, double-blind, placebo-controlledPhase 3 studies showed the efficacy of golimumab in two important populations- MTX-naive patients and patients with active RA despite ongoing treatmentwith MTX. These data were presented at the European League Against Rheumatism(EULAR) Annual Congress of Rheumatology. Golimumab is currently in the mostcomprehensive initial Phase 3 development program to date for an anti-tumornecrosis factor (TNF)-alpha biologic therapy with ongoing studies for thetreatment of RA, psoriatic arthritis and ankylosing spondylitis.
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In the study, GOlimumab FOR subjects With Active RA Despite MTX(GO-FORWARD), both the 50 mg and 100 mg doses of golimumab were studied inpatients whose disease was active despite ongoing treatment with MTX. At week14, 55 percent of patients receiving golimumab 50 mg plus MTX and 56 percentreceiving golimumab 100 mg plus MTX achieved at least 20 percent improvementin signs and symptoms of RA (ACR 20), compared to 33 percent of patientsreceiving placebo and MTX (p<0.01 and p<0.001, respectively). Improvementswere seen as early as first clinical assessment, which was four weeks afterthe first golimumab injection, and generally continued to improve over time.
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"The data in this study demonstrate that golimumab is beneficial inimproving numerous disease parameters, including inducing remission, inpatients whose disease was active despite ongoing treatment withmethotrexate," said Edward Keystone, M.D., FRCPC, director of the RebeccaMacDonald Centre for Arthritis & Autoimmune Disease at Mount Sinai Hospital inToronto, and lead study investigator. "Since some patients do not respondadequately to methotrexate alone, this combination therapy could prove to be ahighly valuable treatment option based on these results."

Patients receiving golimumab also experienced improvement in physicalfunction as assessed by the Health Assessment Questionnaire (HAQ). At 24weeks, 68 percent of patients in the golimumab 50 mg dosing group and 72percent of patients receiving golimumab 100 mg experienced clinically relevantimprovement in physical function (improvement in HAQ score of at least 0.25from baseline), compared with 39 percent of patients receiving placebo plusMTX (p<0.0001). HAQ assess 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).

At week 14, 74 percent and 76 percent of patients in the golimumab 50 mgand 100 mg plus MTX groups, respectively, were classified as DAS28 (usingC-reactive protein [CRP]) responders, compared with 52 percent of patientsreceiving MTX alone (p<0.001). Importantly, 35 percent and 32 percent ofpatients 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 theFirst-line Option in the treatment of Rheumatoid arthritis of Early onset(GO-BEFORE), MTX-naive patients treated with golimumab 50 mg or 100 mg incombination with MTX experienced improvement in signs and symptoms ofarthritis as well as in disease activity. The study's primary endpoint wasbased on an intent-to-treat (ITT) analysis, which included all patientsrandomized in the study. However, three patients did not r
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