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Anti-TNF Golimumab Continues to Show Promise in Phase II Rheumatoid,Arthritis Study

trials in combination with the EULAR response criteria. DAS 28 measures, the number of swollen joints and tender joints (assessed using 28-joint counts ), inflammation and overall disease activity including measurement of serum C-reactive protein (CRP) levels. The DAS28 provides a
number on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis in the patient. A DAS 28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by A DAS28 lower than 2.6 indicates remission has been achieved

American College of Rheumatology 20 (ACR20) is utilized to determine improvement in arthritis signs symptoms. ACR20 represents an improvement of at least 20 percent in tender joint count and swollen joint count and at least 20 percent improvement in 3 out of the 5 end points: acute-phase reactant, patient pain assessment, physician global assessment, patient global assessment, and patient self-addressed disability. ACR50 and ACR70 represent improvements of 50 and 70 percent.

Golimumab was generally well tolerated in the study through week 52. Serious adverse events (AEs) reported prior to crossover at week 20 were eight percent for the combined golimumab groups compared with six percent for the placebo group. Through week 20, serious adverse events were reported for 8.8% of the subjects in the combined golimumab plus methotrexate groups and 5.9% in the placebo plus methotrexate group. Through week 52, at least 1 serious adverse event was reported for 16.1% of subjects in the combined golimumab plus methotrexate groups; serious adverse events were reported in three subjects after cross over to infliximab plus methotrexate. After crossover from weeks 20 to 52, serious AEs were seven percent in the combined golimumab groups, compared to 12 percent in the control group. No deaths, cases of tuberculosis or other opportunistic infections were reported through 52 weeks, and seri
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