Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs in XXXX : Results of the GO-MORE study in Spain.

@entity1 @entity1499 @entity309 @entity288
OBJECTIVES: To assess the efficacy and safety of golimumab in the 140 @entity1 included in Spain as the first part of the GO-MORE trial, a multinational study involving @entity1 with active @entity309 ( @entity309 ) despite treatment with different disease-modifying antirheumatic drugs (DMARDs). @entity1 AND METHODS: The @entity1 received subcutaneous golimumab 50mg once a month during 6 months. The primary endpoint was the percentage of individuals with a good or moderate EULAR DAS28-ESR response after 6 months of treatment. RESULTS: A total of 140 @entity1 were included. Of these, 76.4% had very active disease (DAS28-ESR>5.1). 76.4% were taking @entity1499 , 40.0% other DMARDs in monotherapy or combined, and 65.0% received @entity288 . After 6 months, 82.9% of the @entity1 showed a good or moderate EULAR response, 41.4% had low disease activity, and 30.7% were in remission. The percentage of responders one month after the first dose was 69.3%. The efficacy was similar in @entity1 treated with @entity1499 or other DMARDs, with different @entity1499 doses, with or without @entity288 , or in subjects who had failed one or more DMARDs. The response to golimumab was observed from the first dose. Golimumab was well tolerated and its safety profile was consistent with the findings of previous studies. Serious adverse events were reported in 11 @entity1 (7.9%). CONCLUSION: The addition of subcutaneous golimumab 50mg once a month to different DMARDs in @entity1 with active @entity309 yielded a moderate or good response after 6 months in 82.9% of the cases. The response was observed early, from the start of the second month, after a single dose of golimumab.
