Background/Purpose: This study evaluated golimumab (GLM) as add-on therapy in patients with active RA despite treatment with non-biologic DMARDs. Two GLM treatment strategies (subcutaneous [SC] vs intravenous [IV]/SC combination) for induction and maintenance of remission were evaluated.

Methods: GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ≥3.2). In Part I, patients received 50-mg SC GLM once monthly for 6 months. The primary outcome was the percentage of patients with good or moderate EULAR DAS28-ESR response at 6 months. Effects of several variables on response were evaluated: MTX dosage, type of concomitant DMARDs, corticosteroid (CS) use, and number of failed DMARDs. In Part II, patients who achieved good or moderate response but not remission at 6 months were eligible for random assignment to treatment up to month 12 with either continued 50-mg SC GLM once monthly or a combination of IV GLM and SC GLM. The coprimary efficacy endpoints in Part II were the percentage of patients with EULAR DAS28-ESR remission at the beginning of month 11 and the end of month 12. Treatment effects were evaluated with chi-square tests.

Results: At baseline of Part I, 3280 efficacy-evaluable patients had mean age 52.3 (SD=12.8) years, median disease duration 4.9 years, mean HAQ-DI 1.44 (SD= 0.67), and mean DAS28-ESR 5.97 (SD=1.10). Concomitant MTX was used by 81.1% of patients; concomitant CSs by 63.4% of patients. 34.4%, 35.9%, and 29.7% of patients failed 1, 2, and 3 DMARDs, respectively. At month 6, 82.07% (2692/3280) of patients achieved a good or moderate EULAR DAS28-ESR response and 23.90% (784/3280) achieved remission. No statistically or clinically significant differences were seen when treatment response was compared for patients who received concomitant MTX or CS vs those who did not, for high- vs low-dose MTX, or for patients who failed multiple vs only 1 DMARD. In Part II, 490 responders who were not in remission were evaluable for efficacy. The 2 treatment arms had similar DAS28-ESR remission rates at the month-11 and -12 endpoints (ranging from 24% to 27%) and were similar in the time to first remission. GLM was generally well tolerated. Observed SAEs were consistent with those observed in RA patients treated with anti-TNF agents. In Part 1, SAEs occurred in 5.7% of patients and 10 deaths (0.2%) occurred. In Part II, SAEs occurred in 6.9% and 2.4% of patients in the IV/SC and SC arms, respectively, and 1 death occurred in the IV/SC arm.

Conclusion: In patients with active RA despite DMARD therapy, addition of GLM 50-mg once monthly resulted in moderate or good EULAR DAS28 response at 6 months for 82.07% of patients. Response to GLM was not impacted by use of concomitant MTX or CS, dose of concomitant MTX, or number of failed DMARDs. Of patients with response but not remission at month 6, approximately 25% achieved remission after 6 additional months of GLM treatment. The IV/SC regimen provided no additional efficacy over the SC regimen and was associated with a higher incidence of AEs. The safety profile for the SC regimen was consistent with previous studies of GLM.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-golimumab-as-add-on-therapy-to-disease-modifying-antirheumatic-drugs/