Background Golimumab (GLM), a human anti-TNF monoclonal antibody that binds with high affinity and specificity to soluble and transmembrane TNF antagonizes the effects of TNF. GLM plus methotrexate (MTX) has demonstrated statistically significant efficacy versus MTX monotherapy in MTX-naïve patients (pts) with RA and in pts with active RA despite prior MTX therapy. A phase 2/3 study was conducted to examine the efficacy and safety of GLM plus MTX in Japanese pts with active RA despite MTX therapy (GO-FORTH).
Objectives To assess long-term efficacy and safety of GLM in Japanese pts with active RA despite MTX therapy.
Methods GO-FORTH is a multicenter, randomized, double-blind, placebo (PBO)-controlled study in pts with active RA despite MTX. Pts were randomized to SC PBO, GLM50 mg or GLM100 mg q4 wks. All pts received MTX 6-8 mg orally/wk. Primary endpoint was the proportion of pts achieving ACR20 at wk 14 of double blind phase. After wk 24, pts who randomized to PBO crossed over to GLM50 mg. Treatment with GLM continued to wk 156 at longest. RA remission rates were retrospectively assessed using the new ACR/EULAR remission criteria (SDAI and Boolean) through wk 104. Data were analyzed using the all pts receiving ≥1 dose of study treatment.
Results Proportion of patients who continued treatment at wk 104 was 79.5% in PBO→GLM50 mg, 77.9% in GLM 50 mg and 81.6% in GLM 100 mg, respectively. Clinical remission defined as DAS28 (ESR) <2.6 and HAQ remission defined as HAQ <0.5 were maintained between wk 52 and wk 104. At wk 104, the SDAI and Boolean remission rates were 44.8% and 31.3% in GLM 50 mg group and 39.4% and 29.6% in GLM 100 mg group, respectively. Both dose groups were comparable. Median changes from baseline to wk 52 or wk 104 in TSS were zero in all of the treatment groups. The proportions of pts with changes in TSS greater than the smallest detectable change (SDC) and no progression (change in TSS≤0) were also maintained from wk 52 to wk 104. Incidences of SAEs and serious infection were similar between GLM 50 mg and 100 mg.
Conclusions Treatment with GLM50 mg and 100 mg plus MTX sustained the efficacy of signs/symptoms and prevention of structural damage during wk 104. The GLM plus MTX safety profile was similar to other anti-TNF agents.
Disclosure of Interest: Y. Tanaka Grant/research support from: Janssen R&D, LLC, M. Harigai Grant/research support from: Janssen R&D, LLC, T. Takeuchi Grant/research support from: Janssen R&D, LLC, H. Yamanaka Grant/research support from: Janssen R&D, LLC, N. Ishiguro Grant/research support from: Janssen R&D, LLC, K. Yamamoto Grant/research support from: Janssen R&D, LLC, Y. Murakami Employee of: Janssen Pharmaceutical KK, T. Yoshinari Employee of: Mitsubishi Tanabe Pharma Corporation, D. Baker Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, N. Miyasaka Grant/research support from: Janssen R&D, LLC, T. Koike Grant/research support from: Janssen R&D, LLC
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