Background Golimumab (GLM) is a monoclonal antibody that binds with high affinity and specificity to 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. Some patients cannot tolerate MTX treatment. Therefore, it is clinically relevant to evaluate the safety and efficacy of GLM monotherapy in pts with active RA who were previously treated with disease-modifying anti-rheumatic drugs (DMARDs).
Objectives To assess the long-term efficacy and safety of GLM as monotherapy in Japanese pts with active RA despite DMARD therapy.
Methods GO-MONO is a multicenter, randomized, double-blind, placebo (PBO)-controlled study in Japanese pts with active RA despite treatment with DMARDs. Pts were randomized to SC PBO, GLM50 mg or GLM100 mg q4 wks as monotherapy. At wk 16, pts in the PBO group crossed over to GLM50 mg q4 wks. Treatment with GLM continued to wk 120. Primary endpoint was the proportion of pts achieving ACR20 at wk 14.
Results Proportion of patients who continued treatment at wk 104 was 71.4% in PBO→GLM50 mg, 72.3% in GLM 50 mg and 88.2% 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 31.1% and 24.3% in GLM 50 mg group and 27.8% and 23.3% in GLM 100 mg group, respectively. Median changes in TSS from baseline to wk 104 in PBO→GLM50 mg, GLM50 mg and 100 mg were 1.5, 1.25 and 1.0, respectively. The proportions of pts with changes in TSS greater than the smallest detectable change (SDC) were also maintained from wk 52 and wk 104. Proportion of pts with no progression (change in TSS≤0) were slightly decreased from wk 52 to wk 104 in both of GLM50 mg and 100 mg. Incidences of SAEs and AEs leading to discontinuation in GLM50 mg were higher than 100 mg.
Conclusions Treatment with GLM50 mg and 100 mg monotherapy sustained the efficacy of signs/symptoms during wk 104. Inhibition of structural damage in GLM100 mg was relatively greater than GLM50 mg; however, the progression was slow during wk 104 in both of the GLM groups. The GLM safety profile was similar to other anti-TNF agents.
References Takeuchi T. et al, Ann Rheum Dis 2012;0:1-8
Disclosure of Interest T. Takeuchi Grant/research support from: Janssen R&D, LLC, M. Harigai Grant/research support from: Janssen R&D, LLC, Y. Tanaka 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 Corp, 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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