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SAT0178 Predictors of Effectiveness in Golimumab Treatment and Efficacy of Dose-Escalation of Golimumab in Patients with Rheumatoid Arthritis – A Multicenter Registry Study TBCR
  1. Y. Hirano1,
  2. M. Hayashi2,
  3. S. Hirabara1,
  4. N. Takahashi3,
  5. Y. Kanayama4,
  6. A. Kaneko5,
  7. T. Kojima3,
  8. N. Ishiguro3
  9. on behalf of Tsurumai Biologics Communication Registry (TBCR)
  1. 1Rheumatology, Toyohashi Municipal Hospital, Toyohashi
  2. 2Orthopaedic Surgery, Nagano Red Cross Hospital, Nagano
  3. 3Orthopaedic Surgery and Rheumatology, Nagoya University School of Medicine, Nagoya
  4. 4Rheumatology, Toyota Kosei Hospital, Toyota
  5. 5Orthopaedic Surgery and Rheumatology, Nagoya Medical Center, Nagoya, Japan

Abstract

Background Golimumab (GLM) is a human anti-tumor necrosis factor (TNF) alpha monoclonal antibody and shown to be effective in the treatment of rheumatoid arthritis (RA). Although early prediction of the efficacy of GLM is important for early modification of treatment, the information is lacking. Although one of the modifications in the GLM treatment is dose-escalation of GLM from 50mg to 100mg every 4 week, the information of dose-escalation is also lacking in the clinical setting.

Objectives This retrospective observational study investigated (1) the efficacy and the drug retention rate of GLM in Japanese clinical setting, (2) the predictors of efficacy of GLM treatment and (3) the efficacy of dose-escalation of GLM due to lack of efficacy using the multicenter registry data in Japan (Tsurumai Biologics Communication registry: TBCR).

Methods 111 RA patients treated with GLM were used in this study. Patients' characteristics, time course of disease activity and drug retention rate using Kaplan-Meier method were investigated. Good outcome group (GOgroup: DAS28-CRP<2.6 at 52 weeks) and not-good outcome group (NGOgroup) were compared with each other with respect to baseline characteristics, baseline disease activity and disease activity at 4 weeks. The dose-escalation cases (n=14) were compared with the cases treated with GLM 50mg (n=25) with respect to patients' characteristics and the efficacy of dose-escalation was also evaluated.

Results 93 female and 18 male were included. Mean age was 61.9 years old. Mean RA duration was 158.4 months. MTX usage was 73.0%. PSL usage was 54.3%. Bio-naive was 53.2%. Mean DAS28-CRP and mean SDAI at 0w-4w-12w-24w-52w were 3.99-3.24-2.92-2.81-2.72 and 20.6-14.0-11.0-10.2-9.5, respectively. Both DAS28-CRP and SDAI were significantly decreased after 4 week. Drug retention rate of GLM was 79.2% at 1 year and 77.1% at 2 year. Reasons for stopping GLM were lack of efficacy in 6 cases, adverse event in 5 cases and others in 4 cases. Age, MMP-3 at 0w, TJC at 4w, ESR at 4w, MMP-3 at 4w, DAS28-CRP at 4w and SDAI at 4w in GOgroup were significantly low compared with those in NGOgroup. AUC of MMP-3 at 0w, TJC at 4w and DAS28-CRP at 4w were over 0.7 using ROC analysis and cut-off values were 133.3ng/ml, 3 and 3.09, respectively. MMP-3 at initiation of GLM treatment in the dose-escalation cases was significantly high compared with that in GLM50mg cases (253.5 vs. 9.8, p=0.043). Cut-off value of MMP-3 at 0w for prediction of dose-escalation was 99.7ng/ml using ROC analysis (AUC=0.714). DAS28-CRP and CRP were improved after dose escalation of GLM in dose-escalation cases.

Conclusions GLM was effective in RA patients in Japanese clinical setting. Effectiveness at 52w could be predicted using baseline characteristics and early response in GLM treatment. Serum MMP-3 was one of the predictors for effectiveness at 52w and dose-escalation. In conclusion, RA patients with high MMP-3 and RA patients without good early response at 4 week may be necessary to be treated with GLM 100mg in the early time of GLM treatment.

Disclosure of Interest Y. Hirano Speakers bureau: Abbott Japan Co. Ltd.; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Corporation; Pfizer Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; and Bristol-Myers Squibb Co. Ltd., M. Hayashi: None declared, S. Hirabara: None declared, N. Takahashi Speakers bureau: Abbott Japan Co. Ltd.; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Corporation; Pfizer Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; and Bristol-Myers Squibb Co. Ltd., Y. Kanayama: None declared, A. Kaneko Speakers bureau: Abbott Japan Co. Ltd.; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Corporation; Pfizer Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; and Bristol-Myers Squibb Co. Ltd., T. Kojima Speakers bureau: Abbott Japan Co. Ltd.; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Corporation; Pfizer Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; and Bristol-Myers Squibb Co. Ltd., N. Ishiguro Speakers bureau: Abbott Japan Co. Ltd.; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Corporation; Pfizer Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; and Bristol-Myers Squibb Co. Ltd.

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