FRI0102 SERUM TNFΑ LEVELS AT 24 HOURS AFTER FIRST ADMINISTRATION OF CERTOLIZUMAB PEGOL PREDICT EFFECTIVENESS AT WEEK 12 IN PATIENTS WITH RHEUMATOID ARTHRITIS FROM TSUBAME STUDY (UMIN ID:0002381)

Background: To increase the remission rate of rheumatoid arthritis (RA), it is necessary to determine the efficacy of the tumor necrosis factor (TNF) inhibitor as early as possible. Moreover, the response to certolizumab pegol (CZP) at 12 weeks has been reported to predict its long-term efficacy. Objectives: As part of a prospective single-center observational study (TSUBAME study), we prospectively enrolled patients to be treated with CZP in our institution to evaluate its effectiveness and safety starting at 24 hours after the first dose in clinical settings, while recording blood CZP concentrations and biomarkers over time to examine their correlation with clinical effects. Methods: One hundred patients with RA and inadequate response to MTX who received CZP were enrolled in the TSUBAME study. The changes in serum TNFα, IL-6, and CZP levels at 24 hours after first administration of CZP were measured, and the correlation between serum biomarkers and clinical response was determined. Results: At 24 hours after CZP initiation, significant improvement was observed in the disease activity (baseline and 24 h: 5.4 ± 1.3, 5.0 ± 1.3, respectively, p Conclusion: CZP was effective where serum TNFα was strongly neutralized within 24 hours. These results suggest that low serum TNFα levels at 24 hours after first administration of CZP may predict the effectiveness of CZP. To increase the remission rate in RA, it is necessary to determine the effectiveness of the molecular targeted drugs used at an early point, in addition to how rapid the onset of action is. CZP is extremely fast-acting, and its effectiveness can be predicted as early as 24 hours after the first dose, suggesting that it may be possible to determine the effectiveness early. Acknowledgments: The authors thank Ms. M. Hirahara for providing excellent technical assistance. Disclosure of Interests: Yusuke Miyazaki Grant/research support from: Astellas Pharma Inc and UCB S.A., Kazuhisa Nakano: None declared, Shingo Nakayamada Grant/research support from: Mitsubishi-Tanabe, Takeda, Novartis and MSD, Speakers bureau: Bristol-Myers, Sanofi, Abbvie, Eisai, Eli Lilly, Chugai, Asahi-kasei and Pfizer, Satoshi Kubo: None declared, Shigeru Iwata: None declared, Kentaro Hanami: None declared, Shunsuke Fukuyo: None declared, Ippei Miyagawa: None declared, Ayako Yamaguchi: None declared, Akio Kawabe: None declared, SAITO KAZUYOSHI: None declared, Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin