Background Certolizumab pegol (CZP) is a polyethylene glycol (PEG)ylated Fc-free new anti-TNF α agent. However few data still reported clinical efficacy of CZP treatment in the routine practice.

Objectives To evaluate the clinical efficacy of CZP in patients with Japanese active RA for 52 weeks.

Methods Patients with a diagnosis of RA according to the 2010 ACR/EULAR criteria who had been prescribed CZP from Tsurumai Biologics Communication Registry (TBCR) between May 2013 and October 2014 were enrolled.The final study cohort of 80 RA patients. We reviewed the methods about the improvement of CRP, MMP3, DAS28-ESR and SDAI which was an index of disease activity of RA using Wilcoxon signed-rank, test and the rate of remission patients at Week4,8,12,24 and 52 by LOCF method.

Results The group of patients included 15 males and 65 females. The mean age was 60.1±14.2 years old; the disease duration was 9.7±9.3 years; the patients of receiving methotrexate (MTX) was 59 cases (74%); the MTX dose was 11.0±3.5 mg/week and b-DMARD naïve patients was 51 cases (64%). Clinical findings related to RA were as follows: mean tender joint count, 5.7±4.9; swollen joint count, 5.4±4.2; patient's and physician's global assessment of disease activity, 51.7±26.5 and 44.7±23.2mm; CRP, 1.9 ±2.2 mg/dL; ESR, 48.9±34.0 mm/h; MMP3, 224±172 ng/ml; the rate of rheumatoid factor positive patients was 77%; DAS28 (ESR), 5.01±1.31; and SDAI, 22.7±11.3. The mean CRP improved to 1.0±1.4, 0.8±1.3, 0.7±1.1 and 0.5± 1.0 at Week 4, 12, 24 and 52 (p<0.001, p<0.001, p<0.001, p<0.001), mean MMP3 improved to 153±132, 165±169, 119± 131 and 105±96 at Week 4, 12, 24 and 52 (p<0.001, p<0.001, p<0.001, p<0.001), the mean DAS-ESR improved to 3.70±1.35, 3.47±1.43, 3.47±1.46 and 3.41±1.45 at Week 4, 12, 24 and 52 (p<0.001, p<0.001, p<0.001, p<0.001) and the mean SDAI improved to 12.3±9.2, 10.6±9.1, 10.7±9.4 and 9.9±9.6 at Week 4, 12, 24 and 52 (p<0.001, p<0.001, p<0.001, p<0.001) significantly (Fig.1). At Week 4, 12, 24 and 52 the rate of patients who achieved remission were each 22.7, 28.9, 30.0, 31.3% and 7.4, 26.0, 30.2, 31.8% in DAS-ESR and SDAI criteria (Fig.2). Also at Week 4, 12, 24 and 52 the rate of patients who achieved low disease activity (LDA) were each 41.3, 47.3, 48.6, 55.2% and 55.9, 58.9, 60.4, 71.2% in DAS-ESR and SDAI criteria. We used logistic models in order to determine predictive factors to achieve remission and LDA at Week52. Even after adjusting for other risk factors, b-DMARD naïve and MTX combination remained significant and independent to achieve remission at Week52 (HR 3.88; 95%CI 0.95–15.89; p=0.059)(HR 4.06; 95%CI 0.79–20.88; p=0.094), and b-DMARD naïve and DAS-ESR at baseline remained significant and independent to achieve LDA at Week52 (HR 6.41; 95%CI 1.41–29.17; p=0.016)(HR 0.47; 95%CI 0.25–0.87; p=0.017) in the multivariate logistic analysis.

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Conclusions This study suggested that the new TNF-antagonist therapy of CZP was effective early and rapidly in patients with active Japanese RA. Especially lower DAS-ESR at baseline, MTX combination and b-DMARD naïve patients could expect higher efficacy of CZP treatment.

Disclosure of Interest Y. Kanayama: None declared, A. Kaneko Speakers bureau: Mitsubishi Tanabe Pharma, Takeda Pharma, Eisai Pharma, Chugai Pharma, Abbott, Bristol-Myers Squibb, UCB, Janssen, and Pfizer., N. Takahashi Speakers bureau: Abbvie Japan Co. Ltd, Eisai Co. Ltd, UCB Japan Co. Ltd, MitsubishiTanabe Pharma Corporation, Takeda Pharmaceutical Company Ltd, Pfizer Co. Ltd, Chugai Pharmaceutical Co. Ltd, Janssen Pharmaceutical K.K., and Bristol-Myers Squibb Co. Ltd., T. Kato: None declared, Y. Hirano Speakers bureau: Abbvie Japan, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Chugai Pharmaceutical, and Bristol-Myers Squibb., Y. Hattori: None declared, N. Asai: None declared, N. Ishiguro Grant/research support from: Daiichi Sankyo, Takeda Pharmaceutical, Hisamitsu Pharmaceutical, Otsuka Pharmaceutical, Taisho Toyama Pharmaceutical, Kaken Pharmaceutical, Eisai, Janssen Pharmaceutical, Bristol-Myers Squibb, AbbVie, Chugai Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Astellas Pharma, and Pfizer Japan, Speakers bureau: Daiichi Sankyo, Takeda Pharmaceutical, Hisamitsu Pharmaceutical, Otsuka Pharmaceutical, Taisho Toyama Pharmaceutical, Kaken Pharmaceutical, Eisai, Janssen Pharmaceutical, Bristol-Myers Squibb, AbbVie, Chugai Pharmaceutical, MitsubishiTanabe Pharmaceutical, Astellas Pharma, and Pfizer Japan., T. Kojima Speakers bureau: Mitsubishi Tanabe Pharma, Takeda Pharma, Eisai Pharma, AbbVie, Bristol-Myers Squibb, and Pfizer, Janssenn Pharmaceutical Companies, Astellas Pharma and Chugai Pharma.