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 This study aimed to provide clinical evidence of an adequate observational period for predicting remission and low disease activity (LDA) achievement at 52 weeks in RA patients treated with Certolizumab pegol (CZP).
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 2015 were enrolled.The final study cohort of 98 Japanese RA patients. We reviewed the methods about the improvement of DAS28-ESR and SDAI which was an index of disease activity of RA using Wilcoxon signed-rank test and the rate of remission and LDA patients at Week4, 8, 12, 24 and 52 by LOCF method. Also we used ROC analysis in order to determine the optimal period to achieve remission for the DAS-ESR and SDAI at Week52.
Results The group of patients included 16 males and 82 females. The mean age was 59.5±14.7 years old; the disease duration was 9.4±8.8 years; the patients of receiving methotrexate (MTX) was 73 cases (74%); the MTX dose was 11.2±3.6 mg/week and b-DMARD naïve patients was 57 cases (61%). Clinical findings related to RA were as follows: mean tender joint count, 5.2±4.7; swollen joint count, 5.0±4.0; patient's and physician's global assessment of disease activity, 48.9±27.4 and 42.3±23.2mm; CRP, 1.9±2.2 mg/dL; ESR, 47.4±34.0 mm/h; MMP3, 233±186 ng/ml; the rate of rheumatoid factor positive patients was 78%; DAS28 (ESR), 4.84±1.36; and SDAI, 21.2±11.3. The mean DAS-ESR improved to 3.54±1.35, 3.31±1.46, 3.37±1.47 and 3.31±1.43 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 11.4±9.0, 9.7±9.0, 9.8±9.1 and 9.4±9.1 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 28.8, 37.2, 32.9, 33.7% and 11.7, 29.3, 30.5, 28.8% 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 46.6, 53.2, 51.2, 55.8% and 58.8, 64.1, 65.9, 71.3% in DAS-ESR and SDAI criteria. Areas under the receiver operating characteristic curves for the DAS28-ESR and SDAI at each time point for remision achievement at 52 weeks were each 0.578 and 0.702 at baseline, 0.755 and 0.822 at week4, 0.821 (cut-off index 2.73, odds ratio 16.7, sensitivity 0.75, specificity, 0.85) and 0.856 (cut-off index 5.30, odds ratio 29.6, sensitivity 0.86, specificity, 0.82) at week8, and 0.820 and 0.809 at week12.
Conclusions The new TNF-antagonist therapy of CZP was effective early and rapidly in patients with active Japanese RA. This study suggested that eight weeks is an adequate optimal period to judge whether the achieved remission or not at Week 52.
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, T. Kato: None declared, M. Hayashi: None declared, 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, 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