Date: Sunday, October 21, 2018
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Certolizumab-pegol (CZP) is a sixth antitumor necrosis factor inhibitor for rheumatoid arthritis (RA) in Japan. Several clinical trials were conducted to evaluate the efficacy and safety of CZP, such as J-RAPID, HIKARI and C-OPERA study. They clarified the efficacy and safety of CZP for RA. However, the target population of most clinical trials is limited by the inclusion and exclusion criteria of the studies. Thus, the target populations are different between those in clinical trials and in daily practice. We investigated the effectiveness and safety of CZP for RA in daily practice.
Methods: Patients who started CZP after April 1, 2013 were investigated in this retrospective study. Retention rate, change in disease activity and safety of CZP obtained through medical records and the data from Institute of Rheumatology, Rheumatoid Arthritis (IORRA) cohort were analyzed. The missing data were complemented by using the last-observation-carried-forward (LOCF) method. Effectiveness was assessed by 28-joint Disease activity score (DAS28) and the factors associated with therapeutic response at 12 weeks with CZP by using logistic regression analysis. Retention rate was assessed by Kaplan-Meier method. Patients were followed until August 31, 2017.
Results: Consecutive 143 RA patients who started CZP at our institute were enrolled. Women were 93%. The median (interquartile range) age was 48 (36-59). Disease duration was 7 (3-14) years, and treatment periods were 39 (15-100) weeks. DAS28 was 3.7 (2.8-4.3) at baseline. Bio-naive patients were 42%. Methotrexate (MTX) was used in 68% and the median dose was 10 (8-12) mg/week. Prednisolone was used in 39% and the median dose was 5 (4.0-8.8) mg/day at baseline. Patients who wanted to be pregnant were 42 (31% among women). The number of patients who could not continue CZP was 89 (62%), due to lack of effectiveness 51, marked effectiveness 2, pregnancy 5 and side effects 13. The DAS28 at 12 weeks was decreased from 3.6 to 2.9 (p<0.01). The DAS28 at 12 weeks was more decreased in bio-naïve subset than bio-switch subset significantly (p<0.01) and same tendency was detected in patients with MTX subset than without MTX (p<0.01). Bio- naïve might be the factor for achieving good response at 12 weeks (χ2 2.2, p=0.08). The retention rate was 80% at 12 weeks and 47% at 52 weeks. A greater percentage of patients in bio-naïve subset adhered to CZP than that of patients in bio-switch subset (p=0.04). Similarly, the retention rate of CZP with MTX subset was significantly higher than that without MTX subset (p=0.03).
Conclusion: Patients who wanted to be pregnant was over 30% among women who used CZP. CZP was more effective in patients with bio-naïve and patients treated with CZP concomitant with MTX. The fact that seen in trial was ascertained in daily practice.
To cite this abstract in AMA style:Sugitani N, Tanaka E, Inoue E, Sugano E, Saka K, Ochiai M, Yamaguchi R, Shimizu Y, Sugimoto N, Ikari K, Nakajima A, Taniguchi A, Yamanaka H. Real-World Experience of Effectiveness and Safety of Certolizumab Pegol for Rheumatoid Arthritis in Japan: Single-Center Retrospective Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/real-world-experience-of-effectiveness-and-safety-of-certolizumab-pegol-for-rheumatoid-arthritis-in-japan-single-center-retrospective-study/. Accessed October 22, 2020.
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