Safety and effectiveness of certolizumab pegol in patients with rheumatoid arthritis: Interim analysis of post-marketing surveillance

Hideto Kameda, Keiichiro Nishida, Toshihiro Nannki, Akira Watanabe, Yukiya Oshima, Shigaki Momohara

    Research output: Contribution to journalArticle

    2 Citations (Scopus)

    Abstract

    Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. Methods: Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. Results: The total period of exposure to CZP was 1313.8 patient-years (PY). AEs were reported in 658 (25.5%) patients, at an event rate (ER) of 73.68/100 PY. The most frequent serious AEs were pneumonia, herpes zoster, and interstitial lung disease, at ER per 100 PY of 2.06, 1.29, and 1.22, respectively. Mean disease activity scores at baseline, as measured by DAS28-ESR and DAS28-CRP, were 4.77 ± 1.34 and 4.21 ± 1.27, respectively. Mean changes from baseline at the last observation were –1.29 ± 1.46 and –1.30 ± 1.42, respectively. EULAR good or moderate responses were achieved in 65% of patients. Longer disease duration, prior biologics use, and treatment without MTX co-therapy were associated with EULAR no response. Conclusion: In this interim analysis, no new safety signals were observed. Clinical response to CZP was observed in approximately two thirds of patients.

    Original languageEnglish
    Pages (from-to)196-205
    Number of pages10
    JournalJapanese Journal of Clinical Immunology
    Volume40
    Issue number3
    DOIs
    Publication statusPublished - 2017

    Keywords

    • Certolizumab pegol
    • Effectiveness
    • Post-marketing surveillance
    • Rheumatoid arthritis
    • Safety

    ASJC Scopus subject areas

    • Immunology and Allergy
    • Immunology

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