The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
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Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis

  • Kang, Young Mo (Division of Rheumatology, Department of Internal Medicine, School of Medicine, Kyungpook National University) ;
  • Park, Young-Eun (Division of Rheumatology, Department of Internal Medicine, Pusan National University Hospital) ;
  • Park, Won (Division of Rheumatology, Department of Internal Medicine, Inha University Hospital) ;
  • Choe, Jung-Yoon (Department of Internal Medicine, Daegu Catholic University Medical Center) ;
  • Cho, Chul-Soo (Division of Rheumatology, Department of Internal Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea) ;
  • Shim, Seung-Cheol (Division of Rheumatology, Department of Internal Medicine, Chungnam National University Hospital) ;
  • Bae, Sang Cheol (Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases) ;
  • Suh, Chang-Hee (Division of Rheumatology, Department of Internal Medicine, Ajou University Hospital) ;
  • Cha, Hoon-Suk (Division of Rheumatology, Department of Internal Medicine, Sungkyunkwan University School of Medicine) ;
  • Koh, Eun Mi (Division of Rheumatology, Department of Internal Medicine, Sungkyunkwan University School of Medicine) ;
  • Song, Yeong-Wook (Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital) ;
  • Yoo, Bin (Division of Rheumatology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Lee, Shin-Seok (Division of Rheumatology, Department of Internal Medicine, Chonnam National University Hospital) ;
  • Park, Min-Chan (Division of Rheumatology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine) ;
  • Lee, Sang-Heon (Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center) ;
  • Arendt, Catherine (UCB Pharma) ;
  • Koetse, Willem (UCB Pharma) ;
  • Lee, Soo-Kon (Division of Rheumatology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine)
  • Received : 2016.07.01
  • Accepted : 2016.10.26
  • Published : 2018.11.01
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Abstract

Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ${\geq}1.2$ (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

Keywords

References

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