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THU0199 Week 12 Clinical Response to Certolizumab Pegol Predicts Long-Term Outcomes Regardless of Concomitant Medications and Baseline Disease Characteristics in Japanese Patients with Active Rheumatoid Arthritis
  1. H. Yamanaka1,
  2. K. Yamamoto2,
  3. T. Takeuchi3,
  4. N. Ishiguro4,
  5. Y. Tanaka5,
  6. K. Eguchi6,
  7. A. Watanabe7,
  8. H. Origasa8,
  9. T. Shoji9,
  10. S. Onodera9,
  11. N. Miyasaka10,
  12. T. Koike11
  1. 1Tokyo Women’s Medical University
  2. 2University of Tokyo
  3. 3Keio University, Tokyo
  4. 4Nagoya University, Nagoya
  5. 5University of Occupational and Environmental Health, Kitakyushu
  6. 6Sasebo City General Hospital, Nagasaki
  7. 7Tohoku University, Sendai
  8. 8University of Toyama, Toyama
  9. 9UCB Pharma
  10. 10Tokyo Medical and Dental University, Tokyo
  11. 11NTT Sapporo Medical Center, Sapporo, Japan


Background Early response to certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, has been shown to predict long-term probability of low disease activity and inhibition of progression of structural joint damage in patients (pts) with active rheumatoid arthritis (RA) from the RAPID 1 trial.1

Objectives To examine whether clinical response to CZP at Week (Wk)12 predicts long-term clinical remission and inhibition of progression of structural damage in Japanese pts with active RA. To explore the impact of concomitant DMARDs and baseline (BL) disease status.

Methods 198 pts (J-RAPID [NCT00791999]2 82 pts; HIKARI [NCT00791921]3 116 pts) treated with CZP 200 mg every 2 wks were sub-grouped by concomitant medications and BL CRP (>1.8 vs ≤1.8 mg/L), DAS28 (>6.11 vs ≤6.11), and disease duration (>5 yrs vs ≤5 yrs). Remission rates and radiographic changes at Wk52 were compared to DAS28 responses obtained at Wk12. Pts in J-RAPID received concomitant MTX. Pts in HIKARI received DMARDs other than MTX or no concomitant DMARDs (“monotherapy”). Missing DAS28 data was imputed by last observation carried forward. Linear extrapolation was used to estimate the missing mTSS data at Wk52.

Results In pts with a DAS28 change ≥1.2 at Wk12 (Responders, R), DAS28 remission was achieved at Wk52 in 41.3% of J-RAPID and 34.9% of HIKARI pts (Table). In comparison, pts with a DAS28 response of <1.2 at Wk12 (Non-responders, NR) only had 5.3% and 6.7% chance of achieving remission, respectively, and had higher rates of radiographic progression at Wk52. Similar results were obtained in pts treated with CZP + non-MTX DMARDs and with CZP monotherapy. This lower probability of remission at Wk52 in NR at Wk12 was consistently observed regardless of BL CRP, DAS28 and disease duration in both studies.

Conclusions These analyses suggest that DAS28 response at Wk12 predicts long-term clinical and structural outcomes regardless of concomitant medication or BL disease status in Japanese pts treated with CZP.


  1. Keystone E. J Rheumatol 2011;38:6

  2. Yamamoto K. Arthritis Rheum 2011;63(Suppl10):S474

  3. Yamamoto K. Arthritis Rheum 2011;63(Suppl10):S476

Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma.

Disclosure of Interest H. Yamanaka Grant/research support from: Abbott, Astellas, BMS, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, UCB Pharma, Consultant for: Abbott, Astellas, BMS, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, UCB Pharma, K. Yamamoto Grant/research support from: Pfizer, Abbott, Santen, Mitsubishi-Tanabe, Eisai, UCB Pharma, Consultant for: Pfizer, Abbott, BMS, Roche, Chugai, Mitsubishi-Tanabe, Eisai, UCB Pharma, T. Takeuchi Grant/research support from: Abbott, Astellas, BMS, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe, Nippon Shinyaku, Otsuka, Pfizer, Sanofi-Aventis, Santen, Takeda, Teijin, Consultant for: AstraZeneca, Eli Lilly, Novartis, Mitsubishi-Tanabe, Asahi Kasei, Speakers bureau: Abbott, BMS, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, N. Ishiguro Grant/research support from: Takeda, Mitsubishi-Tanabe, Astellas, Chugai, Abbott, BMS, Eisai, Janssen, Kaken, Pfizer, Speakers bureau: Takeda, Mitsubishi-Tanabe, Astellas, Chugai, Abbott, BMS, Eisai, Janssen, Kaken, Pfizer, Taisho-Toyama, Otsuka, Y. Tanaka Grant/research support from: BMS, MSD, Chugai, Mitsubishi-Tanabe, Astellas, Abbott, Eisai, Janssen, Speakers bureau: Mitsubishi-Tanabe, Abbott, Eisai, Chugai, Janssen, Santen, Pfizer, Astellas, Daiichi-Sankyo, GSK, AstraZeneca, Otsuka, Actelion, Eli Lilly, Nippon Kayaku, Quintiles Transnational, Ono, UCB Pharma, K. Eguchi Consultant for: UCB Pharma, A. Watanabe Grant/research support from: Astellas, Daiichi-Sankyo, Kyorin, Shionogi, Taisho, Dainippon-Sumitomo, Taiho, Toyama Chemical, Meiji Seika, Speakers bureau: Abbott, MSD, Otsuka, GSK, Shionogi, Daiichi-Sankyo, Taisho-Toyama, Dainippon-Sumitomo, Mitsubishi-Tanabe, Toyama Chemical, Bayer, Pfizer, H. Origasa Consultant for: Astellas, UCB Pharma, T. Shoji Employee of: UCB Pharma, S. Onodera Employee of: UCB Pharma, N. Miyasaka Grant/research support from: Pfizer, Takeda, Mitsubishi-Tanabe, Chugai, Abbott, Eisai, Astellas, T. Koike Speakers bureau: Pfizer, Chugai, Abbott, Mitsubishi-Tanabe, Takeda, Eisai, Santen, Astellas, Taisho-Toyama, BMS, Teijin, Daiichi-Sankyo, UCB Pharma

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