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OP0106 Effect of Certolizumab Pegol on Signs and Symptoms of Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis: 24-Week Results of Rapid-Axspa Study
  1. R. Landewé1,
  2. M. Rudwaleit2,
  3. D. van der Heijde3,
  4. M. Dougados4,
  5. W. P. Maksymowych5,
  6. J. Braun6,
  7. A. Deodhar7,
  8. C. Stach8,
  9. B. Hoepken8,
  10. G. Coteur9,
  11. D. Kielar9,
  12. A. Fichtner8,
  13. T. Arledge10,
  14. J. Sieper11
  1. 1Department of Internal Medicine/Rheumatology, Academic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, Netherlands
  2. 2Endokrinologikum, Berlin, Germany
  3. 3Department of Rheumatology, Leiden University Medical Centre, Leiden, Netherlands
  4. 4Department of Rheumatology, Cochin Hospital, Paris, France
  5. 5Department of Medicine, University of Alberta, Edmonton, Canada
  6. 6Rheumazentrum Ruhrgebiet, Herne, Germany
  7. 7Oregon Health & Science University, Portland, United States
  8. 8UCB Pharma, Monheim, Germany
  9. 9UCB Pharma, Brussels, Belgium
  10. 10UCB Pharma, Raleigh, United States
  11. 11Rheumatology Department, University Hospital Charité, Berlin, Germany

Abstract

Background Axial spondyloarthritis (axSpA) includes both ankylosing spondylitis (AS) and axSpA with no definitive sacroiliitis on X-ray (non-radiographic axSpA, nr-axSpA). RAPID-axSpA (NCT01087762) is the first RCT of an anti-TNF to include both populations.

Objectives To report the 24-week (wk) efficacy and assess safety of certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, in axSpA.

Methods The ongoing 158-wk RAPID-axSpA trial was double-blind and placebo (PBO)-controlled to Wk24.1 Recruited pts had adult-onset active axSpA according to the ASAS criteria,2 and included AS pts also meeting the modified New York criteria and nr-axSpA pts. Pts were randomized 1:1:1 to PBO every 2 wks (Q2W), or 400mg CZP at Wk0, 2 and 4 (loading dose) followed by either 200mg CZP Q2W or 400mg CZP every 4 wks (Q4W). The primary endpoint was ASAS20 response at Wk12. Secondary endpoints included ASAS40 and ASAS partial remission responses, and change from baseline (BL) in BASDAI, BASFI, and BASMI linear. Other outcomes included ASDAS major improvement and inactive disease response rates. NRI was used for categorical measures; LOCF was used for continuous measures. Outcomes analyzed in the randomized pt set.

Results 325 pts were randomized. BL characteristics were similar between treatment groups. Disease activity was similar between AS and nr-axSpA pts. The primary endpoint, ASAS20 at Wk12, was achieved with clinically and statistically significant improvements in CZP 200mg Q2W and CZP 400mg Q4W arms vs PBO (57.7 and 63.6 vs 38.3, p≤0.004). Significant improvements in ASAS20 were observed as early as Wk1 (40.5 and 34.6 vs 14.0, p<0.001) and maintained at Wk24. Other response rates were also higher in the CZP arms vs PBO at Wk24 (Figure). At Wk24, combined CZP arms showed statistically significant (p<0.001) differences in change from BL vs PBO in BASDAI (-3.1 vs -1.1), BASFI (-2.3 vs -0.4), and BASMI (-0.5 vs -0.1). Similar improvements were reported with CZP vs PBO in both AS and nr-axSpA pts.1 Adverse events (AEs) occurred in 70.4% vs 62.6%, serious AEs in 4.7% vs 4.7%, and serious infections in 1.1% vs 0% of CZP (combined dose) pts vs PBO pts. No deaths or malignancies were reported.

Conclusions CZP rapidly reduced the signs and symptoms of axSpA, with no new safety signals observed. Similar improvements were observed across CZP dosing regimens, and in both AS and nr-axSpA pts.

References

  1. Landewé R. Arthritis Rheum 2012;64(10):336-337,

  2. Rudwaleit M. Ann Rheum Dis 2009;68(6):770-776

References

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

Disclosure of Interest R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Consultant for: Abbott, Ablynx, Amgen, AstraZeneca, BMS, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Speakers bureau: Abbott, Amgen, BMS, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, M. Rudwaleit Consultant for: Abbott, BMS, MSD, Pfizer, Roche, UCB Pharma, D. van der Heijde Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli Lilly, GSK, Janssen, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli Lilly, GSK, Janssen, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex, Employee of: Imaging Rheumatology bv, M. Dougados Grant/research support from: UCB Pharma, Consultant for: UCB Pharma, W. Maksymowych Grant/research support from: Abbott, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma, Consultant for: Abbott, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma, Speakers bureau: Abbott, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma, J. Braun Grant/research support from: Abbott, BMS, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, Consultant for: Abbott, BMS, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, A. Deodhar Grant/research support from: UCB Pharma, Abbott, Amgen, Janssen, Novartis, Consultant for: UCB Pharma, Abbott, Speakers bureau: Abbott, Novartis, C. Stach Shareholder of: UCB Pharma, Employee of: UCB Pharma, B. Hoepken Shareholder of: UCB Pharma, Employee of: UCB Pharma, G. Coteur: None Declared, D. Kielar Shareholder of: UCB Pharma, Employee of: UCB Pharma, A. Fichtner Employee of: UCB Pharma, T. Arledge Shareholder of: UCB Pharma, Employee of: UCB Pharma, J. Sieper Consultant for: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen, Speakers bureau: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen

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