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SAT0375 Certolizumab Pegol for The Treatment of Axial Spondyloarthritis: 4-Year Outcomes from The Rapid-AXSPA Trial
  1. D. van der Heijde1,
  2. M. Dougados2,
  3. R. Landewé3,
  4. J. Sieper4,
  5. W.P. Maksymowych5,
  6. M. Rudwaleit6,
  7. F. van den Bosch7,
  8. J. Braun8,
  9. P.J. Mease9,
  10. O. Davies10,
  11. B. Hoepken11,
  12. L. Peterson12,
  13. A. Deodhar13
  1. 1Department of Rheumatology, Leiden University Medical Centre, Leiden, Netherlands
  2. 2Department of Rheumatology, Cochin Hospital, Paris, France
  3. 3Academic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, Netherlands
  4. 4Rheumatology Department, University Hospital Charité, Berlin, Germany
  5. 5Department of Medicine, University of Alberta, Edmonton, Canada
  6. 6Department of Internal Medicine and Rheumatology, Klinikum Bielefeld, Bielefeld, Germany
  7. 7Ghent University Hospital, Ghent, Belgium
  8. 8Rheumazentrum Ruhrgebiet, Herne, Germany
  9. 9Swedish Medical Center and University of Washington, Seattle, United States
  10. 10UCB Pharma, Slough, United Kingdom
  11. 11UCB Pharma, Monheim, Germany
  12. 12UCB Pharma, Raleigh
  13. 13Oregon Health & Science University, Portland, United States

Abstract

Background The RAPID-axSpA trial (NCT01087762) investigated the efficacy and safety of certolizumab pegol (CZP) for the treatment of patients (pts) with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS; also termed radiographic-axSpA) and non-radiographic (nr)-axSpA pts. Previous reports have shown CZP to be safe and efficacious over 96 weeks (wks) of treatment.1

Objectives To report 4-year efficacy and safety data from the RAPID-axSpA trial.

Methods RAPID-axSpA was double-blind and placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label (OL) to Wk204. Pts fulfilled ASAS criteria and had active axSpA with positive sacroiliac joint MRI and/or raised CRP (>7.9mg/L). Pts originally randomized to CZP (200mg Q2W or 400mg Q4W) continued on their assigned dose in the OL period. Outcomes assessed included: ASAS responses, ASDAS, BASDAI, BASFI, BASMI-linear and enthesitis. Efficacy data are presented for pts originally randomized to CZP (combined doses) as observed case and with imputation: NRI for categorical and LOCF for continuous measures. The safety set consisted of all pts treated with ≥1 dose of CZP to Wk204.

Results 325 pts were randomized, of whom 218 received CZP from Wk0. Of CZP-randomized pts, 93% completed to Wk24, 88% to Wk48 and 65% to Week 204 (AS: 67%; nr-axSpA: 63%). In the OL period, 9.2% of pts withdrew due to an adverse event (AE) and 1.4% due to lack of efficacy.

The proportion of pts achieving ASAS20/40 and partial remission (PR) responses at Wk24 was maintained over 4 years (to Wk204) in pts remaining in the study (Table). Efficacy, expressed as ASDAS ID rates (LOCF: Wk24: 30.3%; Wk204: 32.1%), mean ASDAS score (baseline: 3.84; LOCF: Wk24: 2.07; Wk204: 1.98), and all other outcomes reported, was maintained to Wk204. Similar improvements were seen in AS and nr-axSpA pts (Figure/Table) and in both CZP dose regimens (data not shown). Function (BASFI) was also improved in both subpopulations, with nr-axSpA pts having a particularly low mean score by Wk204 (Table).

Pts in the safety set (N=315) had a total CZP exposure of 981 patient-years (PY), with an AE rate (ER) per 100 PY of 292.9. No new safety signals were identified from Wk96 to Wk204, and no deaths were reported over 4 years.

Conclusions CZP efficacy was maintained in axSpA pts over 4 years with no new safety signals. Treatment responses to CZP were similar in AS and nr-axSpA pts.

  1. Sieper J. Arthritis Rheum 2015;67:668–77

Acknowledgement The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance.

Disclosure of Interest D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB Pharma, Employee of: Director of Imaging Rheumatology bv, M. Dougados Grant/research support from: UCB Pharma, Abbvie, Pfizer, Lilly, Merck and Novartis, Consultant for: UCB Pharma, Abbvie, Pfizer, Lilly, Merck and Novartis, R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, Consultant for: Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Centocor, Glaxo-Smith-Kline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, Speakers bureau: Abbott, Amgen, Bristol Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, J. Sieper Consultant for: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly and Janssen, Speakers bureau: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly and Janssen, W. Maksymowych Grant/research support from: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma, Consultant for: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma, Speakers bureau: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma, M. Rudwaleit Consultant for: Abbott, BMS, Janssen, MSD, Pfizer, Roche and UCB Pharma, F. van den Bosch Consultant for: Abbvie, Bristol Myers-Squibb, Celgene, Janssen, Merck, Novartis, Pfizer, UCB Pharma, Speakers bureau: Abbvie, Bristol Myers-Squibb, Celgene, Janssen, Merck, Novartis, Pfizer, UCB Pharma, J. Braun Grant/research support from: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma, Consultant for: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma, P. Mease Grant/research support from: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant for: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Pfizer and UCB Pharma, O. Davies Shareholder of: UCB Pharma, Employee of: UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, A. Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Consultant for: AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB Pharma

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