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Extended report
Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study
  1. R Landewé1,
  2. J Braun2,
  3. A Deodhar3,
  4. M Dougados4,
  5. W P Maksymowych5,
  6. P J Mease6,
  7. J D Reveille7,
  8. M Rudwaleit8,
  9. D van der Heijde9,
  10. C Stach10,
  11. B Hoepken10,
  12. A Fichtner10,
  13. G Coteur11,
  14. M de Longueville11,
  15. J Sieper12
  1. 1Academic Medical Center Amsterdam & Atrium Medical Center Heerlen, Amsterdam, The Netherlands
  2. 2Rheumazentrum Ruhrgebiet, Herne, Germany
  3. 3Oregon Health & Science University, Portland, Oregon, USA
  4. 4Department of Rheumatology, Cochin Hospital, Paris, France
  5. 5Department of Medicine, University of Alberta, Edmonton, Canada
  6. 6Swedish Medical Center, University of Washington, Seattle, Washington, USA
  7. 7Division of Rheumatology, University of Texas Health Science Center at Houston, Houston, Texas, USA
  8. 8Endokrinologikum Berlin, Berlin, Germany
  9. 9Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands
  10. 10UCB Pharma, Monheim, Germany
  11. 11UCB Pharma, Brussels, Belgium
  12. 12Rheumatology Department, University Hospital Charité, Berlin, Germany
  1. Correspondence to Professor Robert Landewé, Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam & Atrium Medical Center, Meibergdreef 9, Amsterdam 1105AZ, The Netherlands; landewe{at}rlandewe.nl

Abstract

Objectives To evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPID-axSpA (NCT01087762), an ongoing Phase 3 trial in patients with axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA).

Methods Patients with active axSpA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). In total 325 patients were randomised. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society 20) response at week 12. Secondary outcomes included change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Metrology Index (BASMI) linear.

Results Baseline disease activity was similar between AS and nr-axSpA. At week 12, ASAS20 response rates were significantly higher in CZP 200 mg Q2W and CZP 400 mg Q4W arms versus placebo (57.7 and 63.6 vs 38.3, p≤0.004). At week 24, combined CZP arms showed significant (p<0.001) differences in change from baseline versus placebo in BASFI (−2.28 vs −0.40), BASDAI (−3.05 vs −1.05), and BASMI (−0.52 vs −0.07). Improvements were observed as early as week 1. Similar improvements were reported with CZP versus placebo in both AS and nr-axSpA subpopulations. Adverse events were reported in 70.4% vs 62.6%, and serious adverse events in 4.7% vs 4.7% of All CZP versus placebo groups. No deaths or malignancies were reported.

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

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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