title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Academic Medical Center Amsterdam & Atrium Medical Center Heerlen, , Amsterdam, The Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: Landewé
authors.forename: J
authors.initials: J
authors.lastname: Braun
authors.forename: A
authors.initials: A
authors.lastname: Deodhar
authors.forename: M
authors.initials: M
authors.lastname: Dougados
authors.forename: W P
authors.initials: WP
authors.lastname: Maksymowych
authors.forename: P J
authors.initials: PJ
authors.lastname: Mease
authors.forename: J D
authors.initials: JD
authors.lastname: Reveille
authors.forename: M
authors.initials: M
authors.lastname: Rudwaleit
authors.forename: D
authors.initials: D
authors.lastname: van der Heijde
authors.forename: C
authors.initials: C
authors.lastname: Stach
authors.forename: B
authors.initials: B
authors.lastname: Hoepken
authors.forename: A
authors.initials: A
authors.lastname: Fichtner
authors.forename: G
authors.initials: G
authors.lastname: Coteur
authors.forename: M
authors.initials: M
authors.lastname: de Longueville
authors.forename: J
authors.initials: J
authors.lastname: Sieper
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000068582:Certolizumab Pegol; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D025241:Spondylarthritis / Q000175:diagnosis / Q000188:drug therapy*; D013167:Spondylitis, Ankylosing / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007140:Immunoglobulin Fab Fragments; D007166:Immunosuppressive Agents; D010919:Placebos; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol