title: Serum C-reactive Protein Levels Demonstrate Predictive Value for Radiographic and Magnetic Resonance Imaging Outcomes in Patients with Active Ankylosing Spondylitis Treated with Golimumab.
abstract: Serum C-reactive protein (CRP) associates with radiographic progression in patients with ankylosing spondylitis (AS) untreated with tumor necrosis factor (TNF) antagonists. We assessed correlations between serum CRP and radiographic progression/magnetic resonance imaging (MRI)-detected inflammation after 2 years of anti-TNF therapy.
  
  
  
  Patients with active AS receiving golimumab (GOL)/placebo through Week 16 (early escape) or Week 24 (crossover by design), followed by GOL through 4 years, had sera/images obtained through Week 208. Lateral spinal radiographs and spinal MRI were scored with the modified Stoke AS Spine Score (mSASSS) and the AS spine MRI activity (ASspiMRI-a) score, respectively. ANOVA assessed differences based on CRP levels and mSASSS progression. The relationships between CRP levels and mSASSS/ASspiMRI-a were assessed by Spearman correlation and logistic regression.
  
  
  
  Of the randomized GO-RAISE patients, 299 (84.0%) had pre- and posttreatment spinal radiographs. Larger proportions of patients with Week 104 CRP ≥ 0.5 mg/dl (n = 47) versus < 0.5 mg/dl (n = 236, 40.4% vs 22.9%, p = 0.0121) had mSASSS changes ≥ 2 at Week 104. Across several visits, serum CRP demonstrated weak associations with mSASSS change (rs ≤ 0.21, p < 0.05, n = 262-293) and moderate associations with ASspiMRI-a change (rs = -0.33 to 0.54, p < 0.05, n = 65-89). Higher baseline CRP was associated with increased risk for syndesmophytes at Week 104/Week 208, and large, short-term decreases in CRP from baseline to Week 14/Week 24 also yielded increased syndesmophyte formation risk.
  
  
  
  Elevated CRP after 2 years of anti-TNF treatment correlated with greater radiographic progression risk at 4 years. Elevated CRP at baseline or Week 14/Week 24 of anti-TNF treatment weakly predicted subsequent radiographic progression and modestly predicted residual spinal inflammation in patients with AS treated with anti-TNF. Findings are useful regarding new treatment options in patients treated with anti-TNF. ClinicalTrials.gov: NCT00265083.
authors.affiliation: From the Rheumazentrum Ruhrgebiet, Herne; Ruhr-University Bochum, Bochum; Department of Radiology, Charité Universitätsmedizin, Berlin, Germany; Biostatistics and Immunology, Janssen Research and Development LLC, Spring House, Pennsylvania, USA.J. Braun has received honoraria for talks, advisory boards, paid consultancies, and grants for studies from Janssen Research and Development LLC. X. Baraliakos has received honoraria for talks, advisory boards, paid consultancies, and grants for studies from Janssen. K.G. Hermann has received honoraria for educational lectures from Janssen. S. Xu and B. Hsu are employees of Janssen.J. Braun, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum; K.G. Hermann, MD, PhD, Department of Radiology, Charité Universitätsmedizin; S. Xu, MS, Biostatistics, Janssen Research and Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research and Development LLC. j.braun@rheumazentrum-ruhrgebiet.de.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Braun
authors.affiliation: From the Rheumazentrum Ruhrgebiet, Herne; Ruhr-University Bochum, Bochum; Department of Radiology, Charité Universitätsmedizin, Berlin, Germany; Biostatistics and Immunology, Janssen Research and Development LLC, Spring House, Pennsylvania, USA.J. Braun has received honoraria for talks, advisory boards, paid consultancies, and grants for studies from Janssen Research and Development LLC. X. Baraliakos has received honoraria for talks, advisory boards, paid consultancies, and grants for studies from Janssen. K.G. Hermann has received honoraria for educational lectures from Janssen. S. Xu and B. Hsu are employees of Janssen.J. Braun, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum; K.G. Hermann, MD, PhD, Department of Radiology, Charité Universitätsmedizin; S. Xu, MS, Biostatistics, Janssen Research and Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research and Development LLC.
authors.forename: Xenofon
authors.initials: X
authors.lastname: Baraliakos
authors.affiliation: From the Rheumazentrum Ruhrgebiet, Herne; Ruhr-University Bochum, Bochum; Department of Radiology, Charité Universitätsmedizin, Berlin, Germany; Biostatistics and Immunology, Janssen Research and Development LLC, Spring House, Pennsylvania, USA.J. Braun has received honoraria for talks, advisory boards, paid consultancies, and grants for studies from Janssen Research and Development LLC. X. Baraliakos has received honoraria for talks, advisory boards, paid consultancies, and grants for studies from Janssen. K.G. Hermann has received honoraria for educational lectures from Janssen. S. Xu and B. Hsu are employees of Janssen.J. Braun, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum; K.G. Hermann, MD, PhD, Department of Radiology, Charité Universitätsmedizin; S. Xu, MS, Biostatistics, Janssen Research and Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research and Development LLC.
authors.forename: Kay-Geert A
authors.initials: KG
authors.lastname: Hermann
authors.affiliation: From the Rheumazentrum Ruhrgebiet, Herne; Ruhr-University Bochum, Bochum; Department of Radiology, Charité Universitätsmedizin, Berlin, Germany; Biostatistics and Immunology, Janssen Research and Development LLC, Spring House, Pennsylvania, USA.J. Braun has received honoraria for talks, advisory boards, paid consultancies, and grants for studies from Janssen Research and Development LLC. X. Baraliakos has received honoraria for talks, advisory boards, paid consultancies, and grants for studies from Janssen. K.G. Hermann has received honoraria for educational lectures from Janssen. S. Xu and B. Hsu are employees of Janssen.J. Braun, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum; K.G. Hermann, MD, PhD, Department of Radiology, Charité Universitätsmedizin; S. Xu, MS, Biostatistics, Janssen Research and Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research and Development LLC.
authors.forename: Stephen
authors.initials: S
authors.lastname: Xu
authors.affiliation: From the Rheumazentrum Ruhrgebiet, Herne; Ruhr-University Bochum, Bochum; Department of Radiology, Charité Universitätsmedizin, Berlin, Germany; Biostatistics and Immunology, Janssen Research and Development LLC, Spring House, Pennsylvania, USA.J. Braun has received honoraria for talks, advisory boards, paid consultancies, and grants for studies from Janssen Research and Development LLC. X. Baraliakos has received honoraria for talks, advisory boards, paid consultancies, and grants for studies from Janssen. K.G. Hermann has received honoraria for educational lectures from Janssen. S. Xu and B. Hsu are employees of Janssen.J. Braun, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum; K.G. Hermann, MD, PhD, Department of Radiology, Charité Universitätsmedizin; S. Xu, MS, Biostatistics, Janssen Research and Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research and Development LLC.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Hsu
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000378:metabolism*; D018592:Cross-Over Studies; D018450:Disease Progression; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D013131:Spine / Q000000981:diagnostic imaging*; D013167:Spondylitis, Ankylosing / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D002097:C-Reactive Protein; C529000:golimumab
keywords: ANKYLOSING SPONDYLITIS; C-REACTIVE PROTEIN; GOLIMUMAB; MAGNETIC RESONANCE IMAGING; RADIOGRAPH; TUMOR NECROSIS FACTOR