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SAT0258 Baseline MRI/CRP as Predictors of Response to Etanercept in the Management of Patients with Non-Radiographic Axial Spondyloarthritis
  1. M.A. Brown1,
  2. P.A. Bird1,
  3. P.C. Robinson2,
  4. P. Mease3,
  5. F. van den Bosch4,
  6. C. Surian5,
  7. Z. Wiid5,
  8. H. Jones6,
  9. A. Szumski6,
  10. L. Marshall6
  1. 1Diamantina Institute, University of Queensland
  2. 2University of Queensland & Royal Brisbane and Women's Hospital, Brisbane, Australia
  3. 3Swedish Medical Center and University of Washington, Seattle, United States
  4. 4Ghent University Hospital, Ghent, Belgium
  5. 5Pfizer Australia, Sydney, Australia
  6. 6Pfizer Inc, Collegeville, United States


Background Treatment with TNFα inhibitors has been shown to be effective in improving disease activity and functional capacity in patients with non-radiographic axial spondyloarthritis (nr-axSpA). Evidence indicates that clinical response to anti-TNFα agents tends to be enhanced in nr-axSpA patients with magnetic resonance imaging (MRI)-documented sacroiliac (SI) joint inflammation and elevated C-reactive protein (CRP).

Objectives To determine if MRI sacroiliitis positivity and/or elevated CRP at baseline are predictive or associated with changes in measures of disease activity following etanercept (ETN) treatment in patients with nr-axSpA.

Methods Patients with symptom duration >3 mths–<5 yrs, meeting ASAS axSpA classification criteria but not radiographic criteria for ankylosing spondylitis, having BASDAI ≥4, and failure with ≥2 NSAIDs were randomized to 12 wks of double-blind treatment with ETN 50mg QW or PBO. Both groups continued stable NSAID therapy. Standard clinical outcomes were assessed in 4 patient subgroups based on MRI sacroiliitis (positive/negative [+/-]) and CRP (elevated/normal [+/-]) status at baseline. MRI sacroiliitis positivity was defined as SPARCC SI joint score ≥2; elevated CRP was defined as >3 mg/L.

Results A total of 200 subjects (ETN, n=95; PBO, n=105) were included in these analyses. At baseline, breakdown according to MRI sacroiliitis and CRP status was: MRI-/CRP-, n=38; MRI+/CRP-, n=74; MRI-/CRP+, n=21; MRI+/CRP+, n=67. At Week 12, the primary endpoint of ASAS40 was achieved by more patients receiving ETN than those receiving PBO irrespective of MRI/CRP status at baseline (Table). The greatest ASAS40 response was observed in patients with MRI+/CRP+ at baseline and the lowest response was seen in the MRI-/CRP- subgroup. Similar observations were made for all other clinical endpoints with a markedly higher proportion of MRI+/CRP+ patients achieving ASAS20, BASDAI50 and clinically important improvements (Δ≥1.1) in ASDAS-CRP/ESR than those in the other MRI/CRP subgroups.

Table 1

Conclusions Our findings, in patients with early, active nr-axSpA and an inadequate response to ≥2 NSAIDs, are consistent with the hypothesis that a combination of MRI positivity and elevated hsCRP at baseline has a positive predictive value on the SI joint inflammation score and a better clinical response to ETN. A larger sample size is required to test this definitively.

Disclosure of Interest M. Brown Grant/research support from: Abbvie, Pfizer, UCB, Wyeth, Leo Pharma, NIAMS, NHMRC, Arthritis Australia, Qld Government, Consultant for: Pfizer, Abbvie, UCB, Speakers bureau: Pfizer, Abbvie, UCB, P. Bird Speakers bureau: Pfizer, Abbvie, Roche, Janssen, BMS, P. Robinson Grant/research support from: NHMRC, ARA, RACP, Consultant for: Pfizer, UCB, Abbvie, Janssen, Menarini, Speakers bureau: Menarini, Janssen, Abbvie, UCB, P. Mease Grant/research support from: AbbVie, Amgen, Biogen Idec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, Consultant for: AbbVie, Amgen, Biogen Idec, BMS, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Biogen Idec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Pfizer, UCB, F. van den Bosch Consultant for: Abbvie, Celgene, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Janssen, Novartis, Pfizer, UCB, C. Surian Employee of: Pfizer, Z. Wiid Employee of: Pfizer, H. Jones Employee of: Pfizer, A. Szumski Consultant for: Employee of inVentiv Health and was contracted by Pfizer Inc. to provide statistical support, L. Marshall Employee of: Pfizer

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