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THU0403 Performance of Modified Minimal Disease Activity (MDA) Criteria in Patients with Peripheral Spondyloarthritis: Post-Hoc Analysis of Ability-2
  1. L.C. Coates1,2,
  2. S. Abraham3,
  3. W. Tillett4,
  4. P.J. Mease5,
  5. S. Ramiro6,
  6. Y. Xia7,
  7. X. Wang8,
  8. A.L. Pangan8,
  9. I.-H. Song8
  1. 1Leeds Teaching Hospitals NHS Trust
  2. 2University of Leeds, Leeds
  3. 3NIHR/Wellcome CRF, Imperial college Healthcare NHS trust, London
  4. 4Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom
  5. 5Swedish Medical Center and University of Washington, Seattle, United States
  6. 6Leiden University Medical Center, Leiden, Netherlands
  7. 7University of Illinois at Chicago, Chicago
  8. 8AbbVie Inc, North Chicago, United States

Abstract

Background Due to lack of validated outcome measures in non-psoriatic peripheral spondyloarthritis (pSpA), recent studies in this patient (pt) population have used varying endpoints [1]. Thus, developing new pSpA-specific indices may be worthwhile. Minimal Disease Activity (MDA) has been validated in psoriatic arthritis but not in pSpA.

Objectives To evaluate the performance of a modification of the MDA criteria (excluding psoriasis) in pSpA patients (pts) from the ABILITY-2 study [2].

Methods This post-hoc analysis evaluated the validity of a modified MDA (mMDA) in pSpA. ABILITY-2 was a 12-week trial comparing adalimumab (ADA) with placebo (PBO) in pSpA followed by a 144 week extension. The mMDA for pSpA was defined as achieving at least 4 or 5 out of the following 6 criteria: (1) tender joint count (TJC, 78 joints) ≤1; (2) swollen joint count (SJC, 76 joints) ≤1; (3) pt pain visual analog scale (VAS) ≤15 of 100 mm; (4) pt global activity (PtGA) VAS ≤20 of 100 mm; (5) health assessment questionnaire–disability index (HAQ-DI)≤0.5; and (6) tender entheseal points ≤1. Enthesitis was assessed by the Leeds Enthesitis Index (LEI) or the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index for this analysis. The proportion of pts achieving the 4 different versions of mMDA were evaluated (either 4 or 5 of 6 using LEI and either 4 or 5 of 6 using SPARCC). The correlations between mMDA and the novel pSpA response criteria [PSpARC] remission from ABILITY-2 and Ankylosing Spondylitis Disease Activity Score Inactive Disease [ASDAS ID] were evaluated by tetrachoric correlation (rtet).

Results Of the 163 pts (82 ADA, 81 PBO) who completed wk 12, significantly greater proportion of pts receiving ADA achieved mMDA (regardless of the definition) compared with PBO (P<0.001 for all comparisons, Table 1a). The proportion of mMDA responders at yrs 1, 2, and 3 was numerically higher in pts initially randomized to ADA. The mMDA response showed a stronger positive correlation with PSpARC remission (rtet>0.9) than ASDAS ID (rtet>0.75) at wk 12, and yrs 1–3. Among pts who fulfilled the 4/6 criteria (LEI or SPARCC), approximately 20–30% of pts did not meet TJC and SJC criterion (Table 1b). However, the 5/6 criteria (LEI or SPARCC) were more stringent with approximately 5% and 13% not meeting the TJC and SJC criterion, respectively.

Conclusions All 4 versions of mMDA discriminated between ADA and PBO treatment groups; both entheseal indices performed similarly. The mMDA (particularly the 5/6 versions which closely represents the concept of MDA) could be an appropriate treatment target in pSpA pts.

  1. Turina, M.C., et al., Ann Rheum Dis, 2015. (doi: 10.1136/annrheumdis-2014-207235).

  2. Mease, P., et al., Arthritis Rheumatol, 2015. 67(4): p. 914–23.

Acknowledgement AbbVie funded the study (NCT01064856), contributed to its design and participated in data collection, analysis and interpretation of the data, and in writing, review, and approval of the publication. Statistical support was provided by Nupun Varothai, former employee of AbbVie. Medical writing was provided by Deepa Venkitaramani, PhD, of AbbVie.

Disclosure of Interest L. Coates Grant/research support from: AbbVie, Celgene, Janssen, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Celgene, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Pfizer, and UCB, S. Abraham Grant/research support from: AbbVie, Celgene, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Celgene, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene, Novartis, Pfizer, and UCB, W. Tillett Grant/research support from: AbbVie, Celgene, Pfizer, and UCB, Consultant for: AbbVie, Celgene, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene, Pfizer, and UCB, P. Mease Grant/research support from: AbbVie, Amgen, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB., Consultant for: AbbVie, Amgen, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB., Speakers bureau: AbbVie, Amgen, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB., S. Ramiro: None declared, Y. Xia Employee of: Former AbbVie contract employee, X. Wang Shareholder of: AbbVie, Employee of: AbbVie, A. Pangan Shareholder of: AbbVie, Employee of: AbbVie, I.-H. Song Shareholder of: AbbVie, Employee of: AbbVie

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