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Original article
Long-term efficacy and predictors of remission following adalimumab treatment in peripheral spondyloarthritis: 3-year results from ABILITY-2
  1. Filip Van den Bosch1,
  2. Philip J Mease2,
  3. Joachim Sieper3,
  4. Dominique L Baeten4,
  5. Yinglin Xia5,
  6. Su Chen6,
  7. Aileen L Pangan7 and
  8. In-Ho Song7
  1. 1Department of Rheumatology, Ghent University Hospital, Ghent, Belgium
  2. 2Swedish Medical Center and University of Washington, Seattle, Washington, USA
  3. 3Department of Gastroenterology, Infectiology, and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany
  4. 4Department of Experimental Immunology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
  5. 5Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA
  6. 6Data and Statistical Sciences, AbbVie Inc., North Chicago, Illinois, USA
  7. 7Immunology Clinical Development, AbbVie Inc., North Chicago, Illinois, USA
  1. Correspondence to Professor Philip J Mease; pmease{at}philipmease.com

Abstract

Objectives Describe efficacy and safety of 3 years of adalimumab treatment in patients with peripheral spondyloarthritis (pSpA) and identify predictors of remission.

Methods Patients with pSpA were randomised to adalimumab 40 mg every other week or placebo for 12 weeks; a 144-week open-label extension followed (NCT01064856). Remission was assessed by the Peripheral SpA Response Criteria (PSpARC) and Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS ID). Logistic regression analyses were performed to determine predictors of remission at 1 and 3 years and sustained remission (≥24 consecutive weeks).

Results In 165 patients, ASDAS ID was achieved by 47% at 1 year and 39% at 3 years; 36% and 33% achieved PSpARC remission, respectively. Sustained ASDAS ID and PSpARC remission were achieved by 52% (86/165) and 42% (70/165) of patients, respectively. Achieving ASDAS ID at week 12 significantly predicted 1 year (OR, 8.64 (95% CI 2.97 to 25.14)), 3 year (OR, 36.12 (95% CI 2.29 to 569.08)) and sustained ASDAS ID (OR, 8.01 (95% CI 2.47 to 25.97)); achieving PSpARC remission at week 12 consistently predicted 1 year (OR, 6.47 (95% CI 1.91 to 21.95)), 3 years (OR, 15.66 (95% CI 4.19 to 58.56)) and sustained PSpARC remission (OR, 20.27 (95% CI 5.37 to 76.46)). No baseline variables consistently predicted 1-year or 3-year remission or sustained remission. The safety profile of adalimumab was consistent with observations in other SpA disease indications.

Conclusions In patients with pSpA, early response to adalimumab, but not baseline demographics or disease characteristics, was a better predictor of long-term remission.

  • spondyloarthritis
  • treatment
  • anti-tnf
  • disease activity

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) 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/4.0/

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Footnotes

  • Contributors The authors and AbbVie scientists designed the study and analysed and interpreted the data. All authors contributed to the development of the content; all authors and AbbVie reviewed and approved the manuscript; the authors maintained control over the final content.

  • Funding This work was supported by AbbVie Inc.

  • Competing interests FVdB has received research grants, consulting fees and speaker’s fees from AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB. PJM has received research grants, consulting fees and/or speaker’s fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Sun and UCB. JS has received research grants, consulting fees and speaker’s fees from AbbVie, Merck, Pfizer and UCB. DLB is a part-time employee of UCB and has received funding from AbbVie, Pfizer, MSD, UCB, Janssen, Novartis, Eli Lilly, Boehringer Ingelheim, BMS, Roche and Glenmark. YX is a former employee of AbbVie and may own AbbVie stock and/or options. SC, ALP and I-HS are employees of AbbVie and may own AbbVie stock and/or options.

  • Ethics approval The study was approved by the ethics review board of the main institution (Western Institutional Review Board; date of approval: 20 May 2010; ethics approval/site number: 4935W-10) and ethics review boards of each additional centre that participated in the study.

  • Provenance and peer review Not commissioned; externally peer reviewed.