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SAT0337 Clinical Response and Remission in Patients with Non-Radiographic Axial Spondyloarthritis after Three Years of Adalimumab Therapy
  1. D. van der Heijde1,
  2. J. Sieper2,
  3. D.L. Baeten3,
  4. W.P. Maksymowych4,
  5. Y. Xia5,
  6. J.K. Anderson5,
  7. A.L. Pangan5
  1. 1Leiden University Medical Center, Leiden, Netherlands
  2. 2Charité Universitätsmedizin Berlin, Berlin, Germany
  3. 3Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands
  4. 4University of Alberta, Edmonton, Canada
  5. 5AbbVie Inc, North Chicago, United States

Abstract

Background Adalimumab (ADA) has been previously shown to be effective for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) patients (pts) in the ABILITY-1 trial.1 Week (wk) 12 results were further supported by sustained clinical response and remission data through Year 2 of the study.2

Objectives To evaluate the final Year 3 long-term response/remission and durability of response with ADA in pts with nr-axSpA.

Methods ABILITY-1 was a phase 3, double blind (DB), randomized, controlled trial in pts with nr-axSpA who had an inadequate response, intolerance, or contraindication to NSAIDs. A 12-wk DB period of ADA 40 mg every other week (eow) or placebo was followed by an open-label period in which pts could receive ADA 40 mg eow for up to an additional 144 wks. This post hoc analysis evaluated the final Year 3 (wk 156) efficacy and safety results for both the overall population and the MRI+/elevated CRP sub-population defined as those with a positive MRI at baseline (BL) (SPARCC score ≥2 for either the SI joints or spine) or an elevated CRP at BL. ASAS, BASDAI and ASDAS responses were calculated. Clinical remission was defined by ASDAS inactive disease (ASDAS ID, ASDAS <1.3) or by ASAS partial remission (ASAS PR).

Results Of the 185 pts enrolled in ABILITY-1, 122 (66%) had data available at wk 156 and 97 of 142 (68%) from the MRI+/elevated CRP sub-population. Clinical responses and remission rates were generally sustained between Year 2 and Year 3 of the study (Table 1). Through 412.2 patient-years (PYs) of exposure to ADA, the serious infection rate observed was 2.4 events/100 PYs, including 1 case of disseminated TB. There were 2 deaths – 1 due to suicide and another due to opiate toxicity. There were no malignancies reported.

Table 1.

Long-term clinical response and remission at years 2 and 3

Conclusions Almost half of the pts who remained on long-term ADA therapy in ABILITY-1 were in remission at the end of the study (Year 3), whether measured by ASAS PR or ASDAS ID. Results were similar between the overall population and the MRI+/elevated CRP sub-population.

References

  1. Sieper J et al. Ann Rheum Dis 2013;72:815–22.

  2. Sieper J et al. Ann Rheum Dis 2013;72(Suppl3):88.

Acknowledgements AbbVie funded the study (NCT00939003), contributed to its design and was involved in the collection, analysis, and interpretation of the data, and in the writing, review, and approval of the publication. Medical writing support was provided by Kathleen V. Kastenholz, PharmD, MS, of AbbVie.

Disclosure of Interest D. van der Heijde Grant/research support: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Covagen, Daiichi, Eli Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Covagen, Daiichi, Eli Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex, Employee of: Director of Imaging Rheumatology BV, J. Sieper Grant/research support: AbbVie, Merck, Pfizer, and UCB, Consultant for: AbbVie, Merck, Pfizer, and UCB, Speakers bureau: AbbVie, Merck, Pfizer, and UCB, D. Baeten Grant/research support: AbbVie, BMS, Boehringer Ingelheim, Centocor, Janssen, MSD, Novartis, Pfizer, and UCB, Consultant for: AbbVie, BMS, Boehringer Ingelheim, Centocor, Janssen, MSD, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, BMS, Boehringer Ingelheim, Centocor, Janssen, MSD, Novartis, Pfizer, and UCB, W. Maksymowych Grant/research support: AbbVie, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, and UCB, Consultant for: AbbVie, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, and UCB, Employee of: Chief Medical Officer of CaRE Arthritis, Y. Xia Shareholder of: AbbVie, Employee of: AbbVie, J. Anderson Shareholder of: AbbVie, Employee of: AbbVie, A. Pangan Shareholder of: AbbVie, Employee of: AbbVie

DOI 10.1136/annrheumdis-2014-eular.1696

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