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THU0240 Early Clinical Response is a Better Predictor of Long-Term Remission than Baseline Disease Characteristics Following Adalimumab Treatment in Peripheral Spondyloarthritis
  1. F. van den Bosch1,
  2. P. Mease2,
  3. J. Sieper3,
  4. D. Baeten4,
  5. N.A. Varothai5,
  6. A.L. Pangan5,
  7. I.-H. Song5
  1. 1Ghent University Hospital, Ghent, Belgium
  2. 2Swedish Medical Center and University of Washington, Seattle, United States
  3. 3Charité Universitätsmedizin Berlin, Berlin, Germany
  4. 4Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands
  5. 5AbbVie Inc., North Chicago, United States

Abstract

Background ABILITY-2 has demonstrated the efficacy of adalimumab (ADA) vs. placebo (PBO) over 12 weeks (wk) in patients (pt) with peripheral spondyloarthritis (pSpA)1 and sustained response following up to 2 years (yr) of ADA.

Objectives To determine predictors of long-term remission in pts with pSpA.

Methods In ABILITY-2 pts were randomized to receive ADA 40 mg every other wk or PBO during a 12-wk double-blind period, followed by an open-label period of up to 3 yrs of treatment. PSpARC1 remission was defined as SJC ≤1 plus 4/5 of the following: Physician's Global Assessment (PGA) of Disease Activity ≤20 mm (visual analog scale, VAS); PGA-pain ≤20 mm VAS, TJC ≤1, enthesitis count ≤1, dactylitis count ≤1. ASDAS inactive disease (ASDAS ID) was ASDAS score <1.3. Possible predictors for remission at 1 and 3 yrs of ADA treatment were selected a priori. Categorical variables included symptom duration, abnormal baseline (BL) hs-CRP, HLA-B27+, and response at wk 12 for BASDAI50, PSpARC, and ASDAS categories. Continuous variables included BL values for TJC, SJC, enthesitis count, BASDAI, ASDAS, Patient Global Assessment of disease activity (PtGA), PGA, and hs-CRP. Univariate logistic regression was used to evaluate predictors for remission variables at yrs 1 and 3. Multivariate analysis was done to determine predictors of achieving sustained (≥3 consecutive visits) remission at any time during the study.

Results 165 pts (ADA 84/PBO 81) were randomized. Among pts completing both yr 1 and 3, 48.2% (54/112) of pts achieved PSpARC remission and 58.9% (63/107) were in ASDAS ID at yr 3. Univariate analysis showed that wk 12 responses were more consistent predictors of remission at yr 1 or 3 (Figure) than most BL disease characteristics. Abnormal BL hs-CRP was a predictor of PSpARC remission at yr 3, but not at yr 1. Furthermore, abnormal BL hs-CRP was not a predictor of ASDAS ID at yr 1 or 3. 44.9% (74/165) and 57.6% (95/165) achieved sustained PSpARC remission and ASDAS ID, respectively, during the 3-yr study. Multivariate analysis demonstrated that PSpARC remission at wk 12 predicted sustained PSpARC remission (Odds ratio (OR) 95.96, P=0.0023) and ASDAS ID at wk 12 predicted sustained ASDAS ID (OR 46.29, P=0.0084).

Conclusions Early response to ADA in pSpA patients is a better predictor of long-term remission for up to 3 years, whether at a single point in time or sustained over time, than baseline disease characteristics.

References

  1. Mease P et al. Arthritis Rheumatol 2014; Accepted Dec 29. DOI 10.1002/art.39008.

Acknowledgements AbbVie funded the study (NCT01064856), 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. Statistical support was provided by Yinglin Xia, funded by AbbVie. Medical writing support was provided by Kathleen V. Kastenholz, PharmD, MS, of AbbVie.

Disclosure of Interest F. Van den Bosch Grant/research support from: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, and UCB, P. Mease Grant/research support from: AbbVie, Amgen, Biogen Idec, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, and Vertex, Consultant for: AbbVie, Amgen, Biogen Idec, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, and Vertex, Speakers bureau: AbbVie, Amgen, Biogen Idec, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, and Vertex, J. Sieper Grant/research support from: AbbVie, Merck, Pfizer, and UCB, Consultant for: AbbVie, Merck, Pfizer, and UCB, Speakers bureau: AbbVie, Merck, Pfizer, and UCB, D. Baeten Grant/research support from: 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, N. Varothai 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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