SAT0263 Predictors of remission maintenance and successful therapy discontinuation in patients with non-radiographic axial spondyloarthritis (NR-AXSPA) who achieved sustained remission on open-label adalimumab (ADA) treatment
Authors: J. Sieper, R. Landewé, M. Magrey, J. Anderson, S. Zhong, X. Wang, A. Lertratanakul
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Sustained remission is an important treatment goal in patients (pts) with non-radiographic axial SpA (nr-axSpA). Factors predicting successful remission maintenance are unknown. <h3>Objectives</h3> We sought to identify predictors of remission maintenance in nr-axSpA pts who achieved remission after open-label (OL) adalimumab (ADA) treatment in the ABILITY-3 trial (NCT01808118) and were subsequently randomised to continuation or withdrawal of ADA therapy. <h3>Methods</h3> ABILITY-3 enrolled adult pts with nr-axSpA with objective evidence of active MRI inflammation in the SI joints or spine or elevated high-sensitivity CRP at screening, active disease at baseline (ASDAS≥2.1, BASDAI≥4, and Patient's Assessment of Total Back Pain score ≥4), and inadequate response to ≥2 NSAIDs (<b>table 1</b>). Pts received ADA 40 mg every other wk during a 28-wk OL lead-in period. Pts who achieved sustained remission, defined as ASDAS inactive disease [ID] score &lt;1.3 at wks 16, 20, 24, and 28, were randomised to double-blind withdrawal (placebo; PBO) or continued ADA for 40 wks during period 2 (study wk 68). Stepwise logistic regression was used to identify predictors of sustained remission in those in the continued ADA and withdrawal (PBO) groups. Remission maintenance in period 2 was assessed with the following: ASAS partial remission (PR; score ≤2.0) and ASDAS ID at wk 68, ASAS PR and ASDAS ID at every visit, and ASDAS ID for ≥5 of 10 visits. <h3>Results</h3> By wk 68, 100/145 (69%) ADA pts had not flared, 41% achieved ASAS PR and 56% ASDAS ID at wk 68; 23% achieved ASAS PR and 29% ASDAS ID at every visit, while 70% achieved ASDAS ID for ≥5 of 10 visits. By wk 68, 70/148 (47%) PBO pts had not flared, 28% achieved ASAS PR and 33% ASDAS ID at wk 68; 14% achieved ASAS PR and 15% ASDAS ID at every visit, while 52% achieved ASDAS ID for ≥5 of 10 visits. Shorter symptom duration, lower wk 28 BASDAI, and male sex were associated with absence of flare in the continued ADA group. Lower wk 28 ASDAS was associated with absence of flare with ADA withdrawal. Lower wk 28 ASDAS consistently predicted ASAS PR and ASDAS ID at wk 68, ASAS PR and ASDAS ID at every visit, and ASDAS ID for ≥5 of 10 visits in pts who continued or withdrew ADA. <h3>Conclusions</h3> In nr-axSpA pts who achieved remission after 28-wk OL ADA therapy, lower wk 28 ASDAS is a consistent predictor of remission maintenance using all definitions in both the adalimumab continuation and withdrawal groups, except absence of flare in the adalimumab continuation group, suggesting early aggressive treatment may be beneficial in achieving sustained remission. <h3>Acknowledgements</h3> AbbVie funded the study, contributed to its design and participated in data collection, analysis and interpretation of the data, and in writing, review, and approval of the publication. Medical writing support was provided by Maria Hovenden, PhD, and Janet E. Matsuura, PhD, of Complete Publication Solutions, LLC (North Wales, PA) and was funded by AbbVie. <h3>Disclosure of Interest</h3> J. Sieper Consultant for: AbbVie, Janssen, Lilly, Merck, Novartis, Pfizer, Sun Pharma, and UCB, Speakers bureau: AbbVie, Janssen, Lilly, Merck, Novartis, and Pfizer., R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, and Wyeth, Consultant for: consulting or advisory board fees from Abbott/AbbVie, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Celgene, Janssen (formerly Centocor), Galapagos, GlaxoSmithKline, Novartis, Novo-Nordisk, Merck, Pfizer, Roche, Schering-Plough, TiGenix, UCB, and Wyeth, Employee of: he is director of Rheumatology Consultancy BV, a registered Dutch company., Speakers bureau: Abbott/AbbVie, Amgen, Bristol Myers Squibb, Janssen (formerly Centocor), Merck, Pfizer, Roche, Schering-Plough, UCB, Wyeth, M. Magrey Grant/research support from: Amgen, AbbVie, and UCB Pharma, Consultant for: UCB and Janssen, J. Anderson Shareholder of: AbbVie, Employee of: AbbVie, S. Zhong Shareholder of: AbbVie, Employee of: AbbVie, X. Wang Shareholder of: AbbVie, Employee of: AbbVie, A. Lertratanakul Shareholder of: AbbVie, Employee of: AbbVie