Background Adalimumab (ADA) significantly improved clinical response at wk 12 vs placebo in patients (pts) with non-radiographic axial spondyloarthritis (nr-axSpA) in the ABILITY-1 study. The subsequent, ongoing ABILITY-3 study is assessing continuation vs withdrawal of ADA in nr-axSpA pts who respond to ADA.
Objectives Evaluate the efficacy and safety of ADA during the open-label lead-in period of ABILITY-3.
Methods ABILITY-3 has a 28-wk lead-in open-label ADA (40 mg every other wk) period; pts who achieve sustained remission (Ankylosing Spondylitis Disease Activity Score inactive disease [ASDAS ID] at wks 16, 20, 24 and 28) are randomized to double-blind placebo (withdrawal) or ADA (continuation) for 40 wks (ongoing). From wk 20–28, pts who did not achieve ASDAS ID were discontinued. Adult pts with nr-axSpA (fulfilling Assessment of SpondyloArthritis international Society [ASAS] criteria but not modified New York criteria) with objective evidence of inflammation in the sacroiliac joints or spine on MRI or elevated hs-CRP at screening; active disease at baseline (defined by ASDAS ≥2.1, BASDAI ≥4, and total back pain score ≥4); and inadequate response to ≥2 NSAIDs were eligible.
Results Of 673 pts enrolled, 51% were women and mean BASDAI was 7.0±1.4 (Table). At wk 28, 305 (45%) pts were randomized (ASDAS ID: 33% at wk 12, 44% sustained at wk 28; nonresponder imputation) and 368 (55%) pts discontinued (not achieving sustained remission, n=300 [45%]; other reasons, n=68 [10%]). In observed analysis, 59%, 35%, and 22% of pts achieved ASAS40, ASDAS ID, and ASAS partial remission, respectively, at wk 12, similar to wk 12 data from ABILITY-1 pts with objective inflammation at baseline. The proportions of pts achieving ASAS20, ASAS40, ASDAS ID, ASDAS CII, and ASDAS MI increased, and mean BASDAI and back pain scores decreased over time (observed analysis; Figure). Adverse events (AEs) were reported by 468 pts (70%), most commonly nasopharyngitis (n=121 [18%]), upper respiratory tract infection (n=81 [12%]), and headache (n=56 [8%]); serious AEs occurred in 19 (3%) pts.
Conclusions Baseline disease activity was higher in ABILITY-3 pts than reported in prior trials. After 28 wks of open-label ADA therapy, disease activity improved and sustained remission was achieved in 44% of pts. Efficacy and safety in this nr-axSpA population were consistent with findings from ABILITY-1.
Acknowledgements AbbVie funded the study and approved the abstract for submission. Medical writing support was provided by Maria Hovenden, PhD, of Complete Publication Solutions, LLC (North Wales, PA) and was funded by AbbVie.
Disclosure of Interest R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, and Wyeth, Consultant for: 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, Speakers bureau: Abbott/AbbVie, Amgen, Bristol Myers Squibb, Janssen (formerly Centocor), Merck, Pfizer, Roche, Schering-Plough, UCB, and Wyeth, 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, R. Inman Grant/research support from: AbbVie, Amgen, Janssen, Lilly, and Novartis, A. Pangan Employee of: AbbVie, X. Wang Employee of: AbbVie, J. Anderson Employee of: AbbVie