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Clinical Trial
. 2018 Mar 27;20(1):61.
doi: 10.1186/s13075-018-1556-5.

Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial

Désirée van der Heijde  1 , Joachim Sieper  2 , Walter P Maksymowych  3 , Robert G Lambert  3 , Su Chen  4 , Maja Hojnik  5 , Jaclyn K Anderson  4 , Aileen L Pangan  4
Affiliations
Clinical Trial

Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial

Désirée van der Heijde et al. Arthritis Res Ther. .

Abstract

Background: Adalimumab was effective in treating patients with nonradiographic axial spondyloarthritis (nr-axSpA) in the 12-week ABILITY-1 trial. We present long-term efficacy and safety results of adalimumab from the open-label ABILITY-1 extension, including the relationship between clinical and magnetic resonance imaging (MRI) remission and impact of sustained clinical remission on physical function.

Methods: Patients received adalimumab 40 mg every other week or placebo for 12 weeks, then open-label adalimumab for up to 144 weeks. Clinical and safety data were collected through 3 years, and MRI data were collected until 2 years. Analyses were performed in the total population and subpopulation with positive MRI and/or elevated C-reactive protein (MRI/CRP-positive) at baseline. Clinical and MRI remission definitions included Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS ID; score < 1.3) and Spondyloarthritis Research Consortium of Canada (SPARCC) MRI score < 2 for sacroiliac joints (SIJs), spine, or both. Physical function was assessed using the Bath Ankylosing Spondylitis Functional Index.

Results: Overall, 185 patients were included in the total population and 142 in the MRI/CRP-positive subpopulation; 65% and 68%, respectively, completed 3 years. Clinical, functional, and MRI improvements were similar and equally sustainable in both populations. At year 3, the percentages of patients in ASDAS ID in the MRI/CRP-positive subpopulation were 30%/33% (nonresponder imputation) and 46%/49% (observed) for those initially receiving adalimumab/placebo. At years 1 and 2, patients in ASDAS ID vs not had significantly greater improvements in SPARCC SIJ scores from baseline (P < 0.001). Among patients with baseline MRI scores ≥ 2 who achieved ASDAS ID at year 2, 44-68% also had MRI remission. Significantly more patients with sustained ASDAS ID through year 2 or 3 vs without achieved normal physical function (100% vs 48%; 100% vs 44%; both P < 0.001). No new safety concerns were observed.

Conclusions: In the ABILITY-1 study of nr-axSpA, adalimumab therapy provided sustained clinical and functional improvements through 3 years, as well as suppression of MRI axial inflammation, which was greater in patients who achieved clinical remission. Sustained clinical remission was associated with increased attainment of normal physical function. The safety profile of adalimumab was consistent with prior studies.

Trial registration: ClinicalTrials.gov , NCT00939003 ; registered on July 10, 2009.

Keywords: Adalimumab; Anti-TNF; Axial spondyloarthritis.

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Conflict of interest statement

Ethics approval and consent to participate

This study was conducted in accordance with the International Conference on Harmonization good clinical practice guideline and the Declaration of Helsinki. Approval of an institutional ethics review board and voluntary written informed patient consent were obtained prior to initiation of study procedures.

Consent for publication

Not applicable.

Competing interests

DvdH has received consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and UCB and is director of Imaging Rheumatology B.V. JS has received research grants, consulting fees, and speaker’s fees from AbbVie, Merck, Pfizer, and UCB. WPM has received research grants and consulting fees from AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, Pfizer, SYNARC, and UCB and is chief medical officer of CaRE Arthritis. RGL has received consulting or advisory board fees from AbbVie, BioClinica, Janssen, Parexel, and UCB. SC, MH, JKA, and ALP are full-time employees of AbbVie and may hold stock and/or options.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Patient disposition in the total efficacy and MRI/CRP-positive populations over 3 years. *Other reasons included lack of efficacy, pregnancy, investigator decision, patient moved, and protocol violation. OL Open label, OLE Open-label extension
Fig. 2
Fig. 2
Mean ASDAS and BASDAI scores over 3 years. Mean ASDAS in the (a) MRI/CRP-positive subpopulation and (b) total efficacy population and mean BASDAI in the (c) MRI/CRP-positive subpopulation and (d) total efficacy population. Observed data (closed gray symbols) and LOCF data (open black symbols) through 3 years of OLE. Dashed line represents the start of the open-label adalimumab period; n values below the x-axis are for observed data at each visit, and n values in the figure legend are for the LOCF data. ASDAS Ankylosing Spondylitis Disease Activity Score, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, CRP C-reactive protein, LOCF last observation carried forward, MRI magnetic resonance imaging
Fig. 3
Fig. 3
Mean BASFI scores over 3 years. Mean BASFI in the (a) MRI/CRP-positive subpopulation and (b) total efficacy population. Observed data (closed gray symbols) and LOCF data (open black symbols) through 3 years of OLE. Dashed lines represent the start of the open-label adalimumab period; n values below the x-axis are for observed data at each visit, and n values in the figure legend are for the LOCF data. BASFI Bath Ankylosing Spondylitis Functional Index, CRP C-reactive protein, LOCF last observation carried forward, MRI magnetic resonance imaging
Fig. 4
Fig. 4
Proportion of patients achieving clinical remission over 3 years. ASAS partial remission in the (a) MRI/CRP-positive subpopulation and (b) total efficacy population and ASDAS ID (ASDAS < 1.3) in the (c) MRI/CRP-positive subpopulation and (d) total efficacy population. Observed data are shown with closed gray symbols and NRI data with open black symbols; the dashed line represents the start of the open-label adalimumab period. n Values below the x-axis are for observed data at each visit. n Values in the figure legend are for NRI data; patients who permanently discontinued at or prior to week 12 (double-blind phase) were excluded from open-label phase analyses (MRI/CRP-positive subpopulation, n = 3; total efficacy population, n = 6). ASAS Assessment of SpondyloArthritis international Society, ASDAS Ankylosing Spondylitis Disease Activity Score, CRP C-reactive protein, ID Inactive disease,  MRI Magnetic resonance imaging, NRI Nonresponder imputation
Fig. 5
Fig. 5
Change from baseline in SPARCC MRI scores among patients who achieved clinical remission. Mean (SE) change from baseline in the SIJ and spine SPARCC MRI scores in patients who achieved ASDAS ID vs those who did not in the (a) MRI/CRP-positive subpopulation and (b) total efficacy population at years 1 and 2. Observed data. P values for comparison of patients in remission vs patients not in remission from analysis of variance. ASDAS ID Ankylosing Spondylitis Disease Activity Score inactive disease, CRP C-reactive protein, MRI Magnetic resonance imaging, SIJ Sacroiliac joint, SPARCC Spondyloarthritis Research Consortium of Canada
Fig. 6
Fig. 6
Patients in sustained remission achieving normal physical function at years 2 and 3. Analysis of patients in the MRI/CRP-positive subpopulation with abnormal physical function at baseline (normal function defined as BASFI ≤ 3). Sustained clinical remission was defined as achieving ASDAS < 1.3 at all available visits during year 2 (from week 52 to week 104), during year 3 (from week 104 to week 156), and during both years 2 and 3 (from week 52 to week 156). ASDAS Ankylosing Spondylitis Disease Activity Score, BASFI Bath Ankylosing Spondylitis Functional Index, CRP C-reactive protein, MRI Magnetic resonance imaging
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