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Abstract Number: 2569

Association of Enthesitis with Achievement of Normal Quality of Life and Clinical Response in Patients with Non-Radiographic Axial Spondyloarthritis Treated with Adalimumab

Philip J. Mease1, Filip van Den Bosch2, Uta Kiltz3, Patrick Zueger4, Kun Chen4, Meijing Wu4 and Jaclyn K. Anderson4, 1Swedish Medical Center and University of Washington, Seattle, WA, 2Ghent University, Ghent, Belgium, 3Rheumazentrum Ruhrgebiet, Herne, Germany, 4AbbVie Inc., North Chicago, IL

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Adalimumab, axial spondyloarthritis, enthesis and quality of life

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Session Information

Date: Tuesday, October 23, 2018

Session Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose:

Enthesitis, a key pathology in non-radiographic axial spondyloarthritis (nr-axSpA), has been difficult to treat with conventional therapies and may take longer to resolve than other disease manifestations. It is unknown if failure to attain resolution of enthesitis affects achievement of normal quality of life (QoL) and clinical response. This analysis aimed to assess if enthesitis at baseline (BL) and after 12 wks of adalimumab (ADA) treatment in the ABILITY-3 study associates with achieving normal QoL and clinical response in patients (pts) with nr‑axSpA.

Methods:

ABILITY-3 enrolled adult pts with nr-axSpA with objective evidence of inflammation (MRI positive or elevated hsCRP), active disease at BL (ASDAS ≥2.1, BASDAI ≥4, and Patient’s Assessment of Total Back Pain score ≥4), and an inadequate response to ≥2 NSAIDs. Pts received ADA 40 mg every other wk during a 28-wk open-label lead-in. Pearson’s correlation coefficients were used to assess the relationship between total enthesitis count (sum of Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] and plantar fascia enthesitis score) and QoL and disease activity at BL. Multivariable stepwise logistic regression was used to evaluate the relationship between total enthesitis count/location and normal QoL (EQ-5D ≥0.898 or SF36 MCS/PCS ≥50) and clinical response (ASDAS-ID [ASDAS <1.3], ASAS40, or BASDAI50) at wk 12.

Results:

At BL, 74% (501/673) of pts had enthesitis, and mean (95% CI) total enthesitis count was 3.7 (3.42, 3.98). Enthesitis resolved in 39% (196/501) of pts, and total enthesitis count was 1.9 (1.68, 2.12) at wk 12 of ADA treatment. At BL, total enthesitis count significantly correlated with all QoL and disease activity measures (Table). Each 1-unit increase in BL total enthesitis count was associated with 7% lower odds of ASDAS-ID (OR [95% CI]; 0.93 [0.88, 0.99], P=0.018) and 6% lower odds of BASDAI50 (0.94 [0.89, 0.99], P=0.024) at wk 12 and was not associated with normal QoL or ASAS40 at wk 12. Total enthesitis count at wk 12 was associated with lower odds of normal QoL and clinical response at wk 12 (Table). Achievement of normal QoL at wk 12 was less likely if pts had BL enthesitis at the posterior (EQ-5D≥0.898) or anterior superior iliac spine (SF36 PCS≥50), and pts with BL enthesitis at the 7th costochondral joint were less likely to achieve clinical response at wk 12 (Table).

Conclusion:

39% of pts achieved complete resolution of enthesitis after 12 wks of ADA treatment. Total enthesitis count at BL was not associated with normal QoL and inversely associated with clinical response at wk 12. Total enthesitis count at wk 12 was negatively associated with normal QoL and clinical response. Our exploratory analysis suggested possible inverse associations of specific BL enthesitis sites with achievement of normal QoL and clinical response; additional research is needed to further define these relationships.

Table. Association of Total Enthesitis Count With QoL and Diseases Activity at BL and Clinical Response at Wk 12

Baseline

Measure

n

Pearson Correlation Coefficient

EQ-5D

672

–0.23*

SF-36 PCS

672

–0.18*

SF-36 MCS

672

–0.15*

BASDAI50

673

0.27*

ASDAS

673

0.18†

Patient Global Assessment

673

0.14*

Physician Global Assessment

671

0.17*

Wk 12

Measure

n

Odds Ratio (95% CI)

EQ-5D ≥0.898

658

0.62 (0.48, 0.78)*

SF-36 PCS ≥50

658

0.70 (0.61, 0.81)*

SF-36 MCS ≥50

658

0.85 (0.80, 0.91)*

ASDAS-ID

628

0.82 (0.75, 0.91)*

ASAS40

632

0.82 (0.76, 0.88)*

BASDAI50

632

0.74 (0.69, 0.81)*

Enthesitis Location at baseline

Measure at wk 12

n

Location

Odds Ratio (95% CI)

EQ-5D ≥0.898

660

Posterior superior iliac spine L/R

0.58 (0.34, 0.99)‡

SF-36 PCS ≥50

660

Anterior superior iliac spine L/R

0.60 (0.37, 0.96)‡

SF-36 MCS ≥50

663

—

—

ASDAS-ID

630

7th costochondral joint L/R

0.57 (0.36, 0.91)‡

ASAS40

637

7th costochondral joint L/R

0.62 (0.42, 0.91)‡

BASDAI50

634

7th costochondral joint L/R

0.60 (0.40, 0.91)‡

Locations evaluated included 1st costochondral joint L/R, 7th costochondral joint L/R, anterior superior iliac spine L/R, posterior superior iliac spine L/R, iliac crest L/R, 5th lumbar spinous process, proximal insertion of Achilles tendon L/R, and plantar fascia L/R. ASAS40, Assessment of SpondyloArthritis international Society 40% improvement; ASDAS-ID, Assessment of SpondyloArthritis international Society inactive disease; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; EQ-5D, EuroQol 5 dimension; MCS, mental component summary; PCS, physical component summary; QoL, quality of life; SF-36, short form health survey.

*P<0.001; †P<0.01; ‡P<0.05.


Disclosure: P. J. Mease, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB, 2,AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB, 5,AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer, and UCB, 8; F. van Den Bosch, AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB., 2, 5, 8; U. Kiltz, Pfizer, Inc., 2,AbbVie, Grünenthal, Novartis, and UCB, 5,AbbVie, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, and Roche., 8; P. Zueger, AbbVie Inc., 1, 3; K. Chen, AbbVie Inc., 1, 3; M. Wu, AbbVie Inc., 1, 3; J. K. Anderson, AbbVie Inc., 1, 3.

To cite this abstract in AMA style:

Mease PJ, van Den Bosch F, Kiltz U, Zueger P, Chen K, Wu M, Anderson JK. Association of Enthesitis with Achievement of Normal Quality of Life and Clinical Response in Patients with Non-Radiographic Axial Spondyloarthritis Treated with Adalimumab [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/association-of-enthesitis-with-achievement-of-normal-quality-of-life-and-clinical-response-in-patients-with-non-radiographic-axial-spondyloarthritis-treated-with-adalimumab/. Accessed January 24, 2021.
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