ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2802

Sustained Remission of Inflammation Is Associated with Reduced Structural Damage on SI Joint MRI in Patients with Early Axial Spa: Evidence to Support the Concept of Treat-to-Target

Walter P. Maksymowych1, Pascal Claudepierre2, Manouk de Hooge3, Robert G. Lambert4, Robert B.M. Landewé5, Anna Molto6, Désirée van der Heijde3, Jack F Bukowski7, Heather Jones8, Isabelle Logeart9, Lisa Marshall8, Ronald Pedersen10, Annette Szumski11, Bonnie Vlahos12 and Maxime Dougados13, 1Radiology & Diagnostic Imaging, University of Alberta, Edmonton, AB, Canada, 2Universite Paris Est Creteil, Paris, France, 3Leiden University Medical Center, Leiden, Netherlands, 4Department of Radiology & Diagnostic Imaging, University of Alberta, Edmonton, AB, Canada, 5Amsterdam Rheumatology & Immunology Center, Amsterdam, Netherlands, 6Hôpital Cochin, Department of Rheumatology, Paris Descartes University, Paris, France, 7Clinical Affairs, Pfizer, Collegeville, PA, 8Inflammation & Immunology Global Medical Affairs, Pfizer, Collegeville, PA, 9Medical Affairs, Pfizer, France, Paris, France, 10Department of Biostatistics, Pfizer, Collegeville, PA, 11Biostatistics, inVentiv Health, Princeton, NJ, 12Clinical Sciences, Pfizer, Collegeville, PA, 13Hopital Cochin, Paris Descartes University, Paris, France

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: ,

Session Information

Date: Tuesday, November 7, 2017

Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment III

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose:

Treat-to-target is an accepted strategy in RA; however, it is unknown whether it will reduce/prevent disability, impairment of mobility, and structural damage in patients with early axial SpA (axSpA) who do not meet modified New York criteria for radiographic sacroiliitis. We evaluated the impact of sustained clinical remission on MRI structural parameters. We hypothesized that patients with sustained inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] <1.3) are more likely to achieve reduction in erosion (structural damage) and increase in backfill (a reparative process) on MRI of the SI joints (SIJ).

Methods:

The EMBARK (NCT01258738) and DESIR (NCT01648907) studies enrolled patients with early axSpA. EMBARK included a 12-week double-blind placebo-controlled period, then open-label etanercept for 92 weeks. DESIR patients had no history of biologic therapy and did not receive biologics for 2 years. T1 weighted MRI images of the SIJ at baseline (BL) and 104 weeks were combined and anonymized; readers were unaware of film chronology and original patient cohort. Three experienced readers evaluated the MRI images using the SpondyloArthritis Research Consortium of Canada (SPARCC) SIJ Structural Score (SSS). Change in erosion or backfill was considered present if 2 of 3 readers measured change in the same direction. ASDAS endpoints were: sustained inactive disease (ASDAS <1.3 for 2 visits 6 months apart) (yes/no); sustained ASDAS <2.1 for 2 visits 6 months apart (yes/no); and best sustained ASDAS response (<1.3, moderate disease activity [MDA, ≥1.3 to <2.1], or neither) for 2 visits 6 months apart. We determined the net proportion of patients with a change in each lesion. The results were unadjusted and also adjusted for covariates that may affect development of lesions on MRI.

Results:

In EMBARK and DESIR, 150 and 68 patients, respectively, had BL and 104-week MRI images and ASDAS measurements every 6 months. For the patients in EMBARK with sustained ASDAS inactive disease, the proportion with a decrease in erosion was significantly greater than with an increase, and the proportion with an increase in backfill was significantly greater than with a decrease, in both the unadjusted and adjusted analyses (Table). In the adjusted analysis, this was also the case for patients with MDA. This trend was also present for patients with sustained ASDAS inactive disease in DESIR; the difference between proportions was not as great as in EMBARK.

Conclusion:

These results are important because, for the first time, the data demonstrate a link between achieving sustained ASDAS inactive disease and MRI structural endpoints. The clinical relevance of change in MRI erosion and backfill in the SIJ and their relationship to the development of ankylosis requires further study.

Table. Patients in EMBARK with a decrease or increase in MRI structural lesion according to sustained ASDAS response type

Unadjusted analysis

Adjusted analysis*

Sustained ASDAS response type

Lesion decreased n/N (%)

Lesion increased n/N (%)

Net % patients with increase (95% CI)

P-value

Net % patients with increase (95% CI)

P-value

Erosion (Damage)

ASDAS inactive disease (<1.3)

Response

33/100 (33.0)

5/100 (5.0)

-28.0 (-38.8, -17.2)

<0.0001

-22.8 (-37.9, -7.7)

0.003

Non-response

9/50 (18.0)

2/50 (4.0)

-14.0 (-28.7, 0.7)

0.06

-17.1 (-34.9, 0.7)

0.06

ASDAS <2.1

Response

39/129 (30.2)

6/129 (4.7)

-25.6 (-35.0, -16.1)

<0.0001

-25.7 (-37.3, -14.0)

<0.0001

Non-response

3/21 (14.3)

1/21 (4.8)

-9.5 (-31.8, 12.7)

0.39

-8.4 (-35.8, 18.9)

0.53

Best sustained ASDAS response

Inactive disease

33/100 (33.0)

5/100 (5.0)

-28.0 (-38.8, -17.2)

<0.0001

-22.8 (-37.9, -7.7)

0.003

MDA (≥1.3 to <2.1)

6/29 (20.7)

1/29 (3.4)

-17.2 (-37.7, 3.3)

0.10

-41.6 (-69.5, -13.7)

0.005

Non-response

3/21 (14.3)

1/21 (4.8)

-9.5 (-31.5, 12.5)

0.39

-8.8 (-34.0, 16.3)

0.48

Backfill (Repair)

ASDAS inactive disease (<1.3)

Response

0/100 (0)

22/100 (22.0)

22.0 (13.9, 30.1)

<0.0001

19.5 (7.7, 31.3)

0.001

Non-response

1/50 (2.0)

3/50 (6.0)

4.0 (-5.0, 13.0)

0.38

8.1 (-3.4, 19.7)

0.17

ASDAS <2.1

Response

0/129 (0)

23/129 (17.8)

17.8 (11.3, 24.4)

<0.0001

17.0 (8.5, 25.5)

0.0001

Non-response

1/21 (4.8)

2/21 (9.5)

4.8 (-12.1, 21.7)

0.57

9.4 (-11.5, 30.4)

0.37

Best sustained ASDAS response

Inactive disease

0/100 (0)

22/100 (22.0)

22.0 (13.9, 30.1)

<0.0001

19.5 (7.7, 31.3)

0.001

MDA (≥1.3 to <2.1)

0/29 (0)

1/29 (3.4)

3.4 (-5.9, 12.8)

0.46

15.5 (0.4, 30.6)

0.04

Non-response

1/21 (4.8)

2/21 (9.5)

4.8 (-11.1, 20.6)

0.55

9.5 (-9.0, 28.0)

0.30

*Adjusted for covariates at baseline: sex, symptom duration, smoking status, human leukocyte antigen-B27 status, ASDAS, SPARCC MRI SIJ score, total SIJ score based on modified New York grade.

MDA, moderate disease activity.


Disclosure: W. P. Maksymowych, Abbvie, Pfizer, 2,Abbvie, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, 5; P. Claudepierre, Pfizer, Roche-Chugai, MSD, 2,Abbvie, BMS, Celgene, Janssen, Novartis, Merck, Pfizer, Roche, UCB, 5; M. de Hooge, MdH Research, 3; R. G. Lambert, BioClinica, 5,AbbVie, 8; R. B. M. Landewé, 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, 5,Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, and Wyeth, 2,Abbott/AbbVie, Amgen, Bristol Myers Squibb, Janssen (formerly Centocor), Merck, Pfizer, Roche, Schering-Plough, UCB, and Wyeth, 8; A. Molto, None; D. van der Heijde, AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCBAbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringe, 5,Director: Imaging Rheumatology bv, 9; J. F. Bukowski, Pfizer Inc, 1,Pfizer Inc, 3; H. Jones, Pfizer Inc, 1,Pfizer Inc, 3; I. Logeart, Pfizer Inc, 1,Pfizer Inc, 3; L. Marshall, Pfizer Inc, 1,Pfizer Inc, 3; R. Pedersen, Pfizer Inc, 1,Pfizer Inc, 3; A. Szumski, inVentiv Health, 3; B. Vlahos, Pfizer Inc, 1,Pfizer Inc, 3; M. Dougados, Pfizer, AbbVie, UCB, Merck and Lily, 2,Pfizer, AbbVie, UCB, Merck and Lily, 5.

To cite this abstract in AMA style:

Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewé RBM, Molto A, van der Heijde D, Bukowski JF, Jones H, Logeart I, Marshall L, Pedersen R, Szumski A, Vlahos B, Dougados M. Sustained Remission of Inflammation Is Associated with Reduced Structural Damage on SI Joint MRI in Patients with Early Axial Spa: Evidence to Support the Concept of Treat-to-Target [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/sustained-remission-of-inflammation-is-associated-with-reduced-structural-damage-on-si-joint-mri-in-patients-with-early-axial-spa-evidence-to-support-the-concept-of-treat-to-target/. Accessed .

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