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Abstract Number: 562

Clinical Response and Remission in Patients with Non-Radiographic Axial Spondyloarthritis after Three Years of Adalimumab Therapy

Désirée M. van der Heijde1, Joachim Sieper2, Walter P. Maksymowych3, Dominique L. Baeten4, Yinglin Xia5, Jaclyn K. Anderson5 and Aileen L. Pangan5, 1Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 2Charité Universitätsmedizin Berlin, Berlin, Germany, 3Department of Medicine, University of Alberta, Edmonton, AB, Canada, 4Department of Clinical Immunology and Rheumatology and Department of Experimental Immunology, Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands, 5AbbVie Inc., North Chicago, IL

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Adalimumab, axial spondyloarthritis, non-radiographic, remission and safety

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Session Information

Title: Spondyloarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment I

Session Type: Abstract Submissions (ACR)

Background/Purpose:

Adalimumab (ADA) has been previously shown to be effective for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) patients (pts) in the ABILITY-1 trial.1 Week (wk) 12 results were further supported by sustained clinical response and remission data through Year 2 of the study.2 We evaluate the final Year 3 long-term response/remission and durability of response with ADA in pts with nr-axSpA. 

Methods:

ABILITY-1 was a phase 3, double blind (DB), randomized, controlled trial in pts with nr-axSpA who had an inadequate response, intolerance, or contraindication to NSAIDs. A 12-wk DB period of ADA 40 mg every other week (eow) or placebo was followed by an open-label period in which pts could receive ADA 40 mg eow for up to an additional 144 wks. This post hoc analysis evaluated the final Year 3 (wk 156) efficacy and safety results for both the overall population and the MRI+/elevated CRP sub-population defined as those with a positive MRI at baseline (BL) (SPARCC score ≥2 for either the SI joints or spine) or an elevated CRP at BL. ASAS, BASDAI and ASDAS responses were calculated. Clinical remission was defined by ASDAS inactive disease (ASDAS ID, ASDAS <1.3) or by ASAS partial remission (ASAS PR).

Results:

Of the 185 pts enrolled in ABILITY-1, 122 (66%) had data available at wk 156 and 97 of 142 (68%) from the MRI+/elevated CRP sub-population. Clinical responses and remission rates were generally sustained between Year 2 and Year 3 of the study (Table). Through 412.2 patient-years (PYs) of exposure to ADA, the serious infection rate observed was 2.4 events/100 PYs, including 1 case of disseminated TB. There were 2 deaths – 1 due to suicide and another due to opiate toxicity. There were no malignancies reported.

Table. Long-term clinical response and remission at Years 2 and 3

%

Overall Population

MRI+/elevated CRP Sub-population

Year 2

Year 3

Year 2

Year 3

NRI

N=185

Observed

Data

N=138

NRI

N=185

Observed Data

N=122

NRI

N=185

Observed Data

N=107

NRI

N=185

Observed Data

N=97

ASAS20

61

81

55

83

62

82

58

86

ASAS40

48

64

44

66

50

66

47

69

ASAS PR

28

39 a

28

43 d

32

44 f

32

47 i

BASDAI50

49

65

46

70

52

69

49

72

ASDAS CII

49

69 b

44

69 e

56

77 g

48

73 j

ASDAS MI

27

38 b

25

40 e

30

41 g

27

42 j

ASDAS ID

34

46 c

30

46 d

36

49 h

32

47 k

aN=135; bN=131; cN=136; dN=120; eN=118; fN=104; gN=103; hN=105; iN=96; jN=93; kN=95.

ASAS, Assessment of SpondyloArthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CII, clinically important improvement; ID, inactive disease; MI, major improvement; NRI, non-responder imputation; PR, partial remission. 

Conclusion:

Almost half of the pts who remained on long-term ADA therapy in ABILITY-1 were in remission at the end of the study (Year 3), whether measured by ASAS PR or ASDAS ID. Results were similar between the overall population and the MRI+/elevated CRP sub-population.

References:

  1. Sieper J et al. Ann Rheum Dis 2013;72:815–22.
  2. Sieper J et al. Ann Rheum Dis 2013;72(Suppl3):88.

Disclosure:

D. M. van der Heijde,

AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Covagen, Daiichi, Eli Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, Vertex,

2,

AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Covagen, Daiichi, Eli Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, Vertex,

5,

Imaging Rheumatology BV,

9;

J. Sieper,

AbbVie, Merck, Pfizer, UCB,

2,

AbbVie, Merck, Pfizer, UCB,

5,

AbbVie, Merck, Pfizer, UCB,

8;

W. P. Maksymowych,

from AbbVie, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, UCB,

2,

from AbbVie, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, UCB,

5,

CaRE Arthritis,

9;

D. L. Baeten,

AbbVie, BMS, Boehringer Ingelheim, Centocor, Janssen, MSD, Novartis, Pfizer, UCB,

2,

AbbVie, BMS, Boehringer Ingelheim, Centocor, Janssen, MSD, Novartis, Pfizer, UCB,

5,

AbbVie, BMS, Boehringer Ingelheim, Centocor, Janssen, MSD, Novartis, Pfizer, UCB,

8;

Y. Xia,

AbbVie,

1,

AbbVie,

3;

J. K. Anderson,

AbbVie,

1,

AbbVie,

3;

A. L. Pangan,

AbbVie,

1,

AbbVie,

3.

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