ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2466

Long Term Efficacy Over Five Years Of Adalimumab In Patients With Active Non – Radiographic Axial Spondyloarthritis

Hildrun Haibel1, Xenofon Baraliakos2, Joachim Listing3, Juergen Braun4 and Joachim Sieper1, 1Charité Universitätsmedizin Berlin, Berlin, Germany, 2Rheumatology, Rheumazentrum Ruhrgebiet, Herne, Germany, 3German Rheumatism Research Center, Berlin, Germany, 4Rheumazentrum Ruhrgebiet, Herne, Germany

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Spondylarthropathies and Psoriatic Arthritis: Clinical Aspects and Treatment III

Session Type: Abstract Submissions (ACR)

Background/Purpose: Adalimumab had demonstrated good efficacy in 46 patients with active non-radiographic axial SpA in a 12-weeks, placebo-controlled trial with a 40-weeks, open-label extension.1,2In 19 patients who flared after drug withdrawal therapy was restarted and patients were followed-up. The purpose of the study was to evaluate the long term efficacy over 5 years after re-treatment with adalimumab in patients whose disease flared after treatment was stopped at week 52.

Methods: Of 46 patients originally enrolled, all patients were stopped and 23 (52% male; mean age 32 years [range 24-45]; mean disease duration before treatment 4 years [range 1-10]; 74% HLA-B27+) had reached a major response defined as reaching an 40% improvement according to the ASsessments in SpondyloArthritis international Society (ASAS40). In case of a flare (defined as  Results: 19 out of these 23 patients had to be retreated: 16/19 (84%) patients were still in the study at year 3 and 4. 12/19 (63%) patients completed year 5 of retreatment. After 3 years of adalimumab re-treatment, 13/16 (81%) again reached ASAS 40 and 11 of 16 (69%) achieved ASAS partial remission. After 4 years ASAS 40 was reached in 69% (11/ 16 patients) and after 5 years in 75% (9/ 12 patients). ASAS partial remission was reached in 56% (9/16) of patients after 4 years and in 58% (7/12) of patients at the end of year 5. The mean BASDAI for the completers at the different time points decreased from 5.1±1.8 at R-Baseline to 1.6±1.6 at year 3 (p < 0.001), to 2.2±2.1 at year 4 (p = 0.001) and 1.5±1.8 at year 5 (p = 0.001) of retreatment.

Conclusion: In this group of 19 patients with early axial SpA who had achieved a good response after 52 weeks of adalimumab therapy, and who had to be retrated because of a flare, the majority of patients who remained in the study had a good and sustained clinical response.

(1)   Haibel H, et al, A&R, 2008, 58(7):1981-91.

(2)   Haibel H et al, A&R, 2013 May 17.[epub ahead of print]

Disclosure:

H. Haibel,

AbbVie,MSD, Chugai,

8,

AbbVie, MSD,

5;

X. Baraliakos,

Janssen, MSD, Pfitz,er AVie, Chugai, Novartis,

2,

Janssen, MSD, Pfitz,er AVie, Chugai, Novartis,

5,

Janssen, MSD, Pfitz,er AVie, Chugai, Novartis,

8;

J. Listing,
None;

J. Braun,

AbbVie, Pfizer, MSD, UCB,

2,

AbbVie, Pfizer, MSD, UCB,

5,

AbbVie, Pfizer, MSD, UCB,

8;

J. Sieper,

AbbVie, Merck, Pfizer, UCB,

2,

AbbVie, Merck, Pfizer, UCB,

5,

AbbVie, Merck, Pfizer, UCB,

8.

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