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Abstract Number: 558

Major Reduction of Ultrasound Detected Synovitis during Subcutaneous Tocilizumab Treatment; Results from a Multicenter 24 Weeks Study of Patients with Rheumatoid Arthritis

Hilde B Hammer1, Inger Marie Jensen Hansen2, Pentti Järvinen3, Marjatta Leirisalo-Repo4, Michael Ziegelasch5, Birte Agular6 and Lene Terslev7, 1Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 2Rheumatology, Svendborg Hospital, Svendborg, Denmark, 3Rheumatology, Kiljava Medical Research, Kiljavan, Finland, 4Rheumatology, University of Helsinki, Helsinki, Finland, 5Rheumatology, University Hospital, Linköping, Linköping, Sweden, 6Roche, Copenhagen, Denmark, 7Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Doppler ultrasound, tocilizumab and ultrasound

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Session Information

Date: Sunday, October 21, 2018

Session Title: Rheumatoid Arthritis – Treatments Poster I: Strategy and Epidemiology

Session Type: ACR Poster Session A

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

Background/Purpose:

Ultrasound (US) is sensitive for detection of synovitis (assessed by Grey Scale (GS) and power/color Doppler). Presence of Doppler activity is found to predict erosive progression. Clinical disease activity in rheumatoid arthritis (RA) is usually evaluated by Composite Disease Activity Scores (CDAS) like CDAI, SDAI and DAS28. Treatment with subcutaneous tocilizumab (TCZ-SC), an IL-6 inhibitor, causes rapid fall in ESR and CRP. Thus, use of CDAS, which includes ESR or CRP, may not give correct information about the inflammatory activity, while this could potentially be better reflected by use of US. The present purpose was to explore the longitudinal response of TCZ-SC on US synovitis in comparison with CDAS in patients with RA.

Methods: This is a multi-country (Denmark, Finland, Norway, Sweden), open-label, single-arm study (part of TOZURA (1)), enrolling patients (pts) with inadequate response to csDMARDs. Pts received TCZ-SC 162 mg qw for 24 weeks as monotherapy or in combination with a csDMARD. Stable oral NSAIDs and corticosteroids (CS) (≤10 mg/day prednisone or equivalent), were allowed. US examination (36 joints and 4 tendons, scored according to the Norwegian US atlas (2)) and clinical (examinator’s and patient’s global VAS, 28 TJC, 28 SJC and ESR/CRP) were performed at baseline, 4, 12 and 24 weeks. Sum scores of GS/Doppler and CDAS were calculated, and remission by US (defined as sum score Doppler of 0, 1, 2 or 3) and CDAS (including Boolean) was explored.

Results:

110 pts were followed with US assessments (83% female, mean (SD) age 55.6 (12.1) years, RA duration 8.7 (9.5) years, 81% anti-CCP positive and 62% with erosive disease). Already after 4 weeks US, clinical variables and CDAS decreased significantly (p<0.001), and ESR/CRP reached normal levels (table 1). At 24 weeks, CDAI, SDAI and Boolean remission was found in 34.7%, 33.7% and 27.4%, while DAS28(ESR), being more influenced by low ESR, showed remission in 83.5%. US showed major reduction of synovitis after 24 weeks, where stringent Doppler remission criteria showed remission in more than half of the patients (sum score 0; 53.3%, 1; 65.6%, 2; 75.6% and 3; 78.9%).

Conclusion:

The different CDAS showed large discrepancies in number of patients in remission. US detected synovitis was markedly reduced with the initial effect seen already after 4 weeks, and with more than half of the patients achieving absence of Doppler activity after 24 weeks.

References

  1. EULAR 2017 Abstract SAT0199
  2. Hammer HB et al, ARD, 2011

Baseline

Median (IQR)

n=110

4 weeks

Median (IQR)

n=102

12 weeks

Median (IQR)

n=95

24 weeks

Median (IQR)

n=91

Sum score GS

21 (13-36)

16 (8-30)

12 (5-21)

9 (3-19)

Sum score PD

8 (2-20)

4 (1-10)

1 (0-4)

0 (0-2)

Tender joint count

8 (5-12)

4 (1-9)

2 (0-5)

1 (0-3)

Swollen joint count

6 (2-10)

2 (0.5-6)

1 (0-2.5)

0 (0-2)

Patient’s global VAS (0-100)

55 (36-70)

32 (18-49)

16 (7-31)

12 (4-28)

Assessor’s global VAS (0-100)

35 (25-49)

17 (11-31)

10 (5-18)

5 (2-11)

CRP (mg/L)

5.5 (2.6-13.1)

0.2 (0.2-0.4)

0.2 (0.2-0.6)

0.2 (0.2-0.4)

ESR (mm/h)

21 (12-34)

4 (2-7)

3 (2-5)

3 (2-5)

DAS28(ESR)

5.0 (4.3-5.8)

3.1 (2.1-3.8)

2.1 (1.5-2.9)

1.6 (1.1-2.4)

CDAI

23.8 (17.1-31.2)

12.9 (7.3-21.9)

7.2 (3.6-11.4)

4.3 (1.8-9.8)

SDAI

29.8 (21.1-45.0)

13.3 (7.6-23.2)

7.7 (3.8-12.6)

4.6 (2.2-10.2)


Disclosure: H. B. Hammer, AbbVie, Novartis, BMS, Pfizer, UCB, Roche, MSD, 8; I. M. J. Hansen, None; P. Järvinen, None; M. Leirisalo-Repo, None; M. Ziegelasch, AbbVie Inc., 8; B. Agular, Roche, 3; L. Terslev, Danish Rheumatism Association, 2, 8,AbbVie Inc., Roche, Novartis, 8.

To cite this abstract in AMA style:

Hammer HB, Hansen IMJ, Järvinen P, Leirisalo-Repo M, Ziegelasch M, Agular B, Terslev L. Major Reduction of Ultrasound Detected Synovitis during Subcutaneous Tocilizumab Treatment; Results from a Multicenter 24 Weeks Study of Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/major-reduction-of-ultrasound-detected-synovitis-during-subcutaneous-tocilizumab-treatment-results-from-a-multicenter-24-weeks-study-of-patients-with-rheumatoid-arthritis/. Accessed December 9, 2019.
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