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Abstract Number: 2764

Combination of Intra-Articular Steroid Injection and Tocilizumab More Effective Than Tocilizumab in Rapid Radiographic Progression Patients With Rheumatoid Arthritis. A Randomized, Open Label, x Ray Reader Blinded Study

Kensuke Kume1, Kanzo Amano1, Susumu Yamada1, Toshikatsu Kanazawa2, Hiroshi Komori3, Hiroyuki Ohta4, Noriko Kuwaba5 and Kazuhiko Hatta6, 1Rheumatology, Hiroshima Clinic, Hiroshima, Japan, 2rheumatology, hiroshima clinic, hiroshima, Japan, 3internal medicine, hiroshima clinic, hiroshima, Japan, 4Medical Research, hiroshima clinic, Hiroshima, Japan, 5Medical Research, Sanki Clinical Link, Hiroshima, Japan, 6Rheumatology, Hatta Clinic, Kure, Japan

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Steroids and tocilizumab

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Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy: Efficacy of Approved Biologics I

Session Type: Abstract Submissions (ACR)

Background/Purpose: Treatment of rheumatoid arthritis (RA) should aim at full remission. However, recent publications described rapid radiographic progression (RRP) existed despite initial biologics and methotrexate combination therapy in early RA. In RRP, initial biologics and methotrexate might be inadequate. We reported that infliximab plus intra-articular steroid injection is more effective than infliximab in RRP patients in RA. How about other biologics? To compare remission and radiographic non-progression in RRP patients treated with tocilizumab or with tocilizumab plus intra-articular steroid injection.

Methods: We designed a single-blind(X ray reader and assessment physician), randomized controlled trial. We screened 32 RRP (CRP> 35mg/L, RF +, and ACPA+) early (disease duration<6 months) RA patients for inclusion. 28 were randomly allocated tocilizumab group (T group) or tocilizumab plus intra-articular steroid injection group (T plus I group). All patients were taking methotrexate (from 12 to 22mg a week). For T plus I group, palpate examinations of both MP and PIP joints, wrists, elbows, shoulders, and knees were performed every 4 weeks. If swollen joints were existed, intra-articular steroid injections were intensified in each swollen joints by clinician’s decision. Co-primary endpoints were proportion of patients showing clinical remission (SDAI <3.3) and radiographic non-progression (Δ modified total Sharp score ≤0.5) at 52 weeks. Analysis was by intention-to-treat with last observation carried forward to missing data.

Results: The characteristics of each group at baseline were not significantly different.  Clinical remission at 52weeks was achieved by more patients in the T plus I group (42%) than in the T group (25%) (p<0.05). Radiographic non-progression at 52 weeks was achieved by more patients in the T plus I group (41%) than in the T group (18%) (p<0.05). Especially, swollen and tender joints counts at 52 weeks are significantly improved T plus I group(SJC: 3.6±1.3, TJC:4.2±2.1) than T group.(SJC: 8.5±4.2, TJC: 6.2±3.5)(p p<0.05). However C reactive protein at 52 is not significantly difference each group(T plus I group: 0.21±0.12 mg/L, T group: 0.26±0.22 mg/L)(p=0.67)

Conclusion: Results of this reveal that combination of intra-articular steroid injection and tocilizumab can achieve a high clinical and radiological remission rate in early RRP RA.

References:

1) Effectiveness of initial treatment allocation based on expert opinion for prevention of rapid radiographic progression in daily practice of an early RA cohort. Durnez A, et al. Ann Rheum Dis. 2011 Apr;70(4):634-7. Epub 2010 Dec 21.

2) A matrix risk model for the prediction of rapid radiographic progression in patients with rheumatoid arthritis receiving different dynamic treatment strategies: post hoc analyses from the BeSt study. Visser K, et al. Ann Rheum Dis. 2010 Jul;69(7):1333-7. Epub 2010 May 24.

3) A pilot risk model for the prediction of rapid radiographic progression in rheumatoid arthritis. Vastesaeger N, et al. Rheumatology (Oxford). 2009 Sep;48(9):1114-21. Epub 2009 Jul 9. Review.


Disclosure:

K. Kume,
None;

K. Amano,
None;

S. Yamada,
None;

T. Kanazawa,
None;

H. Komori,
None;

H. Ohta,
None;

N. Kuwaba,
None;

K. Hatta,
None.

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