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

Kensuke Kume¹, Kanzo Amano¹, Susumu Yamada¹, Kazuhiko Hatta², Kuniki Amano³, Hiroyuki Ohta⁴ and Noriko Kuwaba⁵, ¹Rheumatology, Hiroshima Clinic, Hiroshima, Japan, ²Rheumatology, Hatta Clinic, Kure, Japan, ³Rheumatology, Sky Clinic, Hiroshima, Japan, ⁴Medical Research, hiroshima clinic, Hiroshima, Japan, ⁵Medical Research, Sanki Clinical Link, Hiroshima, Japan

Meeting: ACR/ARHP Annual Meeting 2012

Keywords: Infection, infliximab and rheumatoid arthritis (RA)

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy

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.To compare remission and radiographic non-progression in RRP patients treated with infliximab or with infliximab plus intra-articular steroid injection.

Methods: We designed a single-blind(X ray reader and assessment physician), randomized controlled trial. We screened 48 RRP (CRP> 35mg/L, RF +, and ACPA+) early (disease duration<6 months) RA patients for inclusion. 39 were randomly allocated infliximab group (I group) or infliximab plus intra-articular steroid injection group (I plus I group). All patients were taking methotrexate (from 14 to 22mg a week). For I 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. 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 I plus I group (32%) than in the I group (19%) (p<0.05). Radiographic non-progression at 52 weeks was achieved by more patients in the I plus I group (37%) than in the C group (24%) (p<0.05).

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

Disclosure:

K. Kume,
None;

K. Amano,
None;

S. Yamada,
None;

K. Hatta,
None;

K. Amano,
None;

H. Ohta,
None;

N. Kuwaba,
None.

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