THU0212 Improved Remission Rates Acquired by Adding Adalimumab to Methotrexate and Intraarticular Glucocorticoid Cannot be Maintained after Withdrawal of Adalimumab. A 2-Year Investigator Initiated Randomised, Controlled Study on Early Rheumatoid Arthritis

Background

Recently we reported, that DAS28CRP<3,2 was achieved in more than 75% of early (< 6 months duration), treatment naïve rheumatoid arthritis (ERA) patients using methotrexate (MTX) + intraarticular (i.a.) triamcinolone (TRIAM) and in case of inadequate response after the 3^rd month triple therapy with MTX, sulphasalazine (SZS) and hydroxychloroquine (HCQ)¹. Addition of adalimumab (ADA) at baseline yielded even better clinical responses and remission rates after treatment for one year.

Objectives

The purpose of the present investigation was to study whether the improved clinical response obtained by adding ADA to MTX + i.a. TRIAM injections can be maintained after withdrawal of ADA.

Methods

Patients with ERA were randomized to receive i.a. TRIAM (40 mg/ml) in any swollen joint in combination with MTX (20 mg/wk) for two years and placebo-ADA (MTX+PLA) or MTX+ADA (40 mg eow) during the first year. Peroral glucocorticoid was not allowed. After 1 yr, ADA/PLA was withdrawn. If patients had swollen joints and DAS28(CRP)>3.2 during yr 2, SZS and HCQ were added, and if active disease persisted, ADA (40 mg eow) replaced SZS and HCQ in both treatment arms. Clinical response was assessed by DAS28(CRP), CDAI, SDAI and ACR/EULAR remission criteria. Analysis was by ITT with last observation carried forward. Medians (5%/95% percentiles) or percentage. Mann-Whitney or Pearson’s chi-square tests.

Results

Baseline characteristics were similar in the MTX+PLA and MTX+ADA groups (DAS28(CRP) 5.6 (3.8-7.3) vs. 5.5 (3.8-7.8), NS). Table shows 1 and 2 years results. Serious adverse events were seen in 10 MTX+PLA patients (malignancy: 2, infections: 5, other: 2) and in 16 MTX+ADA patients (malignancy: 3, infections: 5, other: 8).

Conclusions

Combined MTX and i.a. TRIAM provided excellent disease control at 2 years’ follow-up of ERA patients. The improved clinical responses observed during additional ADA administration could not be maintained after withdrawal of ADA. Radiographic data are needed to evaluate the overall effect of 1 yr of ADA as induction therapy in combination with MTX and i.a. TRIAM in ERA

References

Hørslev-Petersen K et al. Ann Rheum Dis 2012:

Disclosure of Interest

None Declared