Background/Purpose:

Rheumatoid arthritis (RA) patients with anti-citrullinated peptide antibodies (ACPA) need a more aggressive therapy (1). Tocilizumab (TCZ) seems to be the biologic with best response rates when used in monotherapy. It is unclear whether therapeutic response to TCZ monotherapy or TCZ plus methotrexate (MTX) is influenced by ACPA status.

Methods:

Statistical analyses were performed with data from the OPTIMISE trial (EUDRACT No. 2011-001863-39) running in Austria from January 2012 to August 2013. Seventy-six patients with mild to moderate RA and inadequate response (DAS28 >2.6 and ≤4.5) to a stable MTX dose (15 – 25 mg/wk) were enrolled and received three infusions of TCZ (8 mg/kg) iv every 4 weeks + MTX. Patients achieving good or moderate EULAR response at week 12 (n = 65) were randomized into Group A (TCZ 8 mg/kg plus MTX) or Group B (TCZ 8 mg/kg plus MTX placebo). Every four weeks disease activity was estimated with DAS28 (Disease Activity Score with 28 joint counts), SDAI (Simplified Disease Activity Index), CDAI (Clinical Disease Activity Index) and RADAI-5 (Rheumatoid Arthritis Disease Activity Index 5). In both groups patients were assigned to the anti-CCP-positive or -negative group. Group A included 17 patients anti-CCP-positive and 13 patients anti-CCP-negative; Group B 19 patients anti-CCP-positive and 14 patients anti-CCP-negative. Statistical comparisons analyzed three time points (week 0, baseline; week 12, end of therapy TCZ plus MTX and week 24, end of TCZ plus MTX or TCZ plus MTX placebo).

Results:

In the anti-CCP-positive and the anti-CCP-negative group DAS28, CDAI, SDAI and RADAI-5 changed significantly (p<0.001) from baseline to week 12, but did not change from week 12 to week 24. Between-group comparison revealed no significant difference in any disease activity marker at any time point.

Conclusion:

In the anti-CCP-positive and the anti-CCP-negative group DAS28, CDAI, SDAI and RADAI-5 changed significantly (p<0.001) from baseline to week 12, but did not change from week 12 to week 24. Between-group comparison revealed no significant difference in any disease activity marker at any time point.

Literature

1. In the anti-CCP-positive and the anti-CCP-negative group DAS28, CDAI, SDAI and RADAI-5 changed significantly (p<0.001) from baseline to week 12, but did not change from week 12 to week 24. Between-group comparison revealed no significant difference in any disease activity marker at any time point.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-tocilizumab-monotherapy-in-patients-with-ra-is-not-influenced-by-acpa-positivity/