Background Methotrexate (MTX) is the cornerstone of the treatment for rheumatoid arthritis (RA) as an “anchor” drug, and it is often used concomitantly with biologics. There are many reports of the concomitant use of MTX with a biologics resulting in increased efficacy, particularly with TNF inhibitors. It has been shown in clinical trials that, in bio-naive RA patients treated with TCZ, whether or not MTX is used concomitantly makes no difference in the outcome. However, there have so far been few reports that have directly compared the patients treated with and without the combination in clinical practice.
Objectives The aim of this study was to compare a group of bio-naive RA patients receiving TCZ with concomitant MTX to a group being treated without concomitant MTX in the clinical setting.
Methods The study was conducted in 39 bio-naive RA patients being treated with TCZ; 22 of these patients were not receiving concomitant MTX (the monotherapy group: M group) and 17 were receiving concomitant MTX (the combination therapy group: C group). At baseline, and after six and 12 months, the following parameters were investigated: CRP, ESR, swollen joints count (SJC), tender joints count (TJC), MMP-3, DAS28-ESR, DAS28-CRP and adverse events.
Results In the baseline comparison, the non-MTX group had significantly higher DAS28-ESR scores (M group mean: 5.4 [3.4-8.3]; C group mean: 5.0 [3.1-6.2]). After six months, the mean number of swollen joints was 3.0 (0-8) in the M group and 1.2 (0-7) in the C group, the mean number of tender joints was 2.2 (0-7) in the M group and 0.7 (0-4) in the C group, the mean DAS28-ESR was 3.2 (1.4-5.2) in the M group and 2.4 (0.7-3.5) in the C group, and the mean DAS28-CRP was 2.4 (1.5-3.8) in the M group and 1.7 (1.2-2.9) in the C group. Therefore, each of these scores improved significantly more in subjects receiving concomitant MTX than in subjects not receiving concomitant MTX. After 12 months of treatment, the mean number of tender joints was 1.5 (0-1) in the M group and 0.4 (0-1) in the C group and the mean DAS28-CRP was 2.2 (1.2-3.6) and 1.6 (1.2-2.5) in the M and C groups, respectively. Therefore, after 12 months, the C group exhibited significantly better improvement than the M group, but only in these two parameters. No differences were found between the groups in terms of adverse events.
Conclusions In this study, the C group showed significantly inhibited disease activity at both six and 12 months, suggesting that MTX should be used concomitantly with TCZ whenever possible. The improvement was demonstrated as early as six months, thus suggesting that patients who concomitantly receive MTX can achieve an improvement in the disease activity sooner than patients who do not concomitantly receive MTX.
Dougados M, Kissel K, Sheeran T, et al. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis. 2013 Jan;72(1):43-50
Disclosure of Interest None Declared
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