Background To analyze efficacy and safety of tocilizumab in patients with rheumatoid arthritis (RA) and an inadequate response to conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) and/or tumour necrosis factor (TNF) inhibitors of the Swiss and Austrian patients from the ACT-SURE study.
Methods Sub-analysis of RA patients from Switzerland and Austria, who participated in the international phase IIIb, open-label, ACT-SURE study. Patients with an inadequate response to csDMARDs or TNF antagonists were included into the study receiving 8 mg/kg of IV tocilizumab every 4 weeks during a 24 week time period. Therapy with one or more csDMARDs could be continued as combination therapy with tocilizumab (Combo) or stopped, resulting in tocilizumab monotherapy (Mono), at the treating physician's discretion. These two patient groups were analyzed in separate and compared.
Results Overall, 107 (22 on Mono vs 85 on Combo and) patients were treated with tocilizumab. The percentage of patients with at least one adverse event was significantly lower in the tocilizumab combination (58.8%) as compared to the monotherapy group (81.8%, p=0.0458). No differences in ACR20/50/70/90 response rates were observed between both treatment groups at week 24 (Mono: 63.6%, 40.9%, 22.7%, and 18.2% vs. Combo: 61.2%, 43.5%, 25.9%, and 10.6%). The median time to low disease activity (LDA) was significantly shorter in patients treated with tocilizumab combination therapy Mono: 9.1, Combo 7.9 weeks, Log Rank p=0.038).
Conclusions In this post hoc regional sub-analysis of the ACT-SURE study no differences for disease activity were found comparing the two patient groups at week 24. However, median time to LDA was statistically shorter in patients treated with tocilizumab combination therapy as compared to tocilizumab monotherapy. Consequently, adding tocilizumab to csDMARD therapy rather than changing to tocilizumab monotherapy may be, in our opinion, the safest strategy to reach maximum effect in RA patients with active disease despite treatment with csDMARD. csDMARDs can be withdrawn either immediately due to adverse events or after at least low disease activity has been reached.
Disclosure of Interest None declared
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