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Abstract
Background Tocilizumab (TCZ) was the first approved non-TNFα bDMARD for rheumatoid arthritis (RA) in China since November 2013. However, the mean course of TCZ for most Chinese RA patients is about 3–6 months because of self-paid and expensive price, similar to the situation of other biological originator DMARDs or their biosimilar.
Objectives To investigate the efficacy and safety of additional short-course of TCZ combined with csDMARDs on disease activity and 1-year radiographic progression of RA patients.
Methods One hundred and ten RA patients with moderate to high disease activity were treated with csDMARDs and followed up regularly at baseline, week 4, 12, 24 and 52. Thirty-seven of them were willing to receive additional 3–6 consecutive doses of intravenous TCZ 8 mg/kg every 4 weeks. One-year radiographic progression was defined as mTSS≥0.5. Comprehensive disease control (CDC) was defined as DAS28(4)-CRP<2.6, health assessment questionnaire (HAQ)<0.5 and mTSS<0.5. Relapse was defined as leaving DAS28 theraputic target corresponding to a DAS28(4)-ESR score of >3.2.
Results Seventy-four RA patients who have finished 52 weeks follow-up were qualified for statistics. Patients in TCZ+csDMARDs group (n=23) were with significant higher disease activity by DAS28(4)-ESR than those in csDMARDs group (n=51) at baseline (p<0.05, Table 1), and there was no significant difference of other baseline characteristics and csDMARDs therapy during follow-up between two groups (all p<0.05). There was 35% patients in TCZ+csDMARDs group reached remission at week 4 which was significantly greater than those in csDMARDs group (8%, p=0.006), and the rates of patients reached therapeutic target (DAS28[4]-ESR<3.2), remission (DAS28[4]-ESR<2.6) or deep remission (DAS28[4]-ESR<1.98) at week 12 in TCZ+csDMARDs group were also significantly higher (Fig. 1). The ratio of patients with EULAR good response at week 12 in TCZ+csDMARDs group was significantly higher than that in csDMARDs group (74% vs. 35%, p=0.010), consistent at week 24 (87% vs. 49%, p=0.002) and week 52 (70% vs. 43%, p=0.046). For patients who have reached therapeutic target during follow-up, 65% (22/34) of them in csDMARDs group and 33% (7/21) in TCZ+csDMARDs group relapsed within 52 weeks (p=0.029).The one-year radiographic progression rate at week 52 in TCZ+csDMARDs group was significantly lower than those in csDMARDs group (13% vs. 49%, p<0.05) and 52% patients in TCZ+csDMARDs group achieved CDC at week 52 which was significantly greater than those in csDMARDs group (24%, p=0.030). No significant difference of adverse events during follow-up was found between two groups (all p<0.05).
Conclusions Intensive therapy with additional short-course of TCZ combined with csDMARDs could induce more CDC with less relapse and radiographic progression at one year which implies an alternative cost-effective strategy of biologics for RA patients especially in developing countries.
Acknowledgement This work was supported by National Natural Science Foundation of China (81471597), Specialized Research Fund for the Doctoral Program of Higher Education (20130171110075) and Guangdong Natural Science Foundation (2014A030313074).
Disclosure of Interest None declared