THU0457 Comprehensive Disease Control with Less Relapse and Radiographic Progression at One Year by Intensive Therapy with Additional Short-Course of Tocilizumab: A Real-World, Prospective Cohort Study in Chinese Patients with Rheumatoid Arthritis
Authors: X.-Y. Wang, Y.-Q. Mo, J.-D. Ma, L.-F. Chen, J. Jing, D.-H. Zheng, L. Dai
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> 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. <h3>Objectives</h3> 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. <h3>Methods</h3> 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&lt;2.6, health assessment questionnaire (HAQ)&lt;0.5 and mTSS&lt;0.5. Relapse was defined as leaving DAS28 theraputic target corresponding to a DAS28(4)-ESR score of &gt;3.2. <h3>Results</h3> 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 (<i>p</i>&lt;0.05, Table 1), and there was no significant difference of other baseline characteristics and csDMARDs therapy during follow-up between two groups (all <i>p</i>&lt;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%, <i>p</i>=0.006), and the rates of patients reached therapeutic target (DAS28[4]-ESR&lt;3.2), remission (DAS28[4]-ESR&lt;2.6) or deep remission (DAS28[4]-ESR&lt;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%, <i>p</i>=0.010), consistent at week 24 (87% vs. 49%, <i>p</i>=0.002) and week 52 (70% vs. 43%, <i>p</i>=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 (<i>p</i>=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%, <i>p</i>&lt;0.05) and 52% patients in TCZ+csDMARDs group achieved CDC at week 52 which was significantly greater than those in csDMARDs group (24%, <i>p</i>=0.030). No significant difference of adverse events during follow-up was found between two groups (all <i>p</i>&lt;0.05). <h3>Conclusions</h3> 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. <h3>Acknowledgement</h3> 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). <h3>Disclosure of Interest</h3> None declared