Background Tocilizumab (TCZ) was highly effective in numerous RCT. There are much les data from registries, which can bring additional data about efficacy and safety in real clinical practise. Predictive factors of response to TCZ are los not completely understood.
Objectives To estimate efficacy and safety of tocilizumab (TCZ) in real clinical practise. To evaluate clinical and laboratory predictors for achieving low disease activity (LDA) in 6 and 12 months. To compare efficacy and safety of monotherapy with TCZ and combination of TCZ plus DMARD.
Methods All patients were included in obligatory, nation wide- registry of biologic therapy ATTRA. They fulfilled criteria of national society for initiation of biologic therapy: at least failure of 1 DMARD, DAS 28 (ESR) higher than 3,9, Measured outcomes: DAS 28 (ESR, CRP), HAQ, LDA (DAS 28 lower than 3,2), remission (DAS 28 lower than 2,6). Univarate and multivariate regression analysis was used to calculate OR for achieving LDA.
Results Altogether 151 patients were included in the study. The mean age of the patients was 49 years, duration of disease 11 years, CRP 24,1 mg/l, DAS 28 CRP 5,9, DAS 28 ESR 6,3 and HAQ 1,8. Survival on therapy was 88 % after 6 months and 75 % after 12 months in TCZ plus DMARD group and 85 % and 85 % in monotherapy group. EULAR response was achieved after 6 and 12 months in 94 % and 88 %, LDA in 73 % and 67 % and remission in 55 % and 48 %. The differences between mono and combi-therapy in achieving LDA were not significant (73 % in mono and 62 % in combi, p = 0,735). The only significant factor for prediction of achieving LDA at 12 months was number of swollen joints (SJ) at baseline. The patients with 9 and more SJ had lower chance of achieving LDA (p = 0,0021, OR = 0,08 /0,01, 0,69). Sensitivity of this model was 72 % and specificity 100 %. Positive predictive value was 100 %, negative 62,2 %. Age, duration of disease, number of previous DMARD, concomitant prednison, concomitant MTX, CRP, DAS 28 CRP, DAS 28 ESR were not predictive for achieving LDA. The incidence of adverse events was 29,2 % and of serious adverse events 6,7 % with no differences between the combi and monotherapy group
Conclusions Tocilizumab was highly effective in treatment of active, longstanding refractory RA in national registry. LDA was achieved in 2/3 of patients and remission in ½ patients after 12 months. There were no differences in efficacy and safety between monotherapy with TCZ and combination therapy TCZ plus DMARD. The only predictive factor for achieving LDA was number of swollen joints.
Acknowledgements Key words: rheumatoid arthritis, tocilizumab, prediction of response
Supported by grant of ministry of Health. Nr. NT12437
Disclosure of Interest K. Pavelka Grant/research support from: Ministry of Health Czech Republic Nr. NT12437, K. Hejduk: None Declared, H. Mann: None Declared, E. Dokoupilova: None Declared, D. Suchy: None Declared