FRI0245 Prospective follow-up of tocilizumab treatment in 1100 patients with refractory rheumatoid arthritis: tolerance data from the french registry regate (registry –roactemra)
Authors: J. Morel, M. O. Duzanski, A. Cantagrel, B. Combe, M. Dougados, R. M. Flipo, J. E. Gottenberg, X. Mariette, O. Vittecoq, A. Saraux, T. Schaeverbeke, T. Bardin, M. Soubrier, P. Ravaud, J. Siblia
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Objectives</h3> To assess safety and efficacy of rheumatoid arthritis (RA) treatment by tocilizumab (TCZ) in routine practice <h3>Methods</h3> The French Society of Rheumatology set up the REGATE registry to prospectively collect, every 6 months for 5 years, data from 1500 patients treated with TCZ for RA. From January 2011 to October 2012, 1100 patients treated by TCZ initiated after January 1st 2010 have been prospectively included from 78 French centres. Serious adverse events were collected <h3>Results</h3> Characteristics of patients: women: 80.2%, age 56.8±13.6 years, disease duration: 13.5 years ±9.9, number of prior DMARD: 2.5 ±1.5, DAS28: 5.1±1.4; 77% RF-positive, 77.9% ACPA positive), cancer (5.23%), severe infections (5.9%); current or past smoker (77%); history of cardiovascular event (19.1%); hypercholesterolémia (25%). Almost 10% of patients had not received any anti-TNF prior to TCZ and the number of biologics before TCZ was 2.1±1.5. The last biologic prescribed before initiation of TCZ was an anti-TNF for 59.7% of patients, rituximab for 16.8%, abatacept for 13.4%. TCZ was initiated 1.7 months (0-120) after last biologic. Before TCZ initiation, 69.6% of the patients received corticoids with a mean dose of 12 ± 34.3 mg/day. 39.1% of patients were treated with TCZ as monotherapy. 728 patients have already had at least 1 follow-up visit with a current follow-up duration of 40.8 ±26 months corresponding to an exposure of 568.1 patients/year (PY). After 1.9 years, 75% of RA patients were still treated with TCZ. Discontinuation was explained for 121 patients: 48 % for absence or loss of efficacy and 37% for safety reasons. Overall, 60 serious adverse events were reported: ten patients discontinued TCZ for infusion-reactions (2.3%). Forty one severe infections (14 soft tissues, 7 gastrointestinal, 7 articular, 8 respiratory tract and 2 urinary tract and 3 others site) were reported in 36 patients corresponding to a rate of severe infections of 7.2/100 PY. The other SAE were 3 gut perforations (0.5/100 PY), 2 lymphoma (0.4/100 PY), 1 skin cancer (0.2 /100 PY), 1 stroke (0.2/100 PY), 2 thrombo-embolic events (0.4/100PY) and 2 deaths. DAS28 scores were available for 172 and 230 patients at 7 and 14 ±1 monthsand low disease activity was respectively achieved for 60 and 67% of these patients <h3>Conclusions</h3> These preliminary results of the REGATE registry show that a high proportion of patients treated with TCZ was previously treated by anti-TNF (87%) even though it can be prescribed as a first line biologic. In addition, TCZ is not infrequently prescribed in monotherapy in clinical practice (39%). Severe infections are in the higher range observed with biologics but deserve to be confirmed after longer exposure duration. Low disease activity was achieved for one third of the patients in the first year of follow up <h3>Acknowledgements</h3> Club Rhumatisme et Inflammation for coordination and logistic supports Roche Chugaï laboratory for their financial support <b>Disclosure of Interest</b>: J. Morel Grant/research support from: Roche Chugaï, Consultant for: Roche Chugaï, M. O. Duzanski: None Declared, A. Cantagrel: None Declared, B. Combe: None Declared, M. Dougados: None Declared, R. M. Flipo: None Declared, J. E. Gottenberg: None Declared, X. Mariette: None Declared, O. Vittecoq: None Declared, A. Saraux: None Declared, T. Schaeverbeke: None Declared, T. Bardin: None Declared, M. Soubrier: None Declared, P. Ravaud: None Declared, J. Siblia: None Declared