AB0340 Tapering Strategy in Patients with Rheumatoid Arthritis Receiving Tocilizumab
Authors: C. Tornero, C. Plasencia, D. Pascual, T. Jurado, I. Monjo, M.B. Paredes, E. Moral, A. Pieren, L. Nuño, G. Bonilla, D. Peitedo, E.M. Mola, A. Balsa
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> Clinical trials have demonstrated the efficacy of Tocilizumab (TCZ) for patients with rheumatoid arthritis (RA). Several studies have demonstrated that dose tapering of TNF-inhibitors is a feasible therapeutic option in rheumatic patients with low disease activity (LDA). Nevertheless, few reports analyse the effectiveness of dose-tapering of TCZ. <h3>Objectives</h3> To evaluate the clinical outcome and incidence of flares in patients with RA in remission or LDA under a tapering strategy with TCZ and to analyse the influence of the tapering on serum drug levels. <h3>Methods</h3> Of a cohort of 34 adult patients with RA under therapy with TCZ, 13 patients with sustained LDA or remission (DAS 28-ESR &lt;3,2) under a tapering strategy were included. Clinical disease activity (DAS-28-ESR, CDAI and SDAI), serological data (C-reactive protein, erythrocyte sedimentation rate) and serum TCZ levels were evaluated at the visit prior to starting tapering strategy (V0) and at the last visit available during a three-year follow-up period (LV). The tapering strategy consisted in a progressive interval prolongation and/or dose reduction. A flare was defined as an increase of the DAS28 greater than 3.2 plus a delta-DAS28 (related to pre-tapering DAS28) lower than -0.6. The number of flares, time to first flare and the activity in the worst flare were collected. In the case of a flare, the concomitant therapy and TCZ dose could be intensified. Blood samples were collected just before the infusion and serum drug levels were measured by ELISA. <h3>Results</h3> The baseline demographic and clinical characteristics are shown in Table 1. No differences in the clinical activity (DAS28: 2,28± 0,8 at V0 vs 2,5±0,7 at LV, p=0,25; CDAI 4,71: ±5,1 at V0 vs 5,71±5,1 at LV p=0,08; SDAI (4,99±5,3 at V0 vs 5,0 ±4,8 at LV, p=0,052), number of swollen joints (1,69±3,2 at V0 vs 1,46±1,8 at LV; p=0,091) and tender joints (0,69± 1,1 at V0 vs 0,62±0,96 at LV; p=0,243) and acute-phase reactants (CRP: 0,48±0,6 at V0 vs 0,54±0,6 at LV, p=0,219; ESR: 7,69±3,1 at V0 vs 10,3±5,4 at LV, p=0,152) between V0 and LV were observed. The decrease of drug levels between V0 and LV was not significant (15,4±9,31 vs 3,02±5,99, p=0,867). During the follow-up period, 6 (43%) patients presented flares. The number of flares after the tapering strategy was 1,2±1,6 and the time to the first flare was 1±0,4 years. The following clinical and disease activity data and serum TCZ levels were registered at the worst flare: STJ: 6,7± 7,4 and TJC: 1,83±1,2; DAS28: 3,99±0,6, CDAI: 14,7± 8,2 and SDAI: 14,5±9,08; TCZ levels: 0,86±1,78. Most patients after having a flare (4/6) reached remission or LDA at the end of the study, and no significant differences in LDA were observed between those with or without flares (DAS-28 LV&lt;3,2:4/11 (36,4%) vs 7/11 (63,6%), p=0,097; CDAI LV &lt;10: 4/10 (66,7%) vs 6/10 (85,7%), p=0,42; SDAI LV &lt;11: 4/11 (36,4%) vs 7/11 (63,6%), p=0,097, respectively). All of the patients continued on tapering strategy and no patients dropped out because of inefficacy. <h3>Conclusions</h3> The tapering strategy in patients with RA with LDA or remission receiving TCZ appears to be feasible, resulting in a low proportion of patients with flares and a good longterm clinical disease activity control. <h3>Disclosure of Interest</h3> C. Tornero Grant/research support from: Funded by an unrestricted medical grant from Pfizer., C. Plasencia: None declared, D. Pascual: None declared, T. Jurado: None declared, I. Monjo: None declared, M. B. Paredes: None declared, E. Moral: None declared, A. Pieren: None declared, L. Nuño: None declared, G. Bonilla: None declared, D. Peitedo: None declared, E. M.Mola: None declared, A. Balsa: None declared