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• W2327551490 abstract "Background A significant number of RA patients (pts) have low haemoglobin (Hb) levels. Normalisation of Hb in anaemic RA pts may be a suitable marker of improvement in disease activity, as well as improvement of fatigue. Objectives The main objective of this phase IIIb, national, multicentric, open-label, prospective, single-arm study was to assess the effects of TCZ in combination with DMARDs on anaemia and fatigue over 24 weeks of treatment in pts with moderate-severe active RA who had an inadequate response to DMARDs. Methods TCZ 8mg/kg IV was given every 4 wks for a total of 6 infusions. Changes from baseline of anemia and fatigue at wk 4, evaluated as change in Hb levels and FACIT-Fatigue questionnaire, respectively, were the primary endpoints. Secondary efficacy endpoints were measured up to 24 wks from the start of treatment. Adverse events (AEs) and lab tests were the safety measures. Paired t test was used for the analysis of changes from baseline. Results A total of 105 pts (mean age 55 years, 85% females) received TCZ (ITT population) and 13 (12.4%) were discontinued (AEs was the leading cause of withdrawal, 7 pts). Mean (±SD) Hb levels and FACIT-Fatigue score significantly increased from baseline to wk 4 (+0.40±0.78 g/dl and +8.76±8.83, respectively, p Conclusions A 24-wk treatment with TCZ 8mg/kg in combination with DMARDs in pts with moderate-severe active RA not responsive to DMARDs therapy was associated with rapid and sustained improvements of anaemia and fatigue, and good clinical response rates with the safety profile of TCZ consistent with that previously reported. Disclosure of Interest R. Foti: None Declared, R. Russo: None Declared, N. Malavolta: None Declared, E. Bravi: None Declared, A. Semeraro: None Declared, M. Limonta: None Declared, M. Muratore: None Declared, M. R. Pozzi: None Declared, M. Spinello: None Declared, M. C. Bernardoni: None Declared, F. Versace: None Declared, V. Rogai Employee of: Roche S.p.a." @default.
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• W2327551490 date "2013-06-01" @default.
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• W2327551490 title "AB0569 Effects of tocilizumab in combination with non biologic DMARDS on early improvement of anemia and fatigue in adult patients with moderate to severe active rheumatoid arthritis" @default.
• W2327551490 doi "https://doi.org/10.1136/annrheumdis-2012-eular.569" @default.
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