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AB0521 A single-arm, open-label study of the safety and effectiveness of tocilizumab in combination with methotrexate, in patients with rheumatoid arthritis in latin america – preliminary effectiveness results-ritmo study
  1. C. Zerbini1,
  2. J. Orozco2,
  3. M. Martinez3,
  4. J. Jaller4,
  5. A. Quinteros5,
  6. Y. Finol6,
  7. J. Facal7,
  8. R. Villacís8,
  9. J. Alfaro9,
  10. P. Faustino10,
  11. R. Sáenz11
  1. 1Cepic, Sao Paulo, Brazil
  2. 2Rheumatology, Mexico City, Mexico
  3. 3Pontificia Univer.Catolica, Santiago, Chile
  4. 4C.Reumatol., Barranquila, Colombia
  5. 5C.Integral Reumatol., S.Miguel de Tucumán, Argentina
  6. 6H.U.Dr.Antonio M.Pineda, Barquisimeto, Venezuela, Bolivarian Republic Of
  7. 7H.Maciel, Montevideo, Uruguay
  8. 8Novaclin.Sta Cecilia, Quito, Ecuador
  9. 9C.Rehab.Física, Lima, Peru
  10. 10Roche, Sao Paulo, Brazil
  11. 11C.Especial.Medicas, Heredia, Costa Rica

Abstract

Objectives To present the preliminary effectiveness data of TCZ + MTX treatment, with regard to reduction in signs and symptoms over 6 months in Latin American pts with mod/severe RA, MTX-IR.

Methods Ritmo is a single-arm, open-label, prospective study, performed at 69 sites (18 Brazil, 12 Colombia, 9 Chile, 7 Mexico, 6 Argentina, 5 Ecuador, 4 Peru, 4 Costa Rica, 3 Venezuela, 1 Uruguay). Pts received TCZ 8 mg/kg IV/4wks + MTX(10-25mg/wk). Endpoints at wk24 included proportion of pts with ACR20/50/70 and DAS28 <2.6, change in DAS28, EULAR resp. and HAQ. Clinical instructions (e.g.AES handling) were similar to the ones in Phase III trials.

Results 362 patients were included (ITT). Mean age was 51 yrs, 88% women, with mean disease duration of 11yrs. RF positive in 79% of pts. Mean±SD Baseline DAS28 was 6.45±1.0 and mean±SD HAQ-DI score 1.55±0.7. 319 pts (88%) completed the 24wk treatment. At wk24, 63% of pts (95% CI: [57.9; 68,3]) had achieved the primary objective (ACR50). ACR20/70 rates were 72.6% (95% CI: [67.6; 77.2]) and 20.8% (95% CI: [16.7; 25.5]), respectively. DAS28 <2.6 was achieved by 54.4% of pts. Mean±SD change in DAS28 score was 3.9±1.43 (p<0.0001). Good and moderate EULAR responses were observed in 73.3% and 24.3% of pts, respectively. Mean±SD change in HAQ-DI was 0.92±0.7 (p<0.0001). TCZ safety profile was comparable to that previously observed.

Figure 1: ACR 20/50/70 responses over 24 weeks.

Conclusions At wk24, significant improvement was observed and the safety profile of TCZ was comparable to that previously observed. These results suggest that TCZ is a therapeutic option in our region as suggested by data from the Pivotal Trials in DMARD-IR population.1-3

  1. Smolen J, et al. Lancet 2008; 371:987-97.

  2. Genovese M, et al. Arthritis Rheum 2008; 58:2968-80.

  3. Kremer et al. Arthritis Rheum 2011;63(3):609-21.

Disclosure of Interest C. Zerbini Grant/Research support from: Roche, Jansen, Pfizer, Sanofi-Aventis, J. Orozco Grant/Research support from: Roche, M. Martinez Grant/Research support from: Roche, J. Jaller Grant/Research support from: Roche, A. Quinteros Grant/Research support from: Roche, Y. Finol: None Declared, J. Facal: None Declared, R. Villacís: None Declared, J. Alfaro: None Declared, P. Faustino Employee of: Roche, R. Sáenz: None Declared

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