José M Álvaro-Gracia1, Antonio Fernández-Nebro2, Alicia García-López3, Manuel Guzmán4, Francisco J Blanco5, Francisco J Navarro6, Sagrario Bustabad7, Yolanda Armendáriz8, José A Román-Ivorra9. 1. Servicio de Reumatología, Unidad de Terapias Biológicas, Hospital Universitario de La Princesa, Madrid, España. Electronic address: jalvarogracia@gmail.com. 2. Servicio de Reumatología, Hospital Regional Universitario Carlos Haya, Universidad de Málaga, Málaga, España. 3. Servicio de Reumatología, Hospital Universitario Virgen del Rocío, Sevilla, España. 4. Servicio de Reumatología, Hospital Universitario Virgen de las Nieves, Granada, España. 5. Servicio de Reumatología, Complejo Universitario Hospitalario de A Coruña, A Coruña, España. 6. Servicio de Reumatología, Hospital Universitario de Elche, Elche, Alicante, España. 7. Servicio de Reumatología, Hospital Universitario de Canarias, La Laguna, Tenerife, España. 8. Departamento Médico, Roche, Madrid, España. 9. Servicio de Reumatología, Hospital Universitario La Fe, Valencia, España.
Abstract
OBJECTIVES: To analyze the Spanish experience in an international study which evaluated tocilizumab in patients with rheumatoid arthritis (RA) and an inadequate response to conventional disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor inhibitors (TNFis) in a clinical practice setting. MATERIAL AND METHODS: Subanalysis of 170 patients with RA from Spain who participated in a phase IIIb, open-label, international clinical trial. Patients presented inadequate response to DMARDs or TNFis. They received 8mg/kg of tocilizumab every 4 weeks in combination with a DMARD or as monotherapy during 20 weeks. Safety and efficacy of tocilizumab were analyzed. Special emphasis was placed on differences between failure to a DMARD or to a TNFi and the need to switch to tocilizumab with or without a washout period in patients who had previously received TNFi. RESULTS: The most common adverse events were infections (25%), increased total cholesterol (38%) and transaminases (15%). Five patients discontinued the study due to an adverse event. After six months of tocilizumab treatment, 71/50/30% of patients had ACR 20/50/70 responses, respectively. A higher proportion of TNFi-naive patients presented an ACR20 response: 76% compared to 64% in the TNFi group with previous washout and 66% in the TNFi group without previous washout. CONCLUSIONS: Safety results were consistent with previous results in patients with RA and an inadequate response to DMARDs or TNFis. Tocilizumab is more effective in patients who did not respond to conventional DMARDs than in patients who did not respond to TNFis.
OBJECTIVES: To analyze the Spanish experience in an international study which evaluated tocilizumab in patients with rheumatoid arthritis (RA) and an inadequate response to conventional disease-modifying antirheumatic drugs (DMARDs) or tumornecrosis factor inhibitors (TNFis) in a clinical practice setting. MATERIAL AND METHODS: Subanalysis of 170 patients with RA from Spain who participated in a phase IIIb, open-label, international clinical trial. Patients presented inadequate response to DMARDs or TNFis. They received 8mg/kg of tocilizumab every 4 weeks in combination with a DMARD or as monotherapy during 20 weeks. Safety and efficacy of tocilizumab were analyzed. Special emphasis was placed on differences between failure to a DMARD or to a TNFi and the need to switch to tocilizumab with or without a washout period in patients who had previously received TNFi. RESULTS: The most common adverse events were infections (25%), increased total cholesterol (38%) and transaminases (15%). Five patients discontinued the study due to an adverse event. After six months of tocilizumab treatment, 71/50/30% of patients had ACR 20/50/70 responses, respectively. A higher proportion of TNFi-naive patients presented an ACR20 response: 76% compared to 64% in the TNFi group with previous washout and 66% in the TNFi group without previous washout. CONCLUSIONS: Safety results were consistent with previous results in patients with RA and an inadequate response to DMARDs or TNFis. Tocilizumab is more effective in patients who did not respond to conventional DMARDs than in patients who did not respond to TNFis.