OBJECTIVE: Rituximab seems well tolerated in patients with rheumatoid arthritis (RA). However, variations in the gammaglobulin profile that might increase the infection risk have been reported. Here, our objective was to evaluate gammaglobulin concentrations and the infection risk in patients receiving rituximab therapy for RA in everyday practice. METHODS: Prospective single-center observational study of 65 patients with refractory RA (median age, 59 years; range, 26-83) treated with rituximab 1 g twice 15 days apart, with or without a further 1-g dose at least 6 months later depending on the clinical response. Gammaglobulins were assayed before each rituximab dose. RESULTS: The median cumulative rituximab dose was 4 g (1-16) and the median time to retreatment was 8 months (6-16). Rituximab therapy significantly improved the DAS-28 score. The gammaglobulin concentration decreased significantly between the first and last rituximab dose (from 11.6 g/L [5-26] to 8.2 g/L [3-20], a -2.6 g/L difference; P<0.05). The decrease was larger in the 24 patients with cumulative rituximab doses greater than 5 g than in the 41 other patients (difference of -4 vs. -2.7 g/L; P<0.05). Three patients experienced severe infections, two in the high-dose group and one in the other group (P=0.5). CONCLUSION: These data obtained in everyday practice constitute further evidence that rituximab is well-tolerated in patients with RA. Rituximab therapy was associated with a decrease in gammaglobulin concentrations that was greater in patients receiving higher cumulative doses.
OBJECTIVE:Rituximab seems well tolerated in patients with rheumatoid arthritis (RA). However, variations in the gammaglobulin profile that might increase the infection risk have been reported. Here, our objective was to evaluate gammaglobulin concentrations and the infection risk in patients receiving rituximab therapy for RA in everyday practice. METHODS: Prospective single-center observational study of 65 patients with refractory RA (median age, 59 years; range, 26-83) treated with rituximab 1 g twice 15 days apart, with or without a further 1-g dose at least 6 months later depending on the clinical response. Gammaglobulins were assayed before each rituximab dose. RESULTS: The median cumulative rituximab dose was 4 g (1-16) and the median time to retreatment was 8 months (6-16). Rituximab therapy significantly improved the DAS-28 score. The gammaglobulin concentration decreased significantly between the first and last rituximab dose (from 11.6 g/L [5-26] to 8.2 g/L [3-20], a -2.6 g/L difference; P<0.05). The decrease was larger in the 24 patients with cumulative rituximab doses greater than 5 g than in the 41 other patients (difference of -4 vs. -2.7 g/L; P<0.05). Three patients experienced severe infections, two in the high-dose group and one in the other group (P=0.5). CONCLUSION: These data obtained in everyday practice constitute further evidence that rituximab is well-tolerated in patients with RA. Rituximab therapy was associated with a decrease in gammaglobulin concentrations that was greater in patients receiving higher cumulative doses.
Authors: Isidoro González-Álvaro; Carmen Martínez-Fernández; Benito Dorantes-Calderón; Rosario García-Vicuña; Blanca Hernández-Cruz; Alicia Herrero-Ambrosio; Olatz Ibarra-Barrueta; Emilio Martín-Mola; Emilio Monte-Boquet; Alberto Morell-Baladrón; Raimon Sanmartí; Jesús Sanz-Sanz; Francisco Javier de Toro-Santos; Paloma Vela; José Andrés Román Ivorra; José Luis Poveda-Andrés; Santiago Muñoz-Fernández Journal: Rheumatology (Oxford) Date: 2014-12-19 Impact factor: 7.580
Authors: Jean G Sathish; Swaminathan Sethu; Marie-Christine Bielsky; Lolke de Haan; Neil S French; Karthik Govindappa; James Green; Christopher E M Griffiths; Stephen Holgate; David Jones; Ian Kimber; Jonathan Moggs; Dean J Naisbitt; Munir Pirmohamed; Gabriele Reichmann; Jennifer Sims; Meena Subramanyam; Marque D Todd; Jan Willem Van Der Laan; Richard J Weaver; B Kevin Park Journal: Nat Rev Drug Discov Date: 2013-04 Impact factor: 112.288