Tatiana Cobo-Ibáñez1, Estíbaliz Loza-Santamaría2, José María Pego-Reigosa3, Alejandro Olivé Marqués4, Iñigo Rúa-Figueroa5, Antonio Fernández-Nebro6, Rafael Cáliz Cáliz7, Francisco Javier López Longo8, Santiago Muñoz-Fernández9. 1. Rheumatology Department, Hospital Universitario Infanta Sofía, Paseo de Europa, 34, San Sebastián de los Reyes 28702, Madrid, Spain. Electronic address: mtcoboiba@yahoo.es. 2. Institute for Musculoskeletal Health, Madrid, Spain. 3. Rheumatology Department, Vigo, Department, Instituto de Investigación Biomédica de Vigo (IBIV), Vigo, Spain. 4. Rheumatology Department, Hospital Universitario Germans Trías i Pujol, Badalona, Barcelona, Spain. 5. Rheumatology Department, Hospital Universitario Doctor Negrín, Las Palmas de Gran Canaria, Spain. 6. Rheumatology Department, Hospital Regional Universitario de Málaga, Universidad de Málaga, Instituto de Investigación biomédica de Málaga (IBIMA), Málaga, Spain. 7. Rheumatology Department, Hospital General Universitario Virgen de las Nieves, Granada, Spain. 8. Rheumatology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain. 9. Rheumatology Department, Hospital Universitario Infanta Sofía, Paseo de Europa, 34, San Sebastián de los Reyes 28702, Madrid, Spain.
Abstract
OBJECTIVE: To analyse the efficacy and safety of rituximab in the treatment of non-renal systemic lupus erythematosus (SLE). METHODS: We systematically searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials up to June 2013. The following were the selection criteria: (1) adult patients with SLE, (2) rituximab treatment, (3) placebo or active comparator, (4) outcome measures assessing efficacy and/or (5) safety. Meta-analysis, systematic literature reviews, randomised control trials (RCT), open clinical trials and cohort studies were included. Independent extraction of articles by 2 authors using predefined data fields was performed. The quality of each study was graded using the Oxford Levels of Evidence and Jadad's scale. RESULTS: A total of 26 articles met our inclusion criteria: one RCT and its exploratory analysis, 2 open studies and 22 cohort studies, which analysed 1,231 patients. Overall, patients had active disease refractory to steroids and/or immunosuppressant drugs. Acceptable evidence suggested improvements in disease activity, arthritis, thrombocytopaenia, complement and anti-dsDNA, with a steroid-sparing effect. But relapses of disease were demonstrated too. Weak evidence suggested a response in anaemia, cutaneous and neuropsychiatric manifestations. Available evidence revealed few major adverse events. Studies had medium methodological quality and in general were applicable to current practice. CONCLUSION: Rituximab has been shown to be safe and effective in the treatment of non-renal SLE, especially in terms of disease activity, immunologic parameters and steroid-sparing effect. However, it can only be recommended for organ-specific manifestations such as arthritis and thrombocytopaenia. High-quality studies are needed in order to consider the long-term effects of re-treatment on different organ-specific manifestations.
OBJECTIVE: To analyse the efficacy and safety of rituximab in the treatment of non-renal systemic lupus erythematosus (SLE). METHODS: We systematically searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials up to June 2013. The following were the selection criteria: (1) adult patients with SLE, (2) rituximab treatment, (3) placebo or active comparator, (4) outcome measures assessing efficacy and/or (5) safety. Meta-analysis, systematic literature reviews, randomised control trials (RCT), open clinical trials and cohort studies were included. Independent extraction of articles by 2 authors using predefined data fields was performed. The quality of each study was graded using the Oxford Levels of Evidence and Jadad's scale. RESULTS: A total of 26 articles met our inclusion criteria: one RCT and its exploratory analysis, 2 open studies and 22 cohort studies, which analysed 1,231 patients. Overall, patients had active disease refractory to steroids and/or immunosuppressant drugs. Acceptable evidence suggested improvements in disease activity, arthritis, thrombocytopaenia, complement and anti-dsDNA, with a steroid-sparing effect. But relapses of disease were demonstrated too. Weak evidence suggested a response in anaemia, cutaneous and neuropsychiatric manifestations. Available evidence revealed few major adverse events. Studies had medium methodological quality and in general were applicable to current practice. CONCLUSION:Rituximab has been shown to be safe and effective in the treatment of non-renal SLE, especially in terms of disease activity, immunologic parameters and steroid-sparing effect. However, it can only be recommended for organ-specific manifestations such as arthritis and thrombocytopaenia. High-quality studies are needed in order to consider the long-term effects of re-treatment on different organ-specific manifestations.