Safety and clinical outcomes of rituximab therapy in patients with different autoimmune diseases: experience from a national registry (GRAID)
Open Access
- 1 January 2011
- journal article
- research article
- Published by Springer Science and Business Media LLC in Arthritis Research & Therapy
- Vol. 13 (3), R75-14
- https://doi.org/10.1186/ar3337
Abstract
Evidence from a number of open-label, uncontrolled studies has suggested that rituximab may benefit patients with autoimmune diseases who are refractory to standard-of-care. The objective of this study was to evaluate the safety and clinical outcomes of rituximab in several standard-of-care-refractory autoimmune diseases (within rheumatology, nephrology, dermatology and neurology) other than rheumatoid arthritis or non-Hodgkin's lymphoma in a real-life clinical setting. Patients who received rituximab having shown an inadequate response to standard-of-care had their safety and clinical outcomes data retrospectively analysed as part of the German Registry of Autoimmune Diseases. The main outcome measures were safety and clinical response, as judged at the discretion of the investigators. A total of 370 patients (299 patient-years) with various autoimmune diseases (23.0% with systemic lupus erythematosus, 15.7% antineutrophil cytoplasmic antibody-associated granulomatous vasculitides, 15.1% multiple sclerosis and 10.0% pemphigus) from 42 centres received a mean dose of 2,440 mg of rituximab over a median (range) of 194 (180 to 1,407) days. The overall rate of serious infections was 5.3 per 100 patient-years during rituximab therapy. Opportunistic infections were infrequent across the whole study population, and mostly occurred in patients with systemic lupus erythematosus. There were 11 deaths (3.0% of patients) after rituximab treatment (mean 11.6 months after first infusion, range 0.8 to 31.3 months), with most of the deaths caused by infections. Overall (n = 293), 13.3% of patients showed no response, 45.1% showed a partial response and 41.6% showed a complete response. Responses were also reflected by reduced use of glucocorticoids and various immunosuppressives during rituximab therapy and follow-up compared with before rituximab. Rituximab generally had a positive effect on patient well-being (physician's visual analogue scale; mean improvement from baseline of 12.1 mm). Data from this registry indicate that rituximab is a commonly employed, well-tolerated therapy with potential beneficial effects in standard of care-refractory autoimmune diseases, and support the results from other open-label, uncontrolled studies.Keywords
This publication has 71 references indexed in Scilit:
- Rituximab versus Cyclophosphamide in ANCA-Associated Renal VasculitisNew England Journal of Medicine, 2010
- B cells as therapeutic targets in SLENature Reviews Rheumatology, 2010
- The red wolf remains a wily foeNature Reviews Rheumatology, 2010
- Rituximab for Peripheral Ulcerative Keratitis With Wegener GranulomatosisCornea, 2010
- Immunosuppressive disorders and risk of anal squamous cell carcinoma: A nationwide cohort study in Denmark, 1978–2005International Journal of Cancer, 2010
- Different response to rituximab in tumor necrosis factor blocker–naive patients with active ankylosing spondylitis and in patients in whom tumor necrosis factor blockers have failed: A twenty‐four–week clinical trialArthritis & Rheumatism, 2010
- Efficacy and Safety of Retreatment in Patients with Rheumatoid Arthritis with Previous Inadequate Response to Tumor Necrosis Factor Inhibitors: Results from the SUNRISE TrialThe Journal of Rheumatology, 2010
- The relationship of FcγRIIIa genotype to degree of B cell depletion by rituximab in the treatment of systemic lupus erythematosusArthritis & Rheumatism, 2003
- An open study of B lymphocyte depletion in systemic lupus erythematosusArthritis & Rheumatism, 2002
- Response of Wegener's granulomatosis to anti-CD20 chimeric monoclonal antibody therapyArthritis & Rheumatism, 2001