Efficacy of rituximab versus cyclophosphamide in lupus patients with severe manifestations. A randomized and multicenter study

Andrade-Ortega, Lilia; Irazoque-Palazuelos, Fedra; López-Villanueva, Ricardo F.; Barragán-Navarro, Yaneth; Bourget-Pietrasanta, Fernando; Díaz-Ceballos, Maria de los Ángeles; Hernández-Paz, Roberto; Urenda-Quezada, Adelfia; Rivas-Ruíz, Rodolfo

doi:10.1016/s2173-5743(10)70058-7

Cited by 10 publications

(16 citation statements)

References 28 publications

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“…10,11 There has been much debate about the reasons for this lack of evidence and concerns about the design of these trials as clinical experience of many experts in the field and results of large open-label studies favour the use of rituximab in this disease. [12][13][14][15][16] Although further clinical trials may be launched to further investigate the efficacy of rituximab in SLE, it is unlikely that approval of rituximab for SLE will be gained in the near future. Given the urgent need for effective, safe and tolerable treatment options for SLE patients, in particular in disease refractory to standard measures of care, it is of great importance that experiences with the off-label use of rituximab are collected and made accessible to physicians treating these patients.…”

Section: Introductionmentioning

confidence: 99%

Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE) – results from a nationwide cohort in Germany (GRAID)

Witt

Grünke

Proft

et al. 2013

Lupus

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Objective: The objective of this article is to evaluate the safety and clinical outcome of rituximab treatment in systemic lupus erythematosus (SLE) patients refractory to standard of care therapy in a real-life setting in Germany. Methods: The GRAID registry included patients with different autoimmune diseases who were given off-label treatment with rituximab. Data on safety and clinical response were collected retrospectively. In SLE patients, clinical parameters included tender and swollen joint counts, fatigue, myalgia, general wellbeing, Raynaud's and the SLEDAI index. Laboratory tests included dsDNA antibody titres, complement factors, hematologic parameters and proteinuria. Finally, the investigators rated their patients as non-, partial or complete responders based on clinical grounds. Results: Data from 85 SLE patients were collected, 69 female and 16 male, with a mean disease duration of 9.8 years. The mean follow-up period was 9.6 AE 7.4 months, resulting in 66.8 patient years of observation. A complete response was reported in 37 patients (46.8%), partial response in 27 (34.2%), no response in 15 (19.0%). On average, major clinical as well as laboratory efficacy parameters improved substantially, with the SLEDAI decreasing significantly from 12.2 to 3.3 points. Concerning safety, one infusion reaction leading to discontinuation of treatment occurred. Infections were reported with a rate of 19.5 (including six severe infections) per 100 patient years. Conclusion: With the restrictions of a retrospective data collection, the results of this study confirm data of other registries, which suggest a favourable benefit-risk ratio of rituximab in patients with treatment-refractory SLE. Lupus (2013) 22, 1142-1149.

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Section: Introductionmentioning

confidence: 99%

Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE) – results from a nationwide cohort in Germany (GRAID)

Witt

Grünke

Proft

et al. 2013

Lupus

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“…The results favored rituximab and although all patients had severe manifestations of the disease as a criterion for inclusion, a significant percentage had joint manifestations, which improved. 22 The results of the French registry of lupus patients treated with rituximab have been recently published. The authors found an adequate clinical response in about 80% of patients, specifically, improvement occurred for articular manifestations in 72%.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Tolerability of Rituximab in Patients With Rhupus

Andrade-Ortega

Irazoque-Palazuelos

Muñoz-López

et al. 2013

Reumatología Clínica (English Edition)

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“…The remaining 38 articles were assessed independently after a full-text reading by two reviewers (SSW and JJZ). At the end of the screening, 2 RCTs and 13 observational studies were included based on the established inclusion criteria 9,10,[12][13][14][15][16][17][18][19][20][21][22][23][24] . A flowchart of the literature search and screening procedure is shown in Fig.…”

Section: Review Profiles and Included Studiesmentioning

confidence: 99%

“…Evaluation of the efficacy of rituximab in observational studies Observational studies data were grouped in this meta-analysis. Thirteen observational studies involving 341 patients (254 females) were included [12][13][14][15][16][17][18][19][20][21][22][23][24] . Summarized baseline characteristics of the included studies are shownin Table 3.…”

Section: Safety Of Rituximab In Rctsmentioning

confidence: 99%

“…In a total of 6 studies 14,17,[21][22][23][24] , 153 patients showed a net change in the SLE Disease Activity Index (SLE-DAI) score. We adopted the random-effects model and observed that relative to baseline, rituximab useresulted in a significantly decreased in the "after rituximab" group (WMDrandom=-12.31, 95% CI=-14.09--10.52, I 2 =57%, P<0.00001, Fig.…”

Section: Safety Of Rituximab In Rctsmentioning

confidence: 99%

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Efficacy and safety of rituximab for systemic lupus erythematosus treatment: a meta-analysis

Wu¹,

Wang²,

Zhang³

et al. 2020

Afr H. Sci.

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Background: Given the inconsistency of previous studies and the newly emerging evidence, we decided to conduct a me- ta-analysis. Methods: The meta-analysis included 2 randomized controlled trials and 13 observational studies 742 patients in total. Qualified studies were properly searched from databases . Data were analyzed by the RevMan 5.3 software. Results were demonstrated as WMD , SMD and RR with 95% CIs, I2 and P value. Results: We observed that a remarkable increase of complement C3 in the rituximab group than placebo group (WMD- fixed=7.67mg/dL, 95%CIs=-0.16~15.50, I2=0%, P=0.05). A significant increase of complement C4 was observed in the rituximab group than placebo group (WMDfixed=3.14mg/dL, 95%CIs=1.06~5.22, I2=0%, P=0.003). Notably decreased peripheral CD19+B cells in rituximab group than placebo group (WMDfixed=-117.93n/μl, 95%CIs=-172.94~-62.91, I2=0%, P<0.0001) in RCTs. Patients with severe or refractory SLE got more satisfactory efficacy results after receiving rituximab in observational studies, such as British Isles Lupus Assessment Group index score, SLE Disease Activity Index score, complement C3/C4, anti-dsDNA antibodies, peripheral CD19+B cells and so on. Safety profiles were no difference between rituximab and placebo groups. Conclusion: although the efficacy of rituximab is highly controversial for SLE, our study shows that rituximab presents a satisfying efficacy and safety for SLE. Keywords: Efficacy; safety; rituximab; systemic lupus erythematosus; meta-analysis.

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Efficacy of rituximab versus cyclophosphamide in lupus patients with severe manifestations. A randomized and multicenter study

Cited by 10 publications

References 28 publications

Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE) – results from a nationwide cohort in Germany (GRAID)

Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE) – results from a nationwide cohort in Germany (GRAID)

Efficacy and Tolerability of Rituximab in Patients With Rhupus

Efficacy and safety of rituximab for systemic lupus erythematosus treatment: a meta-analysis

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