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Semin Arthritis Rheum. 2014 Oct;44(2):175-85. doi: 10.1016/j.semarthrit.2014.04.002. Epub 2014 Apr 13.

Efficacy and safety of rituximab in the treatment of non-renal systemic lupus erythematosus: a systematic review.

Author information

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.

KEYWORDS:

Rituximab; Systematic review; Systemic lupus erythematosus

[Indexed for MEDLINE]

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