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Rituximab use in pediatric systemic lupus erythematosus: Indications, efficacy and safety in an Indian cohort
Sujata Sawhney1, Manjari Agarwal1
1Division of Pediatric Rheumatology, 28928Sir Ganga Ram Hospital, Institute of Child Health, Sir Ganga Ram Hospital, New Delhi, India.
Insights
Rituximab (RTX) effectively treats pediatric lupus, significantly reducing disease activity and steroid dependence. This study shows RTX is safe and beneficial for children with lupus, even in regions with high infectious disease burdens.
Area of Science:
- Pediatric Rheumatology
- Immunology
- Clinical Medicine
Background:
- Childhood-onset systemic lupus erythematosus (SLE) presents unique challenges compared to adult SLE.
- Achieving sustained remission with minimal steroid use is the primary therapeutic goal in pediatric lupus.
- Rituximab (RTX) is an off-label option for managing refractory pediatric SLE cases.
Purpose of the Study:
- To evaluate the utilization, effectiveness, and safety of Rituximab (RTX) in a cohort of pediatric lupus patients.
- To assess RTX's impact on disease activity, steroid requirements, and proteinuria in childhood SLE.
- To contribute data on RTX use in pediatric lupus from a developing country context.
Main Methods:
- Retrospective review of pediatric lupus patients treated with RTX over 17 years at a North Indian tertiary center.
- Analysis of indications for RTX use, including resistant renal disease.
- Assessment of clinical outcomes, including SLEDAI scores, steroid dosage, proteinuria, and flare rates post-RTX initiation.
Main Results:
- RTX was administered to 7.5% of pediatric lupus patients, primarily for resistant renal disease (53%).
- Significant reduction in mean SLEDAI from 16.25 to 1.43 (p=0.001) and steroid use from 100% to 33% at 2 years.
- Sustained proteinuria reduction (mean urine spot protein creatinine ratio from 3.1 to 0.4, p=0.006) and 82% of patients remained flare-free during follow-up (median 24 months).
- No adverse events were reported during RTX treatment.
Conclusions:
- Rituximab (RTX) demonstrates high efficacy and a favorable safety profile in treating pediatric systemic lupus erythematosus.
- RTX offers a valuable therapeutic option for achieving sustained remission and reducing steroid dependency in children with lupus.
- This study supports the use of RTX in pediatric lupus, even in resource-limited settings with high infectious disease prevalence.
Abstract:
Introduction: Children with systemic lupus erythematosus have a more challenging and difficult course as compared to their adult counterparts. Today, the aim of therapy for any child with lupus is to keep the child in a state of sustained remission with minimal or no use of steroids. This laudable goal is often difficult to achieve for the child with lupus. In addition to the use of disease modifying agents, sometimes in combination, Rituximab (RTX) is also used as an off-label indication to manage such patients.Objectives: To study the use, efficacy and safety of RTX in a cohort of patients with pediatric lupus followed at a single tertiary level center in Northern India.Methods: This paper is a retrospective review looking at the use of RTX in children with systemic lupus at a tertiary level pediatric rheumatology center in North India over a period of seventeen years. This paper describes the indications, use, efficacy and safety of RTX in childhood systemic lupus erythematosus.Results: RTX was used in 17 of 225 pediatric lupus patients (7.5%), with the most common indication being resistant renal disease (53%). Significant improvement was seen in all domains studied: The mean SLEDAI was 16.25 prior to RTX and reduced to 1.43 six months after the RTX (p value 0.001), steroid use dropped from 100% pre- RTX to 33% at 2 years, there was a sustained reduction in proteinuria in the patients with nephritis from a mean urine spot protein creatinine ratio of 3.1 pre RTX to 0.4 at one year post RTX (p= .006). Finally, 82% of the children had no flare during the follow up (median 24 months). No patient had any adverse event.Conclusions: This study confirms that RTX is very effective in childhood lupus and can be safely used even in a country with a very high burden of infectious diseases. This data adds to the scarce literature in this area from the developing world.
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