The indications, efficacy and adverse events of rituximab in a large cohort of patients with juvenile-onset SLE

Lupus. 2015 Jan;24(1):10-7. doi: 10.1177/0961203314547793. Epub 2014 Aug 12.

Abstract

Background: B cells drive antibody formation and T cell activation. This study aimed to describe the clinical indications, efficacy and adverse events (AEs) for the B-cell depleting agent, rituximab, in a large cohort of children with lupus.

Methods: Prescribing records and the UK JSLE Cohort Study database identified rituximab use.

Results: Sixty-three patients received 104 courses of intravenous rituximab over a 10-year period. Patients were aged 12.2 (IQR 9.0-13.9) years at diagnosis and 50 (79%) were female. They had disease for 1.4 (0.2-3.0) years at the time of rituximab. Lupus nephritis was the most common indication (36% of first courses). Clinical biomarkers, 2.5 (1.6-4.3) months after treatment, demonstrated a statistically significant improvement in ESR, C3, C4, creatinine, albumin, haemoglobin, anti-dsDNA titres and urine albumin:creatinine ratio. IgG, IgA and IgM levels decreased (p < 0.01). Oral corticosteroid dose significantly reduced after rituximab (dose before 0.26 (0.09-0.44) mg/kg, after 0.17 (0.09-0.30) mg/kg; p = 0.01)). AEs occurred in 19 (18%) of all courses including; delayed second dose (8%), Ig replacement (2%) and infusion reactions (6%; anaphylaxis 2%). The global BILAG score showed a trend toward improvement (before 4.5 (2.0-9.0), after 3.0 (2.0-5.0); p = 0.16).

Conclusion: Rituximab improves disease activity in children with lupus and serious AEs are infrequent. Controlled studies are required.

Keywords: B-cell depletion; Rituximab; SLE; child; lupus.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adrenal Cortex Hormones / therapeutic use
  • Albuminuria / urine
  • Antibodies, Antinuclear / blood
  • Antibodies, Monoclonal, Murine-Derived / adverse effects
  • Antibodies, Monoclonal, Murine-Derived / therapeutic use*
  • B-Lymphocytes*
  • Biomarkers / blood
  • Biomarkers / urine
  • Blood Sedimentation
  • Child
  • Complement C3 / metabolism
  • Complement C4 / metabolism
  • Creatinine / blood
  • Creatinine / urine
  • DNA / immunology
  • Female
  • Hemoglobins / metabolism
  • Humans
  • Immunoglobulins / blood
  • Immunologic Factors / adverse effects
  • Immunologic Factors / therapeutic use*
  • Lupus Erythematosus, Systemic / blood
  • Lupus Erythematosus, Systemic / drug therapy*
  • Lymphocyte Count
  • Male
  • Retrospective Studies
  • Rituximab
  • Serum Albumin / metabolism

Substances

  • Adrenal Cortex Hormones
  • Antibodies, Antinuclear
  • Antibodies, Monoclonal, Murine-Derived
  • Biomarkers
  • Complement C3
  • Complement C4
  • Hemoglobins
  • Immunoglobulins
  • Immunologic Factors
  • Serum Albumin
  • Rituximab
  • DNA
  • Creatinine