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Effectiveness of Belimumab After Rituximab in Systemic Lupus Erythematosus : A Randomized Controlled Trial
Muhammad Shipa1, Andrew Embleton-Thirsk1, Mariea Parvaz1
1University College London, London, United Kingdom (M.S., A.E., M.P., L.R.S., P.M., K.C., D.A.I., C.J.D., M.R.E.).
Annals of Internal Medicine
|October 26, 2021
Summary
Adding belimumab after rituximab therapy significantly reduced anti-double-stranded DNA antibody levels and severe flares in patients with refractory systemic lupus erythematosus (SLE). This combination shows promise as a therapeutic strategy for SLE management.
Area of Science:
- Immunology
- Rheumatology
- Pharmacology
Background:
- Systemic lupus erythematosus (SLE) treatment with rituximab shows variable responses.
- High B-cell activating factor (BAFF) levels post-rituximab may contribute to SLE flares.
- Investigating belimumab's efficacy following rituximab for refractory SLE.
Purpose of the Study:
- To evaluate the efficacy of belimumab in patients with SLE refractory to conventional therapy, after rituximab treatment.
- To assess the impact of belimumab on key serological markers and disease flares in SLE patients.
Main Methods:
- A Phase 2, randomized, double-blind, placebo-controlled trial involving 52 SLE patients.
- Patients received rituximab, followed by randomization to belimumab or placebo for 52 weeks.
- Primary endpoint: serum IgG anti-dsDNA antibody levels at 52 weeks; secondary: disease flares and adverse events.
Main Results:
- Belimumab significantly reduced IgG anti-dsDNA antibody levels compared to placebo (70% greater reduction).
- Belimumab decreased the risk of severe SLE flares (hazard ratio 0.27, P=0.033).
- Belimumab did not increase serious adverse events and suppressed B-cell repopulation.
Conclusions:
- Belimumab administered after rituximab is effective in reducing anti-dsDNA antibodies and severe flares in refractory SLE.
- The combination therapy of belimumab and rituximab presents a potential therapeutic strategy for SLE.
- Further development of this combination therapy is warranted for managing refractory SLE.
