Low-dose interleukin-2 for the treatment of systemic lupus erythematosus: A systematic review and meta-analysis.
Roberto Colli, Lara Bader, Evgenios Kladis et al.
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In 30 seconds
This systematic review and meta-analysis assessed clinical efficacy and safety of low-dose interleukin-2 (IL-2) in patients with systemic lupus erythematosus (SLE). Nine trials were included: six open-label studies and three randomised controlled trials, involving 584 patients treated with IL-2 and 140 receiving conventional treatment or placebo. Across studies, IL-2 treatment was associated with a reduction in SLE Disease Activity Index (SLEDAI) scores (mean difference -4.62 [95% CI -5.83, -3.40]; I² = 94.4%). Disease markers and regulatory T-cell counts also improved, while controlled studies showed less conclusive but directionally favourable results.
Key findings
- SLEDAI scores decreased with low-dose IL-2 treatment: mean difference -4.62 [95% CI -5.83, -3.40]; I² = 94.4%.
- Treatment was associated with lower anti-dsDNA antibody titers and higher complement C3 and C4 levels and Treg cell counts.
- Controlled studies only partially reached statistical significance but consistently favoured IL-2 for response rates and prednisone reductions.
- Few adverse events were reported, and most were minor.
Why it matters
The findings suggest low-dose IL-2 may reduce measured SLE activity and affect immunological markers, with few reported adverse events. However, the high heterogeneity and less definitive results in controlled studies mean the pooled estimate should not be taken as a settled measure of benefit. Larger controlled trials are needed to establish the size and clinical importance of any effect.
What to keep in mind
The evidence includes open-label studies, and the pooled SLEDAI result had substantial heterogeneity (I² = 94.4%). Controlled studies only partially achieved statistical significance.