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Long-term treatment with anifrolumab may delay the onset of irreversible organ damage and reduce the damage accrual rate in patients with moderate to severe systemic lupus erythematosus (SLE), results from an external control arm study suggest.
In SLE, persistent disease activity, flares, and long-term glucocorticoid use all contribute to organ damage accrual. It is difficult to evaluate the effects of novel therapies on organ damage in clinical trials due to attrition of patients receiving standard-of-care (SOC) and limited study duration. To assess the effects of anifrolumab versus SOC on long-term organ damage in patients with active SLE, the LASER study (NCT06485674) was set up as an external control arm study. The results were presented by Dr. Zahi Touma, MD, PhD, from the University of Toronto, in Canada1.
Patients were randomly assigned to anifrolumab 300 mg in the TULIP-1 (NCT02446912) and TULIP-2 trials (NCT02446899) and the subsequent long-term extension (LTE) trial (NCT02794285) were included in the anifrolumab arm (n=354). The external control arm receiving SOC (n=561) included biological-naïve patients from the University of Toronto Lupus Clinic (UTLC) cohort who matched key eligibility criteria from TULIP. The primary endpoint was the mean difference in organ damage, as measured with the SLICC–ACR Damage Index (SDI), after 48 months, adjusting for SDI at baseline.
Most covariates were balanced between the TULIP and UTLC cohorts. Patients in the anifrolumab arm had a 59.9% lower risk for the first SDI progression (increase) over 48 months from the index date (HR 0.40; 95% CI 0.21–0.75; P<0.01). All mean changes in SDI over 48 months were significantly lower with anifrolumab versus SOC in:
- The average treatment effect in controls was estimated: at -0.416 (95% CI -0.582 to -0.249; P<0.0001).
- The average treatment effect on treated patients was estimated: -0.337 (95% CI -0.524 to -0.150; P<0.0001).
- The average treatment effect in the overlap analysis (n=116 in both groups): -0.370 (95% CI 0.578 to -0.163; P<0.0001).
The authors concluded that the known benefits of anifrolumab in controlling disease activity and reducing glucocorticoid use probably contribute to organ damage prevention.
Medical writing support was provided by Michiel Tent
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