Anifrolumab Delayed Onset of Organ Damage in Patients With SLE

Patients with moderate-to-severe systemic lupus erythematosus (SLE) that were treated with long-term anifrolumab had lower rates of damage accrual and a delayed onset of irreversible organ damage.¹

These data, from the phase 3 LASER study (NCT06485674), were presented by Zahi Touma, MD, PhD, director, Toronto Lupus Program and Associate Professor of medicine, department of medicine, division of rheumatology, Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, at the American College of Rheumatology (ACR) Convergence 2024, held November 14-19 in Washington, DC.

The LASER study included 354 patients assigned to anifrolumab300 mg in the TULIP-1/-2 trials in the anifrolumab arm and an external control (standard of care) arm including 561 biologic-naïve patients from the University of Toronto Lupus Clinic (UTLC) cohort who matched key eligibility criteria from TULIP.¹

Touma and colleagues found that patients receiving SOC had a greater increase in SLICC/ACR Damage Index (SDI) than those treated with anifrolumab after 4 years. Propensity score matching (PSM) found that the anifrolumab arm had a mean 0.201 (95% CI, 0.119–0.283) and the SOC arm had a mean 0.571 (95% CI, 0.380–0.761) change in SDI (mean difference –0.370; P = .002). Overall, patients in the anifrolumab arm had a 59.9% lower risk of first SDI progression over 48 months compared with SOC (hazard ratio, 0.401 [95% CI, 0.213–0.753]; P<.01).¹

Another recent update in Lupus care at the ACR meeting was the release of a summary of the 2024 ACR Guideline for the Screening, Treatment, and Management of Lupus Nephritis.²

"At the time the ACR released its last lupus nephritis clinical practice guidelines, recommendations called for induction therapy with high-dose glucocorticoids plus immunosuppressant medications like mycophenolate mofetil or cyclophosphamide and endorsed mycophenolate for maintenance therapy,” Lisa Sammaritano, MD, lead author on the guideline, professor of clinical medicine at Weill Cornell Medicine, and an attending physician in the Hospital for Special Surgery Division of Rheumatology, said in a statement.² “Since then, belimumab and voclosporin have been approved by the US Food and Drug Administration for treatment, prompting a conceptual shift from induction and maintenance therapy to one of combination, ongoing therapy targeting different parts of the immune system.”

The guideline summary provides 41 recommendations and good practice statements. The strong recommendations include arecommendation to screen at least every 6-12 months for proteinuria in patients with SLE without known kidney disease and a recommendation to quantify proteinuria at least every 3 months in patients with lupus nephritis who have not achieved complete renal response and every 3-6 months in patients with sustained complete renal response.²

“We also acknowledge that therapeutic decisions will vary depending on clinical presentation and patient preferences and may be limited by access to specialists, procedures, and medications,” Dr. Sammaritano added.² “When recommended medications are unavailable, this guideline should not preclude using available traditional therapies.”

REFERENCES

1. Touma Z, Bruce I, Furie RA, et al. Anifrolumab Long-Term Treatment Is More Effective Against Organ Damage Than Standard of Care Alone: Results from an External Control Arm Study on Organ Damage in Phase 3 Clinical Trials and the University of Toronto Lupus Clinic Cohort. Presented at: ACR Convergence 2024; November 14-19; Washington, DC. Abstract L13

2. New ACR guideline summary provides guidance to screen, treat, and manage lupus nephritis. News release. ACR. November 18, 2024. https://rheumatology.org/press-releases/new-acr-guideline-summary-provides-guidance-to-screen-treat-and-manage-lupus-nephritis