Anifrolumab May Reduce Long-Term Organ Damage in Lupus

TOPLINE

Patients with moderate to severe active systemic lupus erythematosus (SLE) who began treatment with anifrolumab in the TULIP-1 and TULIP-2 trials experienced a statistically significant reduction in organ damage accumulation over 4 years, with a longer duration before the first instance of organ damage progression.

METHODOLOGY:

• Researchers conducted this retrospective study to evaluate the effectiveness of combining anifrolumab with standard-of-care (SOC) treatments in preventing organ damage, compared with SOC only, among adults with moderately to severely active SLE.
• They included 354 patients receiving 300 mg anifrolumab plus SOC from the TULIP trials and 561 real-world external control individuals from University of Toronto Lupus Clinic, Toronto, Ontario, Canada, receiving SOC only; glucocorticoids, antimalarials, nonsteroidal anti-inflammatory drugs, and immunosuppressants were the conventionally used SOCs.
• Analysis included patients aged 18-70 years with a SLE diagnosis ≥ 24 weeks prior, SLE Disease Activity Index 2000 score ≥ 6, and positive antinuclear antibody test.
• Patients in the anifrolumab group were tracked from treatment initiation until death, loss to follow-up, or the week 208 assessment, while those in the real-world SOC group were monitored from their first eligible SOC treatment between January 1995 and December 2023, until death, loss to follow-up, or December 2023.
• The primary endpoint of this study was the change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to week 208, and the secondary endpoint focused on the time until the first increase in the SDI score.

TAKEAWAY:

• From treatment initiation to week 208, the mean change in SDI score was 0.416 points lower in the anifrolumab arm than in the real-world SOC arm (P < .001).
• Patients receiving anifrolumab were 59.9% less likely to experience organ damage progression within 208 weeks (hazard ratio, 0.401; P = .005).
• An estimated 96% (95% CI, 92%-99%) of patients in the anifrolumab group did not experience organ damage progression by week 52, compared with 89% (95% CI, 86%-92%) of patients in the real-world SOC group.
• Post hoc analyses revealed that the largest increases in organ damage occurred in musculoskeletal, ocular, and renal systems.

IN PRACTICE:

“In addition to the proven effectiveness of anifrolumab for controlling disease activity, attaining LLDAS [Lupus Low Disease Activity State] and remission, and enabling glucocorticoid tapering, this study shows that anifrolumab is effective for preventing long-term organ damage compared to RW [real-world] SOC. The results of our study therefore support the benefit of adding anifrolumab to SOC for minimizing long-term organ damage in patients with SLE,” the authors wrote.

SOURCE:

The study was led by Zahi Touma, MD, University of Toronto Lupus Clinic, Centre for Prognosis Studies in Rheumatic Diseases, Toronto Western Hospital, Toronto. It was published online on February 7, 2025, in Annals of the Rheumatic Diseases.

LIMITATIONS:

Differential outcome misclassification could have affected the results due to a combination of trial and real-world data sources. Changes in SOC over time, particularly the introduction of mycophenolate mofetil in the early 2000s and biologic agents since 2020, may have affected study results. This study excluded real-world patients who had received any biologic agents within 4 weeks before receiving one or more eligible SOC treatments; however, the authors acknowledge that these patients could have received such treatments during the follow-up period.

DISCLOSURES:

This study was funded by AstraZeneca. Some authors declared receiving grants, consulting fees, speaker fees, payments, honoraria, and support for attending meetings and having other ties with many sources, including AstraZeneca.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.