7 days ago
Long-Term Anifrolumab Use Improves Quality of Life in Lupus
Patients with moderate to severe active systemic lupus erythematosus (SLE) who continued anifrolumab treatment over 4 years showed sustained improvements in health status and quality of life, along with improvements in health utilities and employment measures.
METHODOLOGY:
Researchers conducted an extension trial (TULIP-LTE) to assess the long-term effects of anifrolumab treatment on patient-reported outcomes in SLE at baseline through week 208.
They included 369 patients with moderate to severe SLE who were randomly assigned to receive either 300 mg anifrolumab (n = 257; mean age, 43.4 years; 92% women) or placebo (n = 112; mean age, 41.4 years; 92% women) every 4 weeks.
These patients had completed the 1-year TULIP-1 and TULIP-2 trials and maintained the same treatment in the long-term extension study.
Exploratory endpoints were changes in patient-reported outcomes related to health status and health-related quality of life.
TAKEAWAY:
At week 208, the anifrolumab group had numerically higher Short Form-36 version 2 acute recall scores for mental health and bodily pain domains than the placebo group (least squares mean [LSM] difference, 3.7; 95% CI, −1.2 to 8.6 and 5.9; 95% CI, −0.7 to 12.5, respectively).
The Short Form-6 Dimension scores showed numerically greater improvements in the anifrolumab group than in the placebo group, with differences evident from week 24 (LSM difference, 0.013; 95% CI, −0.007 to 0.032) and sustained through week 208 (LSM difference, 0.016; 95% CI, −0.010 to 0.042).
Similarly, Patient Global Assessment and EuroQoL 5 Dimensions–derived Single Summary Utility Index scores showed numerically greater improvements in the anifrolumab group than in the placebo group at week 208.
At week 208, the proportion of patients in paid employment remained stable in both the anifrolumab and placebo groups (45% vs 44%), with both groups showing similar reductions in the number of work hours missed in the preceding week.
IN PRACTICE:
'These findings highlight the importance of including patient-reported outcomes as single, composite indices (eg, SF-6D) in clinical trials to allow comprehensive assessment of meaningful benefit for patients,' the authors wrote.
SOURCE:
This study was led by Vibeke Strand, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, and was published online on May 2, 2025, in The Lancet Rheumatology .
LIMITATIONS:
The exploratory and post hoc nature of the analysis may have limited the interpretation of the results, as the trials were not powered for the exploratory endpoints examined. Patients with active, severe lupus nephritis or severe neuropsychiatric SLE were not included. Additionally, the study did not include any individuals with lived experience of SLE at any stage of its design, conduct, or reporting.
DISCLOSURES:
This study was funded by AstraZeneca. One author reported receiving honorarium and consulting fees from various pharmaceutical companies and other sources, including AstraZeneca. Another author reported receiving consulting fees from AstraZeneca. A few authors reported being current or former employees or holding stocks of AstraZeneca or having other ties with a biotechnology company.
