Anifrolumab may enhance quality of life in lupus

Patients with systemic lupus erythematosus (SLE) treated with anifrolumab over 4 years appear to report improvements in health status and quality of life, according to data from the TULIP long-term extension trial (TULIP-LTE).

TULIP-LTE included 369 SLE patients (mean age 42.8 years, 92 percent women, 68 percent White) enrolled in the phase III TULIP-1 and TULIP-2 trials who were treated with either anifrolumab 300 mg (n=257) or placebo (n=112) every 4 weeks for 52 weeks. In the extension phase, the patients continued the same treatment for 3 years.

Exploratory endpoints included changes from baseline in patient-reported outcomes—Short Form-36 version 2 acute recall (SF-36v2 [acute]), Patient Global Assessment of disease activity, EuroQoL 5 Dimensions-5 Levels (EQ-5D-5L), and Work Productivity and Activity Impairment-Lupus—and health utility indices (Short-Form 6-Dimension [SF-6D]).

All analyses were performed in the modified intention-to-treat population, which included all randomly assigned patients from TULIP-1 and TULIP-2 who received at least one dose of the same treatment during the long-term extension phase.

Both treatment groups showed improvement in patient-reported outcome scores during the entire 4-year treatment period. At week 208, the improvement in SF-36v2 (acute) scores was nominally higher in the anifrolumab group than the placebo group for the bodily pain domain (least-squares mean difference, 5.9, 95 percent confidence interval [CI], −0.7 to 12.5) and the mental health domain (least-squares mean difference, 3.7, 95 percent CI, −1.2 to 8.6).

Additionally, the anifrolumab group had generally greater SF-6D score improvements compared with the placebo group, with numerical differences emerging as early as week 24 (least-squares mean difference, 0.013, 95 percent CI, −0.007 to 0.032) and maintained through week 208 (least-squares mean difference, 0.016, 95 percent CI, −0.010 to 0.042).