TULIP-LTE: Long-term effect of anifrolumab on patient-reported outcomes in SLE

Patient-reported outcomes (PROs) are valuable when monitoring patients with systemic lupus erythematosus (SLE), where symptoms such as fatigue, pain, and reduced physical functioning may not be reflected adequately by conventional disease activity indices.

The phase III TULIP long-term extension (TULIP-LTE) study (NCT02794285) was a 3-year randomized, double-blind, placebo-controlled extension of the 1-year TULIP-1 and TULIP-2 trials of anifrolumab in patients with SLE. Changes in health-related quality of life were captured across multiple validated instruments in TULIP-LTE to establish the effects of anifrolumab treatment alongside standard therapy over a 4-year treatment period (n = 369). Findings were published by Strand et al. in Lancet Rheumatology. 

Key learnings

At Week 208, patient-reported improvements from baseline were numerically higher with anifrolumab vs placebo in SF-36v2 domains for bodily pain (LS mean difference: 5.9 [95% CI: −0.7 to 12.5]) and mental health (LS mean difference: 3.7 [95% CI: −1.2, 8.6]).

In patients maintaining glucocorticoid doses ≤5.0 mg/day, the LS mean change from baseline in the SF-36v2 bodily pain domain was 13.9 with anifrolumab vs 6.2 with placebo (LS mean difference: 7.7 [95% CI: −1.9, 17.3]).

SF-6D utility index scores were generally numerically greater with anifrolumab vs placebo with differences evident from Week 24 (LS mean difference: 0.013 [95% CI: −0.007, 0.032]) and maintained at Week 208 (0.016 [95% CI: −0.010, 0.042]).

Patients with chronic, progressive diseases such as SLE benefit from therapies that address both disease activity and quality of life; these 4-year data provide new insights into the potential long-term impact of treatment and suggest that anifrolumab is an effective treatment option that can positively impact PROs beyond standard therapy alone.