Long-term benefit of anifrolumab in SLE: post-hoc analyses of phase III TULIP-LTE

The Lupus Hub has previously reported results from the phase III TULIP- long-term extension (LTE) study (NCT02794285), outlining the safety and efficacy of anifrolumab vs placebo in patients with systemic lupus erythematosus (SLE).

Here, we summarize post-hoc analyses of the TULIP-LTE trial presented at the American College of Rheumatology (ACR) annual meeting (ACR Convergence 2023).

Study design

Adults with moderate-to-severe SLE completing the 52-week phase III TULIP-1/TULIP-2 trials reconsented to enroll in the randomized, placebo-controlled, double-blind LTE trial.

From Week 52 through Week 208, the outcomes assessed were:

• overall and organ-specific Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) improvements¹;
• SLEDAI-2K renal improvement²;
• patient-reported outcomes by the Short Form 36 Health Survey Version 2³; and
• attainment of Definition of Remission in SLE (DORIS).⁴

Key findings

At Week 208, anifrolumab vs placebo was associated with a:

• higher proportion of patients achieving ≥4 point reduction in overall SLEDAI-2K (Figure 1) and individual organ domains¹;
• higher proportion of patients achieving renal improvement, with or without SLEDAI-2K renal involvement at baseline (Figure 1)²;
• higher proportion of patients responding to physical and mental component scores (Figure 1), and Short Form 36 Health Survey Version 2 domains³; and
• shorter time to first DORIS remission (median 13.5 vs 15.0 months; p = 0.0338) and increased DORIS remission attainment (Figure 1).⁴