Anifrolumab shows higher remission rates versus placebo in SLE patients regardless of immunosuppressant history

This post hoc analysis pooled data from two Phase 3 randomized controlled trials (TULIP-1 and TULIP-2) involving 726 patients with moderate-to-severe systemic lupus erythematosus. Patients were stratified by prior immunosuppressant (IS) exposure: 257 were IS-inexperienced (anifrolumab n=127, placebo n=130) and 469 were IS-experienced (anifrolumab n=233, placebo n=236). All received intravenous anifrolumab 300 mg or placebo alongside standard therapy, with outcomes assessed at week 52.

For the Definition of Remission in SLE (DORIS) outcome, remission rates were significantly higher with anifrolumab versus placebo in both subgroups. Among IS-inexperienced patients, 16.2% achieved DORIS remission with anifrolumab versus 6.0% with placebo (p=0.0242). Among IS-experienced patients, rates were 14.6% versus 7.3% (p=0.0304). For Lupus Low Disease Activity State (LLDAS) attainment, the difference reached statistical significance only in the IS-experienced group (27.7% vs 16.2%, p=0.0038), while the IS-inexperienced group showed a non-significant numerical advantage (34.0% vs 26.2%, p=0.1718).

Safety data were limited but indicated anifrolumab was well tolerated regardless of IS history, with a more favorable safety profile observed among IS-inexperienced patients compared to IS-experienced patients. Specific adverse event rates, serious adverse events, and discontinuation data were not reported.

Key limitations include the post hoc, exploratory nature of the analysis and the use of nominal p-values without adjustment for multiple comparisons. The primary outcome of the original trials was not reported here, and safety details are incomplete. For practice, this analysis suggests anifrolumab may offer benefit in achieving remission and low disease activity in moderate-to-severe SLE patients with or without prior immunosuppressant use, but these findings require confirmation in prospectively designed studies.