CONFERENCE UPDATE: EULAR 2023

Anifrolumab leads to earlier and sustained attainment of LLDAS in patients with moderate-to-severe SLE

RHEUMATOLOGY
03 Jul 2023

STUDY DESIGN

The lupus low disease activity state (LLDAS) is an endpoint that is prospectively validated as protective from flares, damage accrual, and mortality.1 It is an important treatment goal in patients with systemic lupus erythematosus (SLE).1 In the previous TULIP-1 and TULIP-2 trials, LLDAS was attained earlier and more frequently, and was more sustained among patients receiving anifrolumab vs. placebo.1 In a long-term extension (LTE) to TULIP, anifrolumab 300mg had an acceptable long-term safety profile and maintained reduction in disease activity and glucocorticoid use.1 Monitoring LLDAS attainment over the TULIP and TULIP-LTE study periods was an important step for understanding the long-term impact of anifrolumab on the SLE management.1

In TULIP-1 and TULIP-2, adult patients with moderate-to-severe SLE despite receiving the standard therapy were randomized to receive anifrolumab 300mg, anifrolumab 150mg, or a placebo intravenously (IV) every 4 weeks (Q4W).1 After 52 weeks of treatment, patients could enroll in the LTE, with the former anifrolumab groups continued to receive anifrolumab 300mg, while the placebo group was randomized 1:1 to receive either anifrolumab 300mg or remain on placebo.1 In this case, the approximate ratio of anifrolumab to placebo was 4:1 in the LTE.1 In accordance with the post hoc analysis, data from the TULIP baseline towards the end of the LTE (week 208) were analyzed for patients who received the same study drug throughout the study periods.1

The results showed that anifrolumab was more effective in earlier attainment of LLDAS and had a longer duration of low disease activity states compared with placebo.1 Patients receiving anifrolumab also spent more consecutive time in LLDAS than patients receiving placebo, demonstrating a more sustained effect on LLDAS.1 Moreover, the long-term safety profile of anifrolumab was also acceptable and reduction in glucocorticoid usage was maintained over time.1

FINDINGS

 Primary endpoints:
  • The primary endpoints were the time to first LLDAS and the cumulative time in LLDAS1
  • The anifrolumab group had an earlier time to first LLDAS compared with placebo (HR=1.6; 95% CI: 1.2-2.1; p=0.0024)1
  • The response rates at week 208 were 36.9% and 17.1% for the anifrolumab and placebo groups, respectively1

 Secondary endpoints:
  • The secondary endpoints were the percentage of time spent in LLDAS and the consecutive time spent in LLDAS1
  • The percentage of time spent in LLDAS in the anifrolumab group was higher than that in the placebo group (30.71% ± 2.109% vs. 20.71% ± 2.909%), with the LS mean difference of 10.01% (95% CI: 3.92-16.09; pnominal=0.0013)1
  • The proportion of patients spending ≥20% of time in LLDAS was significantly higher in the anifrolumab group than placebo (OR=2.1; 95% CI: 1.3-3.4; pnominal=0.0014)1
  • Patients treated with anifrolumab were more likely to achieve sustained LLDAS compared with placebo for ≥3, ≥5, ≥7, and ≥9 consecutive monthly visits1

 Safety:
  • An acceptable long-term safety profile of anifrolumab was established1
  • Reduction in glucocorticoid use was maintained

 

"The improvements in LLDAS attainment seen with anifrolumab compared with placebo in a post hoc analysis of pooled TULIP data had been maintained for over 3 more years of treatment during the LTE period"

Professor Eric F. Morand
Monash University,
Centre for Inflammatory Diseases,
Melbourne, Australia

 

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