Anifrolumab Promising for Sustained Low Disease Activity in Patients with Lupus

The Results

At week 52, 114 patients (13.9%) achieved LLDAS. Of these 114 patients, 102 (89.5%) were also BICLA responders. This analysis also included patients in the TULIP-1 trial who received 150 mg of anifrolumab, as well as a group of patients who received 300 mg of anifrolumab. Of the BICLA responders, 102 of 318 (32%) achieved LLDAS at week 52. More patients achieved LLDAS as the 52-week trial continued, and LLDAS was achieved earlier in the trial by patients treated with 300 mg of anifrolumab than by those treated with placebo.

Also at week 52, 17.5% of patients who received anifrolumab and 10.6% of patients who received placebo achieved LLDAS. Patients who received anifrolumab had more cumulative time (P<0.001) and percentage of time (P<0.001) in LLDAS than patients who received placebo. The cumulative time in LLDAS thresholds of at least 20% (odds ratio [OR] 1.8, 95% confidence interval [CI] 1.2–2.7; P=0.004) and at least 50% (OR 1.9, 95% CI 1.0–3.4; P=0.035) also favored patients treated with anifrolumab.

Patients treated with anifrolumab were more likely to sustain LLDAS for at least three consecutive visits (18.6%) than patients who received placebo (12.5%). Additionally, they were more likely to sustain LLDAS for at least five consecutive visits (11.2%) or at least seven consecutive visits (6.8%) than patients who received placebo (7.7% and 2.7%, respectively). 

This analysis of phase 3 clinical data of anifrolumab showed that LLDAS is an attainable treat-to-target end point in lupus clinical trials, and LLDAS is more stringent than BICLA. Treatment with anifrolumab led to earlier, and more frequent and sustained, LLDAS response.

References

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