Subcutaneous anifrolumab beneficial in systemic lupus erythematosus

Administering anifrolumab shots in addition to standard therapy is safe and yields clinically meaningful benefits in moderate to severe systemic lupus erythematosus, according to the phase III TULIP-SC trial.

TULIP-SC included adult patients with SLE who were randomly assigned to receive subcutaneous anifrolumab 120 mg or placebo once weekly for 52 weeks. The primary endpoint of BILAG-based Composite Lupus Assessment [BICLA] response at 52 weeks was formally tested in a preplanned interim analysis. Secondary and other endpoints were tested in the full analysis.

The interim analysis involved 220 patients, of which 109 were in the anifrolumab group and 111 in the placebo group. The full analysis set included 367 patients, of which 184 were in the anifrolumab group and 183 in the placebo group.

Interim analysis showed that more patients in the anifrolumab group than in the placebo group achieved the primary endpoint of BICLA response at 52 weeks (59.4 percent vs 43.9 percent; difference, 15.5 percent, 95 percent confidence interval [CI], 2.3–28.6; p=0.0211).

In the full analysis, anifrolumab was associated with a higher BICLA response while maintaining low/reduced oral glucocorticoid doses through week 52 (56.2 percent vs 34 percent; difference, 22.3 percent, 95 percent CI, 12.3−32.2; p<0.0001). Furthermore, the time to first sustained BICLA response was significantly reduced with anifrolumab vs placebo (hazard ratio [HR], 2.2, 95 percent CI, 1.5−3.2; p<0.0001).

Compared with placebo, anifrolumab was also associated with significantly higher rates of DORIS remission (difference, 14.2 percent, 95 percent CI, 5.6−22.8; p=0.0012) and Low Lupus Disease Activity State (difference, 14.1 percent, 95 percent CI, 4.6−23.6; p=0.0038).

Serious adverse events occurred in 11.9 percent of patients treated with anifrolumab and in 10.4 percent of those on placebo. The respective rates of herpes zoster were 3.8 percent and 1.1 percent.