FDA approval for anifrolumab in patients with lupus

On July 30, 2021, the US Food and Drug Administration (FDA) issued its first new drug approval for systemic lupus erythematosus (SLE) in more than a decade. Approval of the drug—anifrolumab, a type 1 interferon receptor antagonist—was based on two phase 3 trials, TULIP-1 and TULIP-2. TULIP-2 involved 362 patients with moderate-to-severe SLE who had failed at least one first-line therapy. Patients who received intravenous anifrolumab (n=180) were significantly more likely to achieve an overall decrease in disease activity than those in the placebo group (n=182). The drug was well-tolerated and was associated with reduced use of steroids. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trialThe primary endpoint was not reached. However, several secondary endpoints, including reduction in oral corticosteroid dose, CLASI responses, and BICLA responses, suggest clinical benefit of anifrolumab compared with placebo. Conclusive evidence for the efficacy of anifrolumab awaits further phase 3 trial data. Despite the inherent limitations of a 1-year phase 3 study, such as incomplete knowledge of applicability to the general population and scarce detection of rare safety signals, in addition to complications from prespecified restricted medication rules, our results suggest that anifrolumab might have the potential to provide a treatment option for patients who have active SLE while receiving standard therapy. Full-Text PDF