A new phase 3 clinical trial found that a weekly injection of anifrolumab, added to standard therapy, helped more adults with moderate to severe lupus achieve better disease control compared to placebo.
The study included 367 adults with systemic lupus erythematosus (SLE) who still had active disease despite standard treatments. Participants were randomly assigned to receive either a 120 mg subcutaneous injection of anifrolumab once weekly or a placebo. The main goal was to see how many people had a BICLA response at 52 weeks, which measures improvement in lupus symptoms.
Results showed that 59.4% of those on anifrolumab achieved a BICLA response at the interim analysis, compared to 43.9% on placebo. In the full analysis, more people on anifrolumab also maintained low or reduced steroid doses while achieving response. The drug also led to higher rates of remission and low disease activity. However, herpes zoster infections were more common with anifrolumab (3.8% vs 1.1%). Serious side effects were similar between groups.
This is a randomized controlled trial, so the results are reliable. But the study was funded by the drugmaker, and long-term safety data are still needed. For people with lupus that is not well controlled, this treatment may offer a new option, but it is not yet approved for this use.