AstraZeneca PLC (LSE:AZN) has reported positive results from a late-stage study of Saphnelo, its treatment for systemic lupus erythematosus (SLE), showing the drug was effective when given as a self-administered injection under the skin.
The phase III TULIP-SC trial met its main goal at an interim analysis, demonstrating that patients receiving subcutaneous Saphnelo had a statistically significant and clinically meaningful reduction in disease activity compared with placebo.
The safety profile was in line with the intravenous version already in use.
SLE is an autoimmune condition that affects more than 3.4 million people worldwide. It can damage multiple organs and is often treated with oral corticosteroids, which provide only short-term relief and carry significant side effects.
Clinical guidelines increasingly stress the importance of lowering steroid use and aiming for remission or low disease activity, but options remain limited.
Dr Susan Manzi, principal investigator of the trial, said: “Today’s results for subcutaneous anifrolumab reinforce the efficacy and safety of this therapy and provide the opportunity for this important biologic to reach a wider group of patients in a more flexible and convenient way.”
The interim findings will be presented at the American College of Rheumatology conference in October. Saphnelo is already approved as an intravenous infusion in more than 70 countries, with more than 38,000 patients treated to date.