AstraZeneca’s subcutaneous (SC) administration of Saphnelo (anifrolumab) has demonstrated significant reductions in systemic lupus erythematosus (SLE) disease activity in new trial results.
Results from the phase 3 TULIP-SC trial, published in Arthritis & Rheumatology, showed that 56.2% of patients treated with SC Saphnelo achieved disease activity reduction at week 52 of the study. By comparison, 37.1% of patients receiving placebo achieved a similar reduction. Results were measured using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) and were comparable with results from previous trials of Saphnelo.
Susan Manzi, a principal investigator of the TULIP-SC trial, said: “The results align with important changes in global lupus treatment recommendations, which now emphasise earlier intervention with biologics, driving remission and reduced use of oral corticosteroids as key treatment goals.”
The safety profile of SC Saphnelo was found to be consistent with the established profile of intravenous (IV) Saphnelo. The treatment was well tolerated, and patients in the treatment and placebo arms of the study presented a comparable number of adverse events.
SLE is a chronic autoimmune disease where the immune system attacks healthy tissue. More than 3.4 million people globally are affected by the condition, and it is especially common in Asian, Black and Hispanic populations. Symptoms caused by SLE include pain, rashes, fatigue, joint swelling and fever, and around half of SLE patients suffer irreversible organ damage in the five years following diagnosis.
Reducing disease activity in SLE allows patients to reduce chronic use of oral corticosteroids (OCS), which can in turn lower the risk of organ damage.
Sharon Barr, executive vice president, biopharmaceuticals research and development at AstraZeneca, said: “The TULIP-SC findings build on the compelling body of evidence for Saphnelo, which has helped patients achieve remission and significantly reduce reliance on oral corticosteroids – further reinforcing our ambition to transform lupus care.”
Saphnelo as an intravenous treatment is approved for moderate to severe SLE in over 70 countries, including the US, EU and Japan. Saphnelo as a subcutaneous treatment is already approved in the EU and is under regulatory review in multiple countries.