AstraZeneca’s Saphnelo (anifrolumab) has demonstrated strong results for the treatment of systemic lupus erythematosus (SLE). 

In the Phase III TULIP-SC trial, 56.2% of patients who received Saphnelo via subcutaneous (SC) self-administration achieved a reduction in disease activity at Week 52 versus 37.1% receiving placebo, as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA). The safety profile observed in the TULIP-SC trial was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion. 

Results from the TULIP-SC trial, published in Arthritis & Rheumatology, indicate Saphnelo enabled OSC reduction while maintaining clinical response in a key secondary endpoint. 

“These meaningful results from the TULIP-SC trial provide confidence that the efficacy and DORIS-defined remission rates that we’ve seen with anifrolumab can be achieved in a new subcutaneous administration, allowing even more patients to benefit from this effective treatment,” said Susan Manzi, Chair of the Allegheny Health Network (AHN) Medicine Institute, Director of the Lupus Center of Excellence at the AHN Autoimmunity Institute and Principal Investigator of the TULIP-SC trial. 

“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.” 

Saphnelo could help ‘transform lupus care’

Patients with SLE have a higher risk of early death, with an estimated 50% having irreversible organ damage within five years of diagnosis due to disease activity and chronic oral corticosteroid (OCS) use. Lowering disease activity while reducing OCS use reduces the risk of long-term organ damage and helps patients avoid the debilitating effects of the disease. 

“These results reinforce Saphnelo’s unique approach of targeting the type 1 interferon receptor to reduce disease activity, with the added convenience of subcutaneous self-administration,” added Sharon Barr, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca. 

“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 IV infusion is currently approved for the treatment of moderate to severe SLE in more than 70 countries worldwide including the US, EU and Japan, with regulatory reviews ongoing in other countries including China. SC administration of Saphnelo is approved in the EU and is under regulatory review in several countries around the world, including the US and Japan. 

Bruno Quinney, Content Team, DDW