Pre-specified interim analysis of the randomised Phase III TULIP-SC study has demonstrated that subcutaneous (SC) administration of AstraZeneca’s fully human monoclonal antibody, Saphnelo (anifrolumab), has reduced disease activity in individuals with systemic lupus erythematosus (SLE), against a placebo.
The double-blind, placebo-controlled multi-centre trial assessed the safety and efficacy of SC anifrolumab in those with moderately to severely active autoantibody-positive SLE.
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Subjects in the trial, aged between 18 and 70 years, were undergoing standard therapy and were additionally administered either a 120mg dose of the antibody or a placebo once a week using a prefilled syringe.
The planned interim analysis took place after the first 220 subjects completed 52 weeks of treatment.
It showed that the safety profile of the SC administration of the antibody aligns with the profile observed in intravenous (IV) infusions.
The study also features a subsequent open-label extension duration for those who finish the initial 52-week treatment phase.
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By GlobalDataThe decrease in the disease activity was gauged via the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at the mark of week 52, which needs improvement across all affected organs without new flares.
These interim findings are currently being reviewed by regulatory bodies and will be presented at the American College of Rheumatology Convergence 2025 annual meeting.
AstraZeneca BioPharmaceuticals research and development (R&D) executive vice-president Sharon Barr said: “The TULIP-SC results are especially important because approximately half of systemic lupus erythematosus patients today taking a biologic are already treated with a self-administered SC option.
“With Saphnelo, we hope to establish remission as an achievable treatment goal for more patients, and we are actively working with regulatory authorities to bring this new administration option to patients as soon as possible.”
Saphnelo IV gained approval in more than 70 nations to treat moderate to severe SLE and continues to undergo regulatory evaluations in other regions.
AstraZeneca obtained the global rights to Saphnelo via an exclusive licensing and partnership agreement with Medarex in 2004.
Earlier this month, AstraZeneca’s Tagrisso (osimertinib) demonstrated a significant improvement in overall survival in the FLAURA2 Phase III trial for non-small cell lung cancer (NSCLC) when used alongside pemetrexed and platinum-based chemotherapy.
