AstraZeneca's Self-Injected Saphnelo Cuts Lupus Activity in Full Phase 3 TULIP-SC Results

AstraZeneca said on January 6 that full results from the Phase 3 TULIP-SC trial showed a once-weekly self-injected form of its lupus drug Saphnelo (anifrolumab) reduced disease activity in systemic lupus erythematosus (SLE) significantly more than placebo, according to the company's announcement. The company said the results were published in the journal Arthritis & Rheumatology.

Saphnelo has been sold since 2021 as an intravenous infusion given in a hospital or clinic. AstraZeneca said the infusion is approved for moderate to severe SLE in more than 70 countries, including the US, EU and Japan. The subcutaneous version, given with a pre-filled single-use syringe, was approved in the EU in December 2025 and is under regulatory review in several countries, including the US and Japan, the company said.

What the trial found

TULIP-SC was a randomized, double-blind, placebo-controlled Phase 3 trial in 367 adults aged 18 to 70 with moderately to severely active, autoantibody-positive SLE. Participants received either 120 mg of subcutaneous anifrolumab or placebo, on top of standard therapy such as oral corticosteroids, antimalarials or immunosuppressants.

The primary endpoint was the share of patients who achieved a response on the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52. In the full analysis, 56.2% of patients on Saphnelo responded, compared with 37.1% on placebo, a difference of 19.1 percentage points (p=0.0002), AstraZeneca reported. An earlier, pre-specified interim analysis of the first 220 participants had also been statistically significant, with 59.4% versus 43.9% responding.

On key secondary endpoints, 56.2% of patients on Saphnelo were BICLA responders who kept oral corticosteroid doses low or reduced from week 40 to week 52, compared with 34.0% on placebo. Time to a sustained BICLA response also favored the drug. Time to first flare over 52 weeks was numerically delayed but did not reach statistical significance (p=0.0798), according to the company's results table.

In pre-specified secondary and exploratory measures, 29.0% of patients on Saphnelo reached remission under the DORIS definition, against 14.7% on placebo, and 40.1% reached low-level disease activity as measured by the Low-Level Disease Activity Score (LLDAS), against 26.0%. AstraZeneca noted that those p-values are nominal and not adjusted for multiple comparisons.

Safety and next steps

The company said subcutaneous Saphnelo was well tolerated, adverse events were balanced between the two groups, and the safety profile was consistent with the intravenous form. The trial includes a 52-week open-label extension for participants who completed the main treatment period.

"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," said Susan Manzi, the trial's principal investigator and director of the Lupus Center of Excellence at the Allegheny Health Network Autoimmunity Institute, in the release.

The results were reported by AstraZeneca and in the journal publication; trade outlet Indian Pharma Post carried the same figures on January 7. AstraZeneca licensed global rights to the drug from Medarex in 2004 and pays a royalty to Bristol-Myers Squibb, which later acquired Medarex, the company said.