Phase III TULIP-SC Trial Confirms Subcutaneous Saphnelo’s Efficacy in Lupus

Phase III TULIP-SC Trial Confirms Subcutaneous Saphnelo’s Efficacy in Lupus

By, Admin 8 January 2026

AstraZeneca has reported positive full results from the phase III TULIP-SC trial, showing that subcutaneous (SC) Saphnelo (anifrolumab) significantly reduces disease activity in patients with systemic lupus erythematosus (SLE).

The full analysis was published in Arthritis & Rheumatology and confirms earlier interim findings.

Key Efficacy Results at Week 52

Subcutaneous Saphnelo met its primary endpoint.

BICLA response at Week 52:

  • 56.2% with Saphnelo
  • 37.1% with placebo
  • Absolute difference: 19.1%
  • p-value: 0.0002

These results align with prior intravenous (IV) Saphnelo trials.

Why This Matters for Lupus Care?

SLE remains a high-burden disease.

  • Patients face early mortality risk
  • Around 50% develop irreversible organ damage within five years
  • Long-term oral corticosteroid (OCS) use is a key driver of damage

Reducing disease activity while tapering steroids is now a central treatment goal.

Alignment With New Treatment Guidelines

Recent lupus guidelines now prioritise:

  • DORIS-defined remission
  • Early biologic intervention
  • OCS tapering toward discontinuation

The TULIP-SC data directly supports this shift.

Secondary and Exploratory Outcomes

Saphnelo showed consistent benefits across multiple endpoints.

Notable findings:

  • 29.0% achieved DORIS remission
  • 40.1% reached low disease activity (LLDAS)
  • Faster BICLA responses
  • Delayed time to first flare
  • Effective disease control while tapering OCS to ≤7.5 mg/day

Safety and Tolerability

The safety profile of subcutaneous Saphnelo matched expectations.

  • Overall adverse events were balanced versus placebo
  • No new safety signals emerged
  • Comparable to the known IV Saphnelo profile

Convenience Advantage: Subcutaneous Administration

Subcutaneous Saphnelo introduces a meaningful shift in care delivery.

What changes for patients:

  • Once-weekly self-administration
  • No mandatory infusion visits
  • Option for home use or caregiver support

This expands access without compromising efficacy.

Regulatory Status

  • IV Saphnelo: Approved in 70+ countries
  • SC Saphnelo: Approved in the EU (December 2025)
  • Under review: US, Japan, and other regions

More than 40,000 patients worldwide have been treated with Saphnelo to date.

About the TULIP-SC Trial

  • Phase III, randomised, double-blind, placebo-controlled
  • 367 patients with moderate-to-severe, autoantibody-positive SLE
  • Weekly 120 mg SC anifrolumab vs placebo
  • Standard therapy allowed in both arms
  • 52-week primary period plus 52-week open-label extension

How Saphnelo Works?

Saphnelo is a first-in-class monoclonal antibody.

  • Targets type I interferon receptor subunit 1
  • Blocks IFN-alpha, IFN-beta, and IFN-kappa signalling
  • Suppresses inflammatory pathways central to SLE

Type I interferon remains one of lupus’ most validated biological drivers.

Bigger Picture for AstraZeneca

Saphnelo anchors AstraZeneca’s Respiratory & Immunology strategy. The company is also evaluating anifrolumab in:

  • Cutaneous lupus
  • Lupus nephritis
  • Myositis
  • Systemic sclerosis

The ambition is clear: move lupus care toward sustained remission.

Bottom Line

The TULIP-SC trial confirms one thing clearly. Saphnelo’s efficacy translates seamlessly from IV to subcutaneous use.

For patients, this means:

  • Proven disease control
  • Fewer steroids
  • Greater flexibility
  • Less dependence on infusion centres

For lupus care, this is not incremental. It is structural progress.

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