Saphnelo (anifrolumab-fnia) / BMS, AstraZeneca - LARVOL DELTA

In Q4 2025, AstraZeneca paid BristolMyers Squibb Company (BMS) $170m, expensed in Cost of sales, in exchange for the reduction to zero of all royalties payable on Saphnelo sales ex-US. (AstraZeneca Press Release) - "Royalties on US sales will remain payable at a mid-teens percentage."

Commercial • Systemic Lupus Erythematosus

Patient profiles and early response in patients with systemic lupus erythematosus initiating anifrolumab: interim analysis from the ongoing multicentre observational REVEAL study. (PubMed, Lancet Rheumatol) - P | "This study provides the first large-scale real-world evidence of anifrolumab use in patients with SLE, supporting its clinical benefit and rapid onset of action in routine care."

Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Rheumatology • Systemic Lupus Erythematosus • IFNAR2

Rapid remission and effect on organ manifestations with anifrolumab. (PubMed, Lancet Rheumatol) - No abstract available

Journal

Response to correspondence on 'Anifrolumab in childhood-onset systemic lupus erythematosus: a promising option after belimumab failure' by Argüelles Balas et al. (PubMed, Ann Rheum Dis) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Correspondence on 'Anifrolumab in childhood-onset systemic lupus erythematosus: a promising option after belimumab failure' by Argüelles Balas et al. (PubMed, Ann Rheum Dis) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

What's New in Cutaneous Lupus Erythematosus: Guidelines, Biologics, and Beyond. (PubMed, J Clin Aesthet Dermatol) - "Ongoing therapeutic innovation, guided by mechanistic insights and strengthened by the development of standardized outcome measures, is transforming the CLE landscape and advancing the goal of precision-based, durable disease control."

Journal • Review • CNS Disorders • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Rheumatology • Systemic Lupus Erythematosus

Real-world use of anifrolumab in refractory cutaneous lupus: case series and review of the literature. (PubMed, J Dtsch Dermatol Ges) - No abstract available

Journal • Real-world evidence • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

AstraZeneca Seeks Green Light to Sell New Lupus Drug Anifrolumab in China (Yicai Global) - "Recent Phase III clinical trial results for anifrolumab showed that, among Asian adults with moderate to severe SLE, the drug delivered statistically and clinically meaningful improvements compared with a placebo, Cambridge-based AstraZeneca said."

China filing • Systemic Lupus Erythematosus

A Phase IIb, open label, Randomised Trial within Cohort (TwiC) of IV Anifrolumab in Adults with Systemic Sclerosis. The REASCENT study (SSWC 2026) - No abstract available

Clinical • P2b data • Immunology • Scleroderma • Systemic Sclerosis

REAL-WORLD EVIDENCE PREVALENCE AND CLINICAL OUTCOME OF PATIENTS MEETING THE INCLUSION CRITERIA OF THE PHASE 3 TRIAL DAISY (DETECTING EFFECTIVENESS OF ANIFROLUMAB IN SSC) - A EUSTAR COHORT STUDY (SSWC 2026) - No abstract available

Clinical • Clinical data • HEOR • P3 data • Real-world • Real-world evidence

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) (clinicaltrials.gov) - P3 | N=314 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Scleroderma • Systemic Sclerosis

Case Report: Relapsing systemic lupus erythematosus treated with dual rituximab and anifrolumab therapy. (PubMed, Front Med (Lausanne)) - "Anifrolumab was reintroduced while she remained on rituximab, leading to significant clinical improvement of her cutaneous symptoms. To our knowledge, we present the first case of successful treatment of refractory SLE with both cutaneous and neurologic involvement utilizing dual biologic therapy with rituximab and anifrolumab."

Journal • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • Vascular Neurology

Immunology : what's new in 2025 (PubMed, Rev Med Suisse) - "Among therapeutic advances in systemic autoimmune diseases, obinutuzumab, when added to the standard of care, has proved effective in treating active lupus nephritis, anifrolumab has confirmed its long-term benefits in treating systemic lupus erythematosus (SLE), new drugs such as telitacicept and ianalumab have passed phase III trials, and T-cell engagers show promise in controlling refractory autoimmune diseases. Finally, cardiovascular risk scores (Systematic COronary Risk Evaluation - SCORE2, QRESEARCH risk estimator version 3 - QRISK3, Predicting Risk of Cardiovascular Disease Events - PREVENT), which were developed for the general population, were specifically evaluated in SLE, given its particularly high burden of cardiovascular events."

Journal • Cardiovascular • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rheumatology • Systemic Lupus Erythematosus

Thrombotic thrombocytopenic purpura in a patient with systemic lupus erythematosus after anifrolumab: a possible association. (PubMed, Arch Clin Cases) - "The patient received plasma exchange, corticosteroids, caplacizumab, and rituximab, resulting in full neurologic and hematologic recovery. Clinicians should remain vigilant for new cytopenia or neurologic symptoms in patients starting interferon-pathway-targeted biologic therapy. Further pharmacovigilance is required to determine whether this represents a coincidental occurrence or a signal of potential risk."

Journal • CNS Disorders • Epilepsy • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura • IFNAR2

A clinically validated assay for rapid determination of type I and type II interferon activity in systemic inflammatory diseases. (PubMed, J Allergy Clin Immunol) - "Flow cytometry analysis of CD169 and CD274 is an effective method to rapidly quantify IFN-I and IFN-γ activity in the clinical setting."

IO biomarker • Journal • Dermatomyositis • Idiopathic Arthritis • Immunology • Inflammation • Inflammatory Arthritis • Interferonopathies • Lupus • Myositis • Rheumatology • Systemic Lupus Erythematosus • IFNG • PD-L1 • SIGLEC1

Anifrolumab for Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: University of North Carolina, Chapel Hill | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Apr 2026 | Trial primary completion date: Jun 2026 ➔ Jan 2026

Enrollment closed • Trial completion date • Trial primary completion date • Acne Vulgaris • Dermatology • Hidradenitis Suppurativa • Immunology

The US Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for Saphnelo (anifrolumab) for subcutaneous administration in adult patients with systemic lupus erythematosus (SLE) (AstraZeneca Press Release) - "AstraZeneca subsequently provided the information requested in the CRL and is committed to working with the FDA to progress the application as quickly as possible. A decision from the FDA on the updated application for Saphnelo SC is expected in the first half of 2026....The original BLA submitted to the FDA by AstraZeneca was based on a planned interim analysis of the Phase III TULIP-SC trial evaluating the subcutaneous administration of Saphnelo, which met the primary endpoint."

CRL • FDA event • Systemic Lupus Erythematosus

BXSB.Yaa: A Translational Model of Toll-Like Receptor 7-Type I Interferon-Driven Systemic Lupus Erythematosus. (PubMed, Immunology) - "Despite recent approvals of belimumab and anifrolumab, durable, steroid-sparing remission in systemic lupus erythematosus (SLE) remains uncommon, underscoring ongoing therapeutic needs. We synthesise insights from BXSB.Yaa studies, including those that informed FDA-approved biologics, and discuss implications for next-generation precision therapies. Collectively, we advocate for BXSB.Yaa as an essential pre-clinical platform among complementary models to accelerate mechanism-based drug development and enable stratified translation in SLE research."

Journal • Review • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IFNG • TLR5 • TLR7

Glucocorticoid-Free Induction Therapy With Hydroxychloroquine and Anifrolumab in Systemic Lupus Erythematosus: A Case Report. (PubMed, Cureus) - "ANI is a monoclonal antibody targeting the type I interferon receptor subunit 1 and can be a key drug for SLE. The findings suggest that GC-free induction therapy can be an approach for controlling disease activity in SLE."

Journal • Dermatology • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Leukopenia • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus • Thrombocytopenia • IFNAR2

Type I interferon endotypes drive divergent clinical trajectories in childhood-onset SLE uncovered through a novel systems immunology approach. (PubMed, Ann Rheum Dis) - "Multilevel IFN profiling revealed an important biomarker of IFN-high patients for potential use in clinical practice, immune lineage-specific responses, and clinically meaningful endotypes, supporting systems immunology approaches and biomarker-guided personalised treatment strategies."

Journal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD63 • IFNA1 • LAMP3

Rapid clinical response in refractory discoid lupus erythematosus treated with anifrolumab. (PubMed, An Bras Dermatol) - No abstract available

Journal • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

Efficacy of anifrolumab in recurrent diffuse alveolar hemorrhage associated with systemic lupus erythematosus. (PubMed, Med Clin (Barc)) - No abstract available

Journal • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

HIV-1 derived oligonucleotides induce a type I IFN/STING dependent immune suppression reversible by targeting IFNARI. (PubMed, PLoS Pathog) - "Targeting IFNAR1 with anifrolumab restored the immune functions of both DCs and T cells, as well as T cell proliferation and T cell effector functions, including their secretion of IL-2, IFNγ, and granzyme B. Our findings support that the immune impairments existing in untreated or antiretroviral therapy (ART) treated HIV-infected individuals are mediated, if not fully in part by type I IFN's negative effect on DC and T cells. Therapeutics targeting IFNα/β receptors, such as anifrolumab, hold potential as combination treatment alongside ART, to achieve a more complete immune restoration and contribute to improved quality of life among people living with HIV."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4 • GZMB • IFI16 • IFNA1 • IFNAR1 • IFNG • STING

The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Atherosclerosis • Cardiovascular • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

DAHLIA: Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. (clinicaltrials.gov) - P=N/A | N=218 | Recruiting | Sponsor: AstraZeneca

New trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus