Shots:
- Did you know that patients living with SLE in the EU face a two- to threefold higher risk of mortality compared to the general population? This stark reality underscores the need for therapies that are not only effective but also easier to administer
- AstraZeneca’s Saphnelo has recently been recommended for approval in the EU as a self-administered, once-weekly pre-filled pen for adults with systemic lupus erythematosus (SLE), used alongside standard therapy, bringing a new level of convenience to patient care
- Pablo Panella, SVP, Global Head Respiratory & Immunology at AstraZeneca, joins us for an insightful discussion on the therapy’s launch strategy across Europe and offers key perspectives from the Phase III TULIP-SC study that shaped this advancement
Saurabh: Congratulations on receiving the EU recommendation for Saphnelo SC in SLE, a remarkable achievement indeed! Could you share insights into the launch strategy for the European market?
Pablo: Thank you, we’re very pleased that Saphnelo has been recommended for approval in the EU as a self-administered once-weekly pre-filled pen for adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.
For context, approximately 70% of SLE patients in Europe who are on biologic therapy for SLE are already receiving a self-administration option. This means a new subcutaneous option for Saphnelo will extend the treatment’s reach, allowing healthcare providers in Europe to offer the clinically meaningful benefits of Saphnelo to a broader group of patients with SLE in a more flexible and convenient way.
More specifically, SLE remains a chronic, complex autoimmune condition with considerable unmet need – and fewer than 1 in 5 patients with SLE currently receive a biologic. Advancements such as self-administration can help improve access to biologic treatments that, when administered intravenously, have demonstrated their ability to reduce the risk of organ damage and adverse outcomes in patients, whilst offering remission as an achievable treatment goal.
We are excited about the potential for subcutaneous Saphnelo to transform care for patients with SLE and, if approved in the EU, we look forward to rolling out the subcutaneous administration of Saphnelo across Europe.
Saurabh: That’s exciting! Could you walk us through the Phase III TULIP-SC study, specifically its trial design, primary endpoints, and key safety findings?
Pablo: TULIP-SC was a Phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous administration of Saphnelo versus placebo in participants aged 18 to 70 years with moderate to severe, active, autoantibody-positive SLE while receiving standard therapy.
In the trial, 367 participants on standard of care treatment were randomised 1:1 to receive a 120mg subcutaneous dose of Saphnelo or placebo administered once-weekly via a pre-filled syringe. A planned interim analysis was conducted when the first 220 participants reached week 52. The trial also included an open-label extension period of 52 weeks for participants who completed the 52-week treatment period.
Most importantly, Saphnelo met the primary endpoint – it reduced disease activity, as measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52 in the interim analysis. It showed the subcutaneous administration demonstrated a statistically significant and clinically meaningful reduction in SLE disease activity compared to placebo. The positive BICLA result in TULIP-SC is consistent with results from previous trials of Saphnelo intravenous (IV) infusion. Also, the safety profile seen in the interim analysis was consistent with the known clinical profile of Saphnelo administered as an IV infusion.
Saurabh: From your perspective, what are the current unmet needs in SLE management, and how does Saphnelo address these therapeutic gaps?
Pablo: SLE is a debilitating autoimmune condition that can impact every aspect of a patient’s life, primarily affecting women often from young adulthood. In Europe, people with SLE have a 2-3 times increased risk of death and in the US it’s among the top 10 causes of death among women. Remission is possible, yet due to delays in diagnosis and limited access to treatments, fewer than 10% of people with SLE currently achieve remission.
Saphnelo is a first-in-class biologic that targets the type I interferon (type I IFN) pathway, which has been shown to reduce long-term organ damage compared to standard therapy – and importantly, since its introduction, achieving DORIS remission has become possible for many more SLE patients.
Alongside this, we’ve also seen a paradigm shift in treatment guidelines, including recent updates to recommendations from the American College of Rheumatology and European Alliance of Associations for Rheumatology, which now elevate the importance of treating to target remission or low disease activity and minimising the use of oral corticosteroid.
This positive CHMP opinion is a big step in our ambition to transform the care of immune-mediated diseases for patients by moving beyond symptom control to long-term remission and one day, cure.
Saurabh: Reports indicate that patients with SLE in the EU have a two- to threefold higher mortality risk compared to the overall population. What factors contribute to this elevated risk, and how can these challenges be better managed?
Pablo: The heterogeneous symptoms of SLE can often delay diagnosis, meaning patients can endure years of unpredictable flares, disease progression and early damage accrual in different organs. Patients with SLE often rely on prolonged use of oral corticosteroids that offer relief from symptoms, but they do not provide optimal control on causal disease mechanisms or offer continuous disease control.
Around 50% of people with SLE have irreversible organ damage within 5 years of diagnosis due to long-term corticosteroid use, disease flares, and persistent disease activity. Patients who accumulate early organ damage face a higher risk of early- and long-term complications, and as a result, uncontrolled disease activity results in significant physical, economic and social costs. Early and sustained control of SLE activity can prevent organ damage, ultimately leading to better outcomes and reduced financial strain on healthcare systems.
The subcutaneous administration of Saphnelo has significant potential to drive impact for patients as it offers greater flexibility and convenience to a wider group of patients. We expect biologic usage in the lupus market to grow similarly to other immune-driven inflammatory diseases such as rheumatoid arthritis, Crohn’s disease or psoriasis, driven by effective treatments. Biologics use among eligible patients (bio-pen) for other immune-driven inflammatory diseases—such as rheumatoid arthritis, Crohn’s disease, and psoriasis—can reach up to 60%.
Since launch, more than 40,000 patients globally have been treated with Saphnelo IV infusion, which reflects rheumatologists’ growing acknowledgement in its value in achieving SLE treatment goals.
Saurabh: Is AstraZeneca currently investigating Saphnelo SC for other autoimmune or inflammatory conditions? If so, could you share more about those programs?
Pablo: We are exploring the potential of Saphnelo in a variety of diseases in which type I interferon (IFN) plays a key role, including lupus nephritis (IRIS Ph3 trial), cutaneous lupus erythematosus (LAVENDER Ph3 trial, scleroderma (DAISY Ph3 trial) and idiopathic inflammatory myopathies (JASMINE Ph3 trial).
We also continue to study Saphnelo in other patient populations; in July 2025, it was announced that Saphnelo met its primary endpoint in the AZALEA study in China, demonstrating a statistically significant and clinically meaningful improvement in BICLA Response at week 52, compared to placebo, in Asian patients with moderate to severe SLE on top of standard therapy.
Saurabh: Is AstraZeneca exploring collaborations or partnerships to enhance the market accessibility of Saphnelo SC in other regions? If yes, we’d love to hear more about those efforts.
Pablo: As with all our medicines, we want to help make sure that patients who are prescribed our medicines have access to them. For patients who may have difficulty paying for the subcutaneous administration of Saphnelo, AstraZeneca offers patient assistance programs and assistance with coverage and reimbursement processing and programs.
About the Author
Pablo Panella
Senior Vice President, Global Respiratory & Immunology, AstraZeneca
Pablo was appointed Senior Vice-President, Global Respiratory & Immunology (R&I) in 2020 and is responsible for AstraZeneca’s global R&I business and strategy for the Company’s current and future R&I portfolio of medicines. AstraZeneca is an established leader in chronic respiratory diseases and is expanding now into other Immune-mediated diseases with a portfolio of novel inhaled therapies, novel small molecules and biologics as well as new modalities, including cell therapy.
Prior to his current role Pablo was Senior Vice-President of the Western and Southern Europe Area (WESE), responsible for a cluster of 9 European countries and in charge of Europe and Canada’s Regional Commercial teams.
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