SLE: KOL Insight 
Will novel therapies revolutionise the treatment of SLE?
With the approval of GSK’s Benlysta (belimumab) came the dawn of targeted therapy in the treatment of systemic lupus erythematosus (SLE). Roche’s Rituxan/MabThera (rituximab), now experiencing biosimilar competition in Europe, is also used off-label. Despite these advances significant unmet need remains in the treatment of SLE. Novel products are on the horizon, including anifrolumab (BMZ/AstraZeneca), forigerimod (ImmunPharma) and voclosporin (Aurinia Pharma), but challenges in the development of novel SLE treatments mean that nothing should be taken for granted. Learn how KOLs see the market evolving, and how they expect developers to differentiate their pipeline therapies in KOL Insight: Systemic Lupus Erythematosus (SLE). Twelve North American and European KOLs give their insight on one marketed product, one off-label product and 10 pipeline programmes. KOLs also provide their candid views on the potential for novel mechanisms of action.
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SLE is a highly heterogenic condition, and patients frequently present with an array of clinical manifestations and of varying severity. Do KOLs believe there is a need for conclusive diagnostic tests, and is swift and accurate diagnosis problematic?
The treatment of SLE relies on a wide range of drugs, but unmet needs remain. What do KOLs think of the current armamentarium of treatments, there safety, efficacy and long-term tolerability, and what is the most significant unmet need when it comes to pharmacological intervention?
What does Benlysta (belimumab) bring to the treatment of SLE, and do KOLs have any concerns about its use? Benlysta was the first targeted therapy approved for the treatment of SLE, but how does it fair against other treatments, including off-label Rituxan/MabThera (rituximab; Roche). Moreover, what concerns remain about the use of Benlysta, and how do KOLs believe these can be overcome?
Will a subcutaneous formulation of Benlysta drive growth? Since its launch in 2011, uptake of Benlysta has been slow, so will the availability of a subcutaneous formulation boost prescribing, or will efficacy and safety concerns remain?
The late-stage development pipeline comprises a number of targeted therapies, but which ones excite the most? Foremost amongst these is the anti-interferon-alpha mAb, anifrolumab. While early-stage data looked promising , do KOLs expect the Phase III studies to confirm these earlier findings, and how will this impact approval and launch? Moreover, how are other late-stage pipeline programmes shaping up, and which programmes are KOLs most excited about?
The mid-stage development pipeline is in rude health, but do KOLs expect any of these programmes to move into later-stage testing? A number of novel mAbs are in Phase II development, many of them possessing novel modes of action. But will they offer a welcome addition to the current treatment arsenal, or doe safety concerns, particularly with long-term use, remain?
Clinical attrition in the SLE pipeline remains an issue, but what do KOLs believe needs to be done to stop the rot? Study design is considered to be a significant contributing factor to failure rates, so what do KOLs believe needs to be done in relation to endpoint selection, comparator drug selection and study duration, and will these changes drive future R&D investment in SLE?
Will the development of biomarkers support selective use of the expanding array of targeted therapies? Given the expense of targeted therapies and the time taken to achieve clinical efficacy, will the use of biomarkers be crucial to ensuring their rational use? In the longer term, are biomarkers expected to emerge that will support diagnosis, monitoring, and prediction of future disease progression?
“If you look at the data, it [Benlysta] is not [that impressive]. With BLISS-76 there was no difference. I'm not sure I can actually say more than that, but there was no difference. So really it's quite weak data supporting that drug.”North American Key Opinion Leader
“Obviously this is awaited with great interest. We haven't seen the big Phase III trials yet. We need more information before we can make reasonable and sensible guesses, before we can really generate ideas as to whether or not this drug is going to be really good and exactly how it's going to be used.“EU Key Opinion Leader
Sample of therapies covered
Benlysta (belimumab; HGS/GSK)
Rituxan/MabThera (rituximab; Roche – OFF LABEL)
Voclosporin (Aurinia Pharma)
BIIB 059 (Biogen)
Dapirolizumab pegol (UCB)
Ustekinumab (Janssen Biotech)
Baricitinib (Eli Lilly)
Sample of KOLs interviewed
KOLs from North America
Mary Anne Dooley. Adjunct Professor of Medicine, University of North Carolina Kidney Center and Division of Nephrology & Hypertension, University of North Carolina, Chapel Hill School of Medicine.
Bevra H. Hahn. Chief, Rheumatology and Arthritis, and Professor and Vice Chair, School of Medicine, University of California, Los Angeles.Roberto Caricchio. Director and Associate Professor, Medicine, and Associate Professor, Microbiology and Immunology, Temple Lupus Clinic, Lewis Katz School of Medicine, Temple University, Philadelphia.
Petros Efthimiou. Associate Chief of Rheumatology, New York Presbyterian-Brooklyn Methodist Hospital, New York.Murray Urowitz. Director and Professor of Medicine, Centre for Prognosis Studies in the Rheumatic Diseases, Krembil Research Institute, University of Toronto, Canada
Victoria Werth. Professor of Dermatology and Medicine, University of Pennsylvania School of Medicine, Philadelphia.
KOLs from Europe
Venkat Reddy. MRCP, Senior Research Associate, University College London, Centre for Rheumatology, Bloomsbury Rheumatology Unit, Chelsea and Westminster NHS Trust, London, UK.
David Isenberg. Professor and Consultant, Department of Rheumatology, University College London Hospitals NHS Foundation Trust, London, UK.
Nathalie Costedoat-Chalumeau. Professor, AP-HP, Centre de Référence National Pour le Lupus Systémique et le syndrome des Antiphospholipides, Service de Médecine Interne, Hôpital Pitié-Salpêtrière, Paris, France.
Raphaèle Seror. Professor, Rheumatology Unit, Bicêtre University Hospital, Le Kremlin Bicetre, France.
Ricard Cervera. Senior Consultant Physician and Head at the Department of Autoimmune Diseases, Hospital Clínic, Barcelona, Head of the Research Team on Systemic Autoimmune Diseases at the Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, and Professor at the Department of Medicine, Universitat de Barcelona. Barcelona, Spain.
Ronald Van Vollenhoven. Professor of Rheumatology at the University of Amsterdam's Faculty of Medicine, Head of the Clinical Immunology and Rheumatology department at Amsterdam’s Academic Medical Center and Head of the Rheumatology department at the VU University Medical Center.
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