This edition presents key opinion leader (KOL) views on recent developments in the moderate to severe psoriasis treatment market. Topics covered include: Janssen Biotech announcing new data from two pivotal Phase III studies reporting the efficacy and safety of guselkumab (anti-IL23 monoclonal antibody [mAb]) in the treatment of adults with moderate to severe plaque psoriasis; Sun Pharmaceutical announcing new data from two pivotal Phase III clinical trials of tildrakizumab, an investigational anti-IL23/p19 mAb being evaluated for the treatment of moderate-to-severe plaque psoriasis; Eli Lilly announcing new data from the Phase III IXORA-S study; and Merck KGaA and Ablynx reporting positive early-stage results for ALX-0761, a trivalent, bi-specific nanobody that blocks both IL-17A and IL-17F.
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*Latest* Update 3: April 2017
Update 2: January 2017
Update 1: October 2016
Original Publication: July 2016
*Purchase of this report includes all updates*
This update tackles these key questions
- How impressed are KOLs by the efficacy data from the VOYAGE 2 and NAVIGATE studies for guselkumab, and what could this do to support approval and future uptake?
- Do KOLs have any concerns about the design of the VOYAGE 2 and NAVIGATE studies?
- What are the primary advantages of using guselkumab; efficacy, dosing or both?
- Where will guselkumab be used in the psoriasis treatment paradigm, or is it too early to tell?
- What could get in the way of guselkumab’s evolution as the gold-standard treatment for moderate to severe psoriasis?
- How did KOLs react to the data from the reSURFACE 1 and 2 studies for tildrakizumab, and will this data limit or drive uptake as a treatment for psoriasis?
- Do KOLs have any issues with the design of tildrakizumab’s clinical studies, including
- patient selection and dosing? If so, what could be the potential impact on future uptake?
- Will tildrakizumab’s lack of differentiation limit its uptake, or do KOLs welcome the addition of a ‘softer’ treatment option?
- Where in the treatment paradigm will tildrakizumab be used?
- Does positive data from the IXORA-S study add anything new to ixekizumab’s story, or does it simply cement its position in the treatment paradigm?
- What will be the key reason physicians prescribe ixekizumab over other treatment options: safety, efficacy, patient access or something else?
- Where in the treatment paradigm will ixekizumab be used?
- How did KOLs react to the early stage data for ALX-0761?
Gain new KOL insights on the latest events that have the potential to impact the treatment landscape of moderate to severe plaque psoriasis. Topics covered include expert opinions on: UCB and Dermira announcing positive results from its Phase III CIMPASI and CIMPACT programmes, which aims to evaluate the efficacy and safety of Cimzia (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis; Sandoz publishing the results from its Phase III EGALITY study in the British Journal of Dermatology, which compared the safety and efficacy of GP2015, a proposed etanercept biosimilar, to Enbrel (etanercept) in patients with moderate-to-severe plaque psoriasis; Janssen Biotech announcing a US and European regulatory submission for guselkumab (formerly CNTO-1959), a human anti-interleukin-23 (IL-23) monoclonal antibody (mAb) being developed as a potential treatment for moderate-to-severe plaque psoriasis.
Update 1: J&J present the Phase III (VOYAGE 1) data of guselkumab
Gain new KOL insights on the latest events happening in psoriasis: Johnson & Johnson present the Phase III (VOYAGE 1) data of guselkumab, the experimental IL-23 monoclonal antibody being co-developed with MorphoSys; SunPharma announces positive Phase III (reSURFACE 1 and 2) data for its investigational IL-23p19 inhibitor, tildrakizumab; Can-Fite submitted Phase III clinical trial protocol for piclidenoson (CF101) to the EMA in the first half of 2016. The first-in-class orally bioavailable, adenosine receptor agonist (A3AR) will be evaluated in Phase II/III clinical studies against Otezla.
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Original Publication: Will innovative drugs or biosimilars dominate in psoriasis?
The emergence of biosimilar anti-TNFs could expand access to established biological therapies for psoriasis. However, recently launched therapies and pipeline agents can deliver better outcomes, for longer. Which options are most likely to gain ground in this increasingly crowded treatment landscape?
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Covering 9 currently marketed drugs, and 10 currently in clinical trials, the report reveals candid insights about the psoriasis landscape from 12 key opinion leaders (KOLs) in North America and Europe. You’ll learn which treatments satisfy dermatologists’ objectives for psoriasis treatment, whether oral therapies are overtaking injectables, and which pipeline drugs—both biosimilar and innovative molecules—are likely to succeed.
“The big issue is, if there are going to be three IL23s out in the next three years and they all get approved, we [already] have three IL17s, how are we going to make that choice between those six drugs?” - US KOL
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- Humira (adalimumab, Abbvie)
- Enbrel (etanercept, Amgen)
- Benepali (etanercept biosimilar, Biogen)
- Flixabi (infliximab biosimilar, Biogen)
- Otezla (apremilast, Celgene)
- Remsima/Inflectra (infliximab biosimilar, Celltrion/Pfizer)
- Taltz (ixekizumab, Eli Lilly)
- Remicade (infliximab, Merck & Co./Janssen)
- Cosentyx (secukinumab, Novartis)
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- Cosentyx (secukinumab, Novartis)
- Brodalumab (Amgen/AstraZeneca/Leo Pharma)
- Risankizumab (BI 655066, Boehringer Ingelheim/AbbVie)
- Piclidenoson (CF101, Can-Fite Biopharma)
- Guselkumab (anti-IL23, Janssen/Morphosys)
- Amiselimod (MT-1303, Mitsubishi Tanabe Pharma/Biogen)
- Xeljanz (tofacitinib, Pfizer)
- Etanercept biosimilar (GP2015. Sandoz [Novartis])
- Namilumab (MT-203, Takeda/Amgen)
- Cimzia (certolizumab pegol, UCB)
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Key Opinion Leaders Interviewed for This Report
North American KOLs
- Steven R. Feldman. Professor of Dermatology, Wake Forest University Health Sciences, NC.
- Joel Gelfand. Associate Professor, Department of Dermatology and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, PA.
- Neil Korman. Professor of Dermatology, Department of Dermatology, University Hospitals Case Medical Center, OH.
- Jeffrey Weinberg. Attending, Department of Dermatology, Mount Sinai St. Luke's Roosevelt, NY.
- Alan Menter. Chairman of the Division of Dermatology at Baylor University Medical Center, Waco, Texas.
- Stephen Tyring. Clinical Professor in the Departments of Dermatology, Microbiology/Molecular Genetics and Internal Medicine at the University of Texas Health Science Center, Houston, TX.
- Jashin J. Wu. Dermatologist, Kaiser Permanente, Los Angeles, CA.
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- Manuelle Viguier. Principal Clinical Investigator, Department of Dermatology, AP HP Hôpital Saint Louis, University Paris Diderot, Sorbonne Paris Cité, Paris, France.
- Carle Paul. Professor and Chairman of the Department of Dermatology at Paul Sabatier University, Toulouse, France.
- Antonio Costanzo. Full Professor of Dermatology, the Chairman of Dermatology and the Director of the Skin Pathology Laboratory, The Humanitas University, Milan, Italy.
- Robert Strohal. Department of Dermatology and Venerology, Federal University Teaching Hospital, Feldkirch, Austria.
- Mona Ståhle. Chair of the Dermatology and Venereology Unit, Department of Medicine, Karolinska Institute, Stockholm, Sweden.
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