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乾癬:KOL (キーオピニオンリーダー) による分析

Psoriasis: KOL Insight [2018]

発行 FirstWord 商品コード 372760
出版日 ページ情報 英文
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乾癬:KOL (キーオピニオンリーダー) による分析 Psoriasis: KOL Insight [2018]
出版日: 2018年10月30日 ページ情報: 英文
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概要

当レポートでは、乾癬の上市済み薬剤9種および開発段階の薬剤10種を取り上げ、北米および欧州の12名のキーオピニオンリーダー(KOL) による各種見解をまとめています。

上市済み薬剤

  • Humira (アダリムマブ:Abbvie)
  • Enbrel (エタネルセプト:Amgen)
  • Benepali (エタネルセプトバイオシミラー:Biogen)
  • Flixabi (インフリキシマブバイオシミラー:Biogen)
  • Otezla (アプレミラスト:Celgene)
  • Remsima/Inflectra (インフリキシマブバイオシミラー:Celltrion/Pfizer)
  • Taltz (イキセキズマブ:Eli Lilly)
  • Remicade (インフリキシマブ:Merck & Co./Janssen)
  • Cosentyx (セクキヌマブ:Novartis)

パイプライン薬剤

  • Cosentyx (セクキヌマブ:Novartis)
  • Brodalumab (Amgen/AstraZeneca/Leo Pharma)
  • Risankizumab (BI 655066:Boehringer Ingelheim/AbbVie)
  • Piclidenoson (CF101:Can-Fite Biopharma)
  • Guselkumab (抗IL-23:Janssen/Morphosys)
  • Amiselimod (MT-1303:田辺三菱製薬/Biogen)
  • Xeljanz (トファシチニブ:Pfizer)
  • エタネルセプト バイオシミラー (GP2015 Sandoz Novartis)
  • Amilumab (MT-203:武田薬品工業/Amgen)
  • Cimzia (セルトリズマブペゴル:UCB)

調査の例

  • 多くの治療薬があるにもかかわらずアンメットニーズは依然として存在
    • KOL:特に長期的な有効性と費用対効果を確認したいと考えている
    • 将来の治療において他に求められているものとは?
  • 経口治療薬の限定的な導入
    • KOLは経口治療薬に熱心だが、経口デリバリー以上のものを求めている
    • パイプライン薬に求められるものとは?
  • 受け入れられつつあるバイオシミラー
    • 好都合の償還上の決定が競合を激化させる可能性も
    • 実際の臨床現場での導入に影響する因子とは?
  • 複数のIL標的薬の違い
    • 現在の基準であるStelara (ustekinumab)の標的はIL-12/23
    • 新たな競合相手はIL-17・IL-23のみを標的に
    • KOLはこれらの次世代mAbsをどう考えるか?
  • 新しいパスウェイのさまざまなフィードバック
    • 初期候補薬はこれまで標的とされなかった新たなパスウェイを利用
    • KOLが期待するものとは?
  • 安全性:主要な懸念事項
    • 副作用と長期の安全性:新たな治療薬における懸念
    • その内容とKOLの考える利用への影響
  • 台頭する個別化医療
    • KOLは現在の治療薬による成果は改善するだろうと期待
    • 個別化医療の可能性についても楽観的
    • この動向が形成する将来の市場像とは?
目次

Will biosimilar anti-TNFs prevent novel therapies from gaining traction?

As the use of biosimilar anti-TNFs continues to expand access , and lower the costs of, biologic therapies in the treatment for psoriasis, is there room for novel products, such as the anti-interleukin-(IL)-17 mAbs and next-generation anti-IL23 mAbs? What about recently approved products, such as Siliq/Kyntheum (brodalumab), and Tremfya (guselkumab; Janssen/MorphoSys)? Clinical and commercial differentiation will become critical and as the treatment landscape becomes more crowded. Learn how KOLs see the market evolving, how current products can protect market share, and how developers can differentiate their pipeline therapies in KOL Insight: Psoriasis. Twelve North American and European KOLs provide their insight on 11 marketed products and over 15 pipeline programmes.

Take a tour of the report now:

  • Methodology >
  • Research Objectives >
  • Questions Asked >
  • See the RCC therapies covered >
  • Find out who the 6 US and 6 European KOLs are >
  • Sample Pages >

Top Takeaways

  • What does the future hold for branded anti-TNFs? Anti-TNFs have the most long-term safety and efficacy data to substantiate their clinical use, with Humira (adalimumab; AbbVie) being the 'go-to' drug in this category for many KOLs. But with several anti-TNF biosimilars scooping up market share, and more on the way, what does the future hold for branded anti-TNFs?
  • What impact will next-generation anti-IL23 mAbs have on the treatment landscape? KOLs are impressed with anti-IL12/23 mAbs, such as Stelara (ustekinumab; Janssen Biotech), but can newer drugs in this category, such as Tremfya (guselkumab; Janssen Biotech/MorphoSys), move things on even further? And will the lack of long-term real-world safety data hamper near-term commercial dynamics?
  • How do KOLs describe the anti-IL17 mAbs? Safe, effective, quick? What concerns remain, particularly for products with chequered development histories and the emergence of rare adverse effects such as IBD and Crohn's disease? KOLs predict a future tussle between the anti-IL17 mAbs, but with which class of product?
  • Will payers influence the uptake of pipeline psoriasis drugs? If so, will this be based purely on cost and benefit of biosimilars, or do KOLs expect payers to look more closely at the data and allow patients to gain access to more effective treatments?
  • What have KOLs asked for from future treatments for psoriasis? Would KOLs prefer drugs that demonstrate long-term safety and disease remission, ones that allow for dosage flexibility and personalisation of treatment, or ones that are effective on the skin as well as joints?
  • Does the psoriasis treatment landscape have a differentiation problem? With many treatments available, and more on the way, what are KOLs most concerned about? What could help physicians make better treatment decisions so that patient care is optimised?

Quotes

"Certainly there's no direct comparison, but on paper it [brodalumab] is more effective versus placebo than compared to secukinumab and ixekizumab. It genuinely does have a different mode of action, so there is a reason to use it after secukinumab or ixekizumab has failed because it almost gives you a bit more justification, you're not just using another IL17 blocker."

EU Key Opinion Leader

"The more you switch the risk of immunogenicity will increase. We have no concerns with Enbrel biosimilars, but Infliximab and adalimumab have immunogenic potential, and I would not like to risk the [loss of] response of the patient. I will have no problems to initiate a drug from the beginning."

US Key Opinion Leader

Sample of therapies covered

Marketed Therapies

  • Taltz (ixekizumab; Eli Lilly)
  • Benepali (etanercept; Biogen/Samsung Bioepis)
  • Remsima (infliximab; Celltrion/Napp/Mundipharma)
  • Inflectra (infliximab; Pfizer/Celltrion)
  • Cosentyx (secukinumab; Novartis)
  • Otezla (apremilast; Celgene)
  • Stelara (ustekinumab; Janssen Biotech)
  • Humira (adalimumab; AbbVie)
  • Remicade (infliximab; Janssen Biotech/Merck & Co.)
  • Enbrel (etanercept; Amgen/Pfizer)

Pipeline Therapies

  • Siliq/Kyntheum (brodalumab; Leo Pharma/AstraZeneca)
  • Tremfya (guselkumab; Janssen Biotech/MorphoSys)
  • Amgevita/Amjevita (adalimumab; Amgen)
  • Erelzi (etanercept; Sandoz)
  • BI 695501 (adalimumab; Boehringer Ingelheim)
  • Tildrakizumab (Merck & Co./Sun Pharma)
  • Xeljanz (tofacitinib; Pfizer)
  • Imraldi (adalimumab; Biogen/Samsung Bioepis)
  • Cimzia (certolizumab pegol; UCB)
  • Risankizumab (Boehringer Ingelheim/AbbVie)
  • Piclidenoson (Can Fite Biopharma)
  • Mirikizumab (Eli Lilly)
  • Namilumab (Takeda)
  • Bimekizumab (UCB)
  • Various adalimumab and etanercept biosimilars (e.g. M923, MSB11022)

KOLs from North America

  • Steven R. Feldman. Professor of Dermatology, Professor of Pathology, Professor of Public Health Sciences - Social Science and Health Policy, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.
  • Jeffrey M Weinberg. Associate Clinical Professor Dermatology, Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
  • Alan Menter. Dermatologist and Program Director, Dermatology Residency Program, Baylor University Medical Center, Baylor University, Dallas, Texas.
  • Robert T Brodell. Professor and Chair, Department of Dermatology, and Professor and Interim Chair of the Department of Pathology, University of Mississippi Medical Center, Jackson, Mississippi.
  • Bryan Cho. Dermatologist and Geneticist, Department of Dermatology, University of California, San Francisco.
  • Craig Leonardi. Associate Clinical Professor of dermatology at St. Louis University Medical School, St. Louis, Missouri.

KOLs from Europe

  • Puig Sanz. Director of the Department of Dermatology, Hospital de la Santa Creu i Sant Pau, an academic hospital which is affiliated with the Autonomous University of Barcelona.
  • Pablo Coto-Segura. Associate Professor of Dermatology, Hospital Universitario Central Asturias, Oviedo, Spain
  • Andrew Pink. Consultant Dermatologist, Guys and St. Thomas Hospital NHS Foundation Trust, London.
  • Richard Warren. Reader and Honorary Consultant Dermatologist, Division of Musculoskeletal & Dermatological Sciences, University of Manchester, UK
  • Odile Picard. Consultant at Saint Antoine Hospital in Paris, Professor of Dermatology at University of Saint-Antoine, France.
  • Anonymous German KOL. Professors and heads of a division with a specific focus on the treatment of inflammatory conditions, including psoriasis, at leading teaching hospitals in Germany.

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Table of Contents

1. Executive summary

2. Research objectives and focus

  • 2.1 Research objectives
  • 2.2 Research focus

3. Overview of current biologic therapies in psoriasis treatment

  • 3.1 Key insights summary
    • 3.1.1 Anti-TNFs
    • 3.1.2 Anti-IL12/IL23s
    • 3.1.3 Anti-IL17s

4. Branded anti-TNFs

  • 4.1 Humira (adalimumab; AbbVie)
    • 4.1.1 Key insights summary
    • 4.1.2 Drug summary
  • 4.2 Enbrel (etanercept; Amgen)
    • 4.2.1 Key insights summary
    • 4.2.2 Drug summary
  • 4.3 Remicade (infliximab; Merck & Co./Janssen Biotech)
    • 4.3.1 Key insights summary
    • 4.3.2 Drug summary

5. Anti-TNF biosimilars

  • 5.1 Flixabi (infliximab; Merck & Co./Samsung Bioepis)
  • 5.2 Benepali (etanercept; Samsung Bioepis/Biogen)
  • 5.3 Remsima/Inflectra (infliximab; Celltrion/Hospira)
  • 5.4 Amgevita/Amjevita (adalimumab; Amgen)
  • 5.5 Erelzi (etanercept; Sandoz)
  • 5.6 Position of biosimilar anti-TNFs in psoriasis treatment paradigm
    • 5.6.1 Key insights summary
  • 5.7 Impact of anti-TNF biosimilars on the psoriasis treatment paradigm
    • 5.7.1 Key insights summary

6. Anti-IL12/23s

  • 6.1 Stelara (ustekinumab; Janssen Biotech)
    • 6.1.1 Key insights summary
    • 6.1.2 Drug summary

7. Anti-IL17s

  • 7.1 Cosentyx (secukinumab; Novartis)
    • 7.1.1 Key insights summary
    • 7.1.2 Drug summary
  • 7.2 Taltz (ixekizumab; Eli Lilly)
    • 7.2.1 Key insights summary
    • 7.2.2 Drug summary

8. PDE-IV inhibitors

  • 8.1 Otezla (apremilast; Celgene)
    • 8.1.1 Key insights summary
    • 8.1.2 Drug summary

9. Selected late-stage pipeline programmes

  • 9.1 Certolizumab pegol (Cimzia; UCB)
    • 9.1.1 Key insights summary
    • 9.1.2 Drug summary
  • 9.2 Tremfya (guselkumab; Janssen Biotech/MorphoSys)
    • 9.2.1 Key insights summary
    • 9.2.2 Drug summary
  • 9.3 Tildrakizumab (MK3222; Sun Pharma/Merck & Co./Almirall)
    • 9.3.1 Key insights summary
    • 9.3.2 Drug summary
  • 9.4 Risankizumab (BI655066; Boehringer Ingelheim/AbbVie)
    • 9.4.1 Key insights summary
    • 9.4.2 Drug summary
  • 9.5 Brodalumab (Siliq/Kyntheum; Valeant/Leo Pharma/AstraZeneca)
    • 9.5.1 Key insights summary
    • 9.5.2 Drug summary

10. Early- to mid-stage pipeline programmes

  • 10.1 JAK inhibitors
    • 10.1.1 Tofacitinib (Xeljanz; Pfizer)
  • 10.2 Adenosine A3 receptor (A3AR) antagonists
    • 10.2.1 Piclidenoson (CF101; Can-Fite Biopharma)
  • 10.3 Granulocyte macrophage colony-stimulating factor neutralisation
    • 10.3.1 Namilumab (MT-203; Takeda/Amgen)

11. Future of the psoriasis treatment paradigm

  • 11.1 Key insights summary
    • 11.1.1 Future of anti-TNFs
    • 11.1.2 Future of anti-IL12/23s
    • 11.1.3 Future of anti-IL17s
    • 11.1.4 KOL views on combination therapy

12. Evolution of the psoriasis treatment landscape

  • 12.1 Key insights summary

13. Appendix

  • 13.1 KOL Biographies
    • 13.1.1 US KOLs
    • 13.1.2 European KOLs
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