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Rheumatoid Arthritis: KOL Insight

Product Code:
Publication Date:
March 2016

Latest Update

Gain new KOL insights on the latest events happening in rheumatoid arthritis (RA). During September 2016, the US FDA approved Amgen's Amjevita (adalimumab-atto), as a biosimilar to AbbVie's Humira for multiple inflammatory diseases, including RA. In September 2016, Gilead Sciences initiated a Phase II trial to evaluate the safety, tolerability, and efficacy of GS 9876, a Syk kinase inhibitor, in patients with active RA on background therapy with methotrexate. In October 2016, Sanofi and Regeneron announced that the US FDA issued a complete response letter regarding their application for the investigational IL-6R antibody, sarilumab.

*Latest* Update 3: Dec 2016
Update 2: October 2016
Update 1: June 2016
Original Publication: March 2016
*Purchase of this report includes all updates*

This update tackles these key questions

  • What are the reactions from KOLs regarding the FDA approval of the first Humira biosimilar, Amjevita?
  • In a biosimilar market that looks set to grow, which factors will influence their uptake and what are KOLs’ views on switching between biosimilars?
  • To what extent are KOLs concerned by “certain deficiencies” found at Sanofi’s Le Trait facility in which sarilumab is filled and finished?
  • How does sarilumab compare with Actemra/RoActemra and where in the treatment paradigm would such an agent be positioned?
  • How do KOLs react to the development of another Syk inhibitor, GS 9876?
  • Where in the treatment paradigm do KOLs expect GS 9876 to be used and which other MOAs will be of interest going forward

Update 2

Gain new KOL insights on the latest events happening in rheumatoid arthritis (RA): Topics covered include reactions to the Phase III SIRROUND-D trial, evaluating Janssen/GlaxoSmithKline’s human anti-interleukin (IL)-6 monoclonal antibody, sirukumab; topline results from a second Phase IIb study on Ablynx’s anti-IL-6R nanobody, vobarilizumab; as well as the initiation of the global Phase III (FINCH) programme investigating the efficacy and safety of Galapagos’ Janus kinase 1 (JAK-1) inhibitor, filgotinib.

Update 1

Gain new KOL insights on the latest events happening in rheumatoid arthritis (RA) treatment landscape. Topics covered include reaction to the availability of a new biosimilar version of the anti-TNF, infliximab; Pfizer’s Xeljanz (tofacitinib) 5 mg tablets accepted for review by European Medicines Agency (EMA); as well as opinions on Can-Fite’s piclidenoson (CF 101).

Original Publication: Leading brands under threat as biosimilars and new pipeline drugs hit the market

Key opinion leaders (KOLs) say Rheumatoid Arthritis (RA) treatment is in for a shakeup thanks to anti-TNF biosimilars, new JAK inhibitors, and in the longer-term, other innovative pipeline drugs. Good news for doctors and patients, but what will it mean for the leading brands?

Find out in FirstWord’s KOL Insight: Rheumatoid Arthritis report. 

Covering 9 marketed RA drugs, and 7 pipeline drugs currently in clinical trials, this 98-page report gives you an in-depth look at how 12 KOLs in North America and Europe see the RA landscape.

You’ll get KOLs’ candid thoughts on how new drugs will affect the treatment paradigm, whether they’ll challenge established brands, and how doctors and payers will make key treatment and reimbursement decisions.

View: North American KOLs, EU KOLs, marketed drugs, pipeline drugs

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Answering key questions

Marketed Drugs

  • Humira (adalimumab; AbbVie): Do KOLs think Humira's new formulation is enough to protect it against biosimilar adalimumab?
  • Enbrel (etanercept; Amgen/Pfizer): How will recently approved etanercept biosimilar, Benepali affect Enbrel’s leading position in the European market?
  • Remicade (infliximab; Janssen Biotech/Merck & Co): How much of an effect has biosimilar infliximab had on Remicade in Europe?
  • Simponi (golimumab; Janssen Biotech/Merck & Co): What’s preventing greater uptake of Simponi in the US?
  • Cimzia (certolizumab pegol; UCB): How likely are biosimilar adalimumab and biosimilar etanercept to threaten Cimzia’s market share?
  • Actemra/RoActemra (tocilizumab; Roche): Are US doctors following Europe’s lead and changing the way they use Actemra/RoActemra? 
  • Orencia (abatacept; Bristol-Myers Squibb): Are pipeline drugs likely to affect Orencia’s position in the treatment paradigm?
  • Rituxan/MabThera (rituximab; Genentech, Biogen/Roche): What kind of uptake do KOLs expect biosimilar rituximab to have in RA treatment?
  • Xeljanz (tofacitinib; Pfizer): How do KOLs expect Xeljanz to fare against pipeline JAK inhibitor, baricitinib?

Pipeline Drugs

  • Benepali (Samsung Bioepis): Will Benepali impact branded anti-TNFs?
  • sarilumab (SAR 153191; REGN 88; Sanofi/Regeneron): How do KOLs see the SARIL-RA-MONARCH trial? 
  • sirukumab (CNTO 136; Janssen/GlaxoSmithKline): How will the factors dictating choice of IL6 inhibitors differ in North America and Europe?
  • secukinumab (AIN 457; Novartis): Do KOLs see anti-IL17 drugs like secukinumab as promising treatments for RA?
  • baricitinib (INCB 28050, LY 3009104; Incyte/Eli Lilly): How do KOLs view baricitinib’s safety profile compared to Xeljanz’s?
  • peficitinib (ASP 015K; Astellas): Peficitinib is an oral JAK3 inhibitor - how do KOLs view JAK3 inhibition?
  • ABT 494 (AbbVie): After seeing its Phase II trial results, are KOLs optimistic about ABT 494? 
  • GP2015 (Novartis): What do KOLs think about prescribing GP2015 for RA? 
  • mavrilimumab (CAM 3001; AstraZeneca/MedImmune): What do KOLs think about mavrilimumab’s novel mechanism of action?

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Top takeaways

  • Big changes ahead: Find out how the triple-threat of biosimilars, pipeline drugs, and shifts in the treatment paradigm is shaking up the formerly quiet RA market.
  • Biosimilars threaten branded anti-TNFs: KOLs predict that biosimilars—e.g., recently approved Benepali—will have a big impact on branded anti-TNFs. Are any of the major players safe?
  • Other biologics also affected: Maybe not by biosimilars, but pipeline drugs are likely to challenge some mainstay biologics. Find out which ones are most at risk.
  • New JAK inhibitors threaten Xeljanz: Find out what KOLs think will dictate competition among JAK inhibitors, and whether Xeljanz can hold on to its first-to-market advantage.
  • Moving up or staying put: See which RA drugs are moving up the treatment paradigm, which aren’t, and how pipeline drugs are likely to affect them.
  • Pipeline drugs a mixed bag: KOLs are excited about some pipeline therapies, lukewarm about others, and in wait-and-see mode about the rest. How do they see your brand?
  • New MoAs showing promise: KOLs are optimistic about some pipeline drugs’ newer mechanisms of action. Discover which ones, and why.

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Key issues explored

  • Hunger for new treatments: The prospect of lower prices and better patient access has KOLs enthusiastic about biosimilars and pipeline drugs.  
  • Changing treatment paradigm: The RA treatment paradigm is already changing, and KOLs expect pipeline drugs to change it further in the next decade. Find out how.
  • Payer power: In the US, at least, payers have a big influence on prescription decisions. Learn how KOLs think that will affect new RA treatments.
  • Uptake will be different in US and Europe: Learn whether KOLs expect the US or European market to be more difficult for new drugs to penetrate.
  • Phase III trials eagerly anticipated: KOLs are cautiously optimistic about newer pipeline drugs but want Phase III data before drawing any conclusions.  Which trials are most important?
  • Interest in more selective treatments: Find out whether KOLs expect more selective JAK inhibitors to offer better safety and efficacy.
  • Using extrapolated data: Some biosimilars’ clinical data comes from studies in other disease areas. Are KOLs comfortable extrapolating that data to RA?

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A report based on expert knowledge

We interviewed 12 KOLs from North America and Europe between 02/12/2015 and 08/01/2016.

North American KOLs

  • Prof Michael E Weinblatt, MD. Professor of Medicine, Harvard Medical School; Co-director, Clinical Rheumatology, Brigham and Women's Hospital, Boston, MA, USA.
  • Dr Rohit Aggarwal, MD. Assistant Professor of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, USA.
  • Prof Eric L Matteson, MD. Professor of Medicine and Chair of the Department of Rheumatology, Mayo Clinic, Rochester, MN, USA.
  • Dr Petros Efthimiou, MD. Associate Chief of Rheumatology, New York Methodist Hospital; Associate Professor of Medicine and Rheumatology, Weill Cornell Medical College, New York, NY, USA.
  • Dr Yousaf Ali, MD. Associate Professor of Medicine, Division of Rheumatology, Mount Sinai Medical Center, New York, NY, USA.
  • Dr Michael H Weisman, MD. Director, Division of Rheumatology, Cedars-Sinai, West Hollywood, CA, USA.

European KOLs

  • Prof Ingrid Mӧller. Director and Consultant in Rheumatology and Musculoskeletal Sonography, Institut Poal of Rheumatology, Barcelona, Spain.
  • Anonymous. Professor of Internal Medicine and Rheumatology at a leading teaching hospital, Germany.
  • Anonymous. Professor at a leading university hospital, Germany.
  • Professor Arnaud Constantin. Consultant Physician, Rheumatologist, and university lecturer, University Hospital Toulouse; member of clinical research, Toulouse hospital, Toulouse, France.
  • Dr Jean David Cohen. Consultant Physician, Rheumatologist, University hospital Montpellier, Montpellier, France.
  • Dr Andrew Brown. Consultant Rheumatologist, York Teaching Hospital NHS Foundation Trust; Senior Lecturer, Medical Education and Rheumatology, Hull York Medical School, York, UK.

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