Abstract Details

Title International Consensus on Smoldering Disease in Multiple Sclerosis using the Delphi Method

Topic Multiple Sclerosis

Presentation(s) P11 - Poster Session 11 (11:45 AM-12:45 PM)

Poster/Presentation
Number 3-013

Objective To develop consensus-driven statements on various domains of smoldering MS: definition, onset, underlying pathology, clinical and radiological manifestations, and modalities to detect smoldering disease in clinical practice. A deeper understanding of smoldering disease will optimize clinical management, foster drug discovery through identification of novel targets and help pwMS understand reasons for their decline.

Background Most people with multiple sclerosis (pwMS) experience neurological decline despite suppression of relapses or new lesions. Mounting evidence posits that multiple sclerosis (MS) is not only a disease of focal inflammation, but also involves more diffuse, smoldering pathological processes affecting the whole central nervous system (CNS). Smoldering MS contributes to clinical disease worsening although the underlying biology, clinical and radiological manifestations are yet to be adequately defined.

Design/Methods Fifteen MS experts from eight countries across Europe, US, and Canada convened to develop consensus-driven statements on smoldering MS across multiple domains. They employed the Delphi method to anonymously establish agreement on a 5-point scale with “consensus” defined a priori as >75% who agree or strongly agree.

Results

To date, consensus has been reached on statements related to the domain on definition. Examples are:

Smoldering disease is considered an umbrella term characterizing chronic pathobiological processes occurring in the CNS, beyond acute focal inflammation, associated with neurodegeneration leading to clinical worsening in pwMS, that may start early and continues throughout the disease course.
Progression independent of relapse activity (PIRA) should be considered primarily a clinical manifestation of smoldering disease and therefore those terms should not be used interchangeably

Conclusions This expert panel aims to provide further recommendations using the Delphi method to help educate the neurology community on smoldering disease and advise on its implementation into routine clinical practice. Full presentation and publication of all statements with supporting evidence is expected in 2023.

Authors/Disclosures
Francesca Bagnato, MD (Vanderbilt University Medical Center) PRESENTER	Dr. Bagnato has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Bagnato has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyne. Dr. Bagnato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Bagnato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jenseen. Dr. Bagnato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merk-Serono.
Antonio Scalfari, MD	Dr. Scalfari has nothing to disclose.
Jiwon Oh, MD, FAAN (St Michael's Hospital)	Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. The institution of Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen-Idec. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD-Serono. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Oh has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen-Idec. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. The institution of Dr. Oh has received research support from Biogen-Idec. The institution of Dr. Oh has received research support from Roche.
Laura Airas, MD, PhD (Turku University Hospital)	Dr. Airas has nothing to disclose.
Stefan Bittner	Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Biogen Idec. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Merck Healthcare. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Novartis. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Roche. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Sanofi. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Bristol-Meyer-Squibbs. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Teva.
Massimiliano Calabrese (The Multiple Sclerosis Center, University Hospital of Verona)	Massimiliano Calabrese has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis Pharma. Massimiliano Calabrese has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Serono. Massimiliano Calabrese has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Massimiliano Calabrese has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis Pharma. Massimiliano Calabrese has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Massimiliano Calabrese has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genzyme. Massimiliano Calabrese has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS Celgene. The institution of Massimiliano Calabrese has received research support from Roche.
Jose Manuel Garcia Dominguez (Hospital General Universitario Gregorio Marañón)	Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Almirall. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi Genzyme. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson & Johnson. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Almirall. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb.
Cristina Granziera, MD, PhD (Basel University Hospital)	The institution of Prof. Granziera has received research support from Novartis. The institution of Prof. Granziera has received research support from Hoffmann La Roche. The institution of Prof. Granziera has received research support from Genzyme Sanofi. The institution of Prof. Granziera has received research support from Biogen.
Benjamin M. Greenberg, MD, FAAN (UT Southwestern Medical Center)	Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Greenberg has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/Roche. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Signant. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IQVIA. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Greenberg has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Clene. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IQVIA. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abcuro. Dr. Greenberg has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Siegel Rare Neuroimmune Association. Dr. Greenberg has or had stock in GenrAb.Dr. Greenberg has or had stock in Clene.Dr. Greenberg has received intellectual property interests from a discovery or technology relating to health care. Dr. Greenberg has received publishing royalties from a publication relating to health care.
Kerstin Hellwig (St. Josef Hospital Bochum)	Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mylan . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche . The institution of Kerstin Hellwig has received research support from Roche . The institution of Kerstin Hellwig has received research support from Merck . The institution of Kerstin Hellwig has received research support from Biogen. The institution of Kerstin Hellwig has received research support from Genzyme . The institution of Kerstin Hellwig has received research support from Novartis . The institution of Kerstin Hellwig has received research support from BMS .
	No disclosure on file
Jan N. Lycke, MD	Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Lycke has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Lycke has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GeNeuro. The institution of Dr. Lycke has received research support from Sanofi.
Anthony Traboulsee, MD (University of British Columbia)	Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. The institution of Dr. Traboulsee has received research support from Roche. The institution of Dr. Traboulsee has received research support from Consortium of MS Centers. The institution of Dr. Traboulsee has received research support from MS Canada. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Workshop Chair with Consortium of MS Centers.
Veronica Popescu, MD, PhD (Rehabilitation & MS Centre)	The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme. The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Almirall. The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Almirall. The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Dr. Popescu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Dr. Popescu has received research support from FWO.
Gavin Giovannoni, MD (QMUL)	Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck KGaA. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche-Genentech. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Astoria Biologica. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape.

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