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Abstract Details

A multicentre, open label, single-arm, phase 3b study (CONSONANCE) to assess the effectiveness and safety of ocrelizumab in patients with primary and secondary progressive multiple sclerosis: year-1 interim analysis
Multiple Sclerosis
P1 - Poster Session 1 (9:00 AM-5:00 PM)
290
To report year-1 interim analysis results of the single-arm, phase 3b CONSONANCE study (NCT03523858) designed to evaluate effectiveness and safety of ocrelizumab in patients with primary (PPMS) or secondary progressive multiple sclerosis (SPMS).
Few treatment options are available for patients with progressive MS, with ocrelizumab being the only approved treatment for PPMS. CONSONANCE is the first trial to explore the effect of ocrelizumab in both forms of progressive MS.
Eligible patients receive ocrelizumab 600 mg every 24 weeks for up to 4 years. Primary endpoints include (1) No Evidence of Progression (NEP) defined as absence of 24-week confirmed clinical progression (as measured by increase in EDSS score; ≥20% increase in 25-foot walk test [25FWT]; ≥20% increase in nine-hole peg test [9HPT]) and (2) No Evidence of Progression or Active Disease (NEPAD) defined as NEP plus absence of protocol-defined relapses, new/enlarging T2 lesions (N/E-T2) or T1 gadolinium-enhancing lesions. 
The analysis included 629 (SPMS 325; PPMS 304) patients (mean age 48.5 years, 52.3% female). At baseline, median (interquartile-range) EDSS score was 5.5 (4.0–6.0), and times for 9HPT and 25FWT were 32.6 (15.7) and 14.9 (17.0) seconds, respectively. During year 1, 457/610 (74.9%) patients showed NEP (SPMS 78.2%; PPMS 71.3%) and 361/615 (58.7%) had NEPAD (SPMS 58.9%; PPMS 58.4%). Progression was mostly driven by 25FWT (16.1%), and activity by N/E-T2 (19.3%, detected almost exclusively in the first 6 months). In total, 473/629 (75.2%) patients had ≥1 adverse event (AE), and 42/629 (6.7%) experienced ≥1 serious AE. One death was reported.

Effectiveness and safety were similar for patients with SPMS and PPMS and outcomes were consistent with results from the phase 3 trial ORATORIO, suggesting treatment with ocrelizumab over 1 year is associated with low levels of disease progression and activity in both forms of progressive MS. Longer-term treatment in CONSONANCE is ongoing. 
Authors/Disclosures
Giancarlo Comi, MD (University Vita-Salute)
PRESENTER 		Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aspen Healthcare. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sanofi. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Rewind.
Robert A. Bermel, MD, FAAN (Cleveland Clinic) Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/Roche. Dr. Bermel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Bermel has received research support from Biogen. The institution of Dr. Bermel has received research support from Roche. The institution of Dr. Bermel has received research support from Novartis. Dr. Bermel has received intellectual property interests from a discovery or technology relating to health care.
Amit Bar-Or, MD, FRCPC (University of Pennsylvania) Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for cabaletta. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/EMD Serono. Dr. Bar-Or 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. Bar-Or has received research support from Novartis. The institution of Dr. Bar-Or has received research support from Biogen. The institution of Dr. Bar-Or has received research support from Roche/Genentech.
Marisa P. McGinley, DO (Cleveland Clinic) Dr. McGinley has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. McGinley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. The institution of Dr. McGinley has received research support from Biogen. The institution of Dr. McGinley has received research support from Genentech. The institution of Dr. McGinley has received research support from NIH. The institution of Dr. McGinley has received research support from AHRQ. The institution of Dr. McGinley has received research support from EMD Serono.
Douglas L. Arnold, MD, FAAN (Montreal Neurological Institute, McGill Univ) Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Find therapeutics. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kiniksa. Dr. Arnold has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Clario.
Roland G. Henry, PhD (University of California, San Francisco) Dr. Henry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MEDDAY. Dr. Henry 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. Henry has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Henry has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi/Genzyme.
Ralph H. Benedict, PhD (University At Buffalo) Dr. Benedict has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Benedict has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Benedict has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Meyers Squibb. Dr. Benedict has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic Therapeutics. Dr. Benedict has received intellectual property interests from a discovery or technology relating to health care.
Pavan Bhargava, MD, FAAN (Johns Hopkins University) The institution of Dr. Bhargava has received research support from EMD Serono. The institution of Dr. Bhargava has received research support from Amylyx pharmaceuticals. The institution of Dr. Bhargava has received research support from Genentech. The institution of Dr. Bhargava has received research support from GSK.
Helmut Butzkueven, MD, MBBS Dr. Butzkueven has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Oxford Health Policy Forum. The institution of Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. The institution of Dr. Butzkueven has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. The institution of Dr. Butzkueven has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for MSBase . The institution of Dr. Butzkueven has received research support from NHMRC. The institution of Dr. Butzkueven has received research support from Biogen. The institution of Dr. Butzkueven has received research support from Roche. The institution of Dr. Butzkueven has received research support from Novartis.
Declan Chard (UCL Queen Square Institute of Neurology) Declan Chard has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Declan Chard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffmann-La Roche. Declan Chard has received research support from MS Society. Declan Chard has received research support from Hoffmann-La Roche. Declan Chard has received research support from International Progressive MS Alliance. Declan Chard has received personal compensation in the range of $500-$4,999 for serving as a speaker with Novartis. Declan Chard has a non-compensated relationship as a trustee with MS Trust that is relevant to AAN interests or activities. Declan Chard has a non-compensated relationship as a editorial board member with Neurology that is relevant to AAN interests or activities. Declan Chard has a non-compensated relationship as a co-supervisor of a clinical fellowship at the National Hospital for Neurology and Neurosurgery, London, with Merck that is relevant to AAN interests or activities.
No disclosure on file
No disclosure on file
No disclosure on file
Letizia M. Leocani, MD (University Vita-Salute San Raffaele, INSPE) Dr. Leocani has received personal compensation in the range of $0-$499 for serving as a Consultant for Roche . Dr. Leocani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Leocani 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. Dr. Leocani has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Med-ex learning.
No disclosure on file
Thomas Kuenzel No disclosure on file
Xavier Montalban, MD, PhD, FAAN (Vall Hebron University Hospital-Multiple Sclerosis Centre of Catalonia) The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck/ EMD Serono. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Hoffmann-La Roche. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion/ Janssen Pharmaceuticals. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BMS/ Celgene. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/ Genzyme. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BIAL PD. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PeerVoice. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung Biosys. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas BioPharma. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion/ Janssen Pharmaceuticals. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS/ Celgene. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/ EMD Serono. Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffmann-La Roche. Dr. Montalban 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-Genzyme. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic Therapeutics. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viatris/ Mylan. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. The institution of Dr. Montalban has received research support from Biogen. The institution of Dr. Montalban has received research support from Hoffmann-La Roche. The institution of Dr. Montalban has received research support from Sanofi/ Genzyme. The institution of Dr. Montalban has received research support from Merck/ EMD Serono. The institution of Dr. Montalban has received research support from Novartis. The institution of Dr. Montalban has received research support from Teva Pharmaceuticals. The institution of Dr. Montalban has received research support from Actelion/ Janssen Pharmaceuticals. The institution of Dr. Montalban has received research support from BMS/ Celgene.
Maria Pia Sormani (University of Genoa) Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol meyer. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunic. Maria Pia Sormani 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, Roche. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche.
Finn Sellebjerg, MD (Copenhagen University Hospital Rigshospitalet) Dr. Sellebjerg has received personal compensation for serving as an employee of Danish Multiple Sclerosis Society. Dr. Sellebjerg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Sellebjerg has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Sellebjerg 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. Sellebjerg has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Sellebjerg 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 Genzyme. Dr. Sellebjerg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Sellebjerg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Sellebjerg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Sellebjerg has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Gangsted Foundation. Dr. Sellebjerg has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Warwara Larsen Foundation. The institution of Dr. Sellebjerg has received research support from Biogen. The institution of Dr. Sellebjerg has received research support from Merck. The institution of Dr. Sellebjerg has received research support from Novartis. The institution of Dr. Sellebjerg has received research support from Sanofi Genzyme. Dr. Sellebjerg has received publishing royalties from a publication relating to health care.
Licinio M. Craveiro, MD, PhD (Roche) Dr. Craveiro has received personal compensation for serving as an employee of Hoffmann La-Roche. Dr. Craveiro has received stock or an ownership interest from Hoffmann La-Roche.
Catherine Lubetzki (Hopital De La Salpetriere) Catherine Lubetzki has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ROCHE. Catherine Lubetzki has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MERCK SERONO. Catherine Lubetzki has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for REWIND.