Abstract Details

Title MRI Activity versus Relapses as Markers of Disease Activity in SPMS: Data from Adelphi Real-World MS Disease Specific Programme and The Phase 3 EXPAND Study

Topic Multiple Sclerosis

Presentation(s) S14 - MS Therapeutics (5:18 PM-5:30 PM)

Poster/Presentation
Number 010

Background SPMS is categorized as active (aSPMS) or non-active (naSPMS) based on evident disease activity.

Objective Evaluate the contribution of MRI activity/relapses in defining disease activity in SPMS patients by analyzing Adelphi MS DSP data; understand whether active and non-active SPMS are mutually exclusive groups from EXPAND data.

Design/Methods Adelphi MS DSP consisted of 37,318 MS patients (3580 SPMS patients). Patients were categorized into aSPMS (≥1 new lesion on the most recent MRI and/or ≥1 relapse in the last 12 months) and naSPMS groups. In EXPAND, disease activity was defined as presence of relapses in the 2 years prior to screening and with/without ≥1 Gd+ T1 lesion at baseline. Demographics, MRI, and relapse status were analyzed descriptively.

Results SPMS patients from Adelphi MS DSP were categorized as aSPMS (n=1889) and naSPMS (n=665). Disease activity (aSPMS) was defined based on MRI lesions (59.1%), relapse status (12.6%), and both MRI and relapse (28.3%). In the past 12 months, aSPMS (vs naSPMS) patients had a lower mean EDSS (4.6 vs 5.2), a higher proportion of patients undergoing MRI (87.7% vs 58.7%), and more MRIs/patient (1.24 vs 0.87). A greater proportion of naSPMS (vs aSPMS) patients were without treatment (45.1% vs 23.4%). In EXPAND, 52.6% of patients (n/N=866/1645) without relapse in the 2 years prior to screening and Gd+ T1 lesions at baseline were categorized under naSPMS; of these naSPMS patients who were on placebo, 52.7% experienced on-study relapse and/or MRI activity: MRI (41.8%), relapses (4.6%), and both MRI and relapse (9.2%).

Conclusions In these studies, MRI activity appears to be a more sensitive measure of disease activity versus relapses. Even after 2 years of no relapse/MRI activity at baseline, disease activity returned in >50% of previously ‘non-active’ patients on placebo in EXPAND. Further, reduced real-world MRI monitoring decreases the chance to detect/treat new disease activity in ‘naSPMS’ patients.

Authors/Disclosures
Gavin Giovannoni, MD (QMUL) PRESENTER	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 $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. 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 Japanese Tobacco. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aurinia Pharmaceuticals. 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 $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. 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. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Oxford Health Policy Forum. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Peervoice. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Bristows .
	No disclosure on file
	No disclosure on file
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	No disclosure on file
Eddie Jones, BA	Eddie Jones, BA has nothing to disclose.
	No disclosure on file
Vladimir Bezlyak (Novartis Pharma AG)	Vladimir Bezlyak has received personal compensation for serving as an employee of Novartis Pharma AG. Vladimir Bezlyak has received stock or an ownership interest from Novartis Pharma AG.
Daniela Piani Meier	Daniela Piani Meier has received personal compensation for serving as an employee of Novartis Pharma AG.
Virginia DeLasHeras	Virginia DeLasHeras has received personal compensation for serving as an employee of NOVARTIS.
	No disclosure on file