International Conference on Multiple Sclerosis Comorbidities

26-28 March 2015

The Park Hyatt Hotel Toronto, Ontario

Canada

Hart House, University of Toronto, site of off-site dinner, 27 March

Conference Organized Under the Auspices of the

International Advisory Committee on Clinical Trials in MS

Conference and Committee Support/Funding: The National Multiple Sclerosis Society (US)

The European Committee on Treatment and Research in Multiple Sclerosis

Conference Chairs:

Ruth Ann Marrie, MD PhD Departments of Internal Medicine and Community Health Sciences

University of Manitoba Health Sciences Center Winnipeg, MN Canada

&

Jeffrey A. Cohen, MD The Mellen Center for MS Treatment & Research

Cleveland Clinic Cleveland, OH US

Conference Goals and Anticipated Outcomes

During the course of our Conference, we will review approaches to the study of comorbidity in MS and other chronic diseases. We will review work done to date on administrative and clinical datasets that may support MS comorbidity studies and aim to agree on those which are most useful; aim to develop consensus about the most relevant and important MS comorbidities in terms of incidence and prevalence, impact on outcomes and clinical trial design and analysis; strive to develop consensus about a common analysis protocol for comorbidity data and finally discuss and debate how to best integrate MS comorbidities into MS natural history studies and clinical trials. The Conference follows on a major research effort undertaken at the University of Manitoba under the direction of Dr Ruth Ann Marrie, which has created a current inventory of administrative and clinical datasets that include MS-relevant comorbid disease and behavior data worldwide and has created candidate lists of the most relevant MS comorbidities, and which has set the background for steps to create a common protocol for analysis across datasets and geographic health-related jurisdictions.

Meeting Program

Date/Time Topic Speaker Location/Room Arrival Day 26 Mar 15

17:00

Arrivals throughout the day Group Dinner, Park Hyatt Hotel

Mezzanine Lounge

Day 1 27 Mar 15

7:30 BREAKFAST University East 8:30 Welcome and Introduction Jeffrey Cohen (US) Hazelton Room 8.40 Meeting logistics and orientation Stephen Reingold (US)

8:45 Comorbidity in MS: definitions & goals of meeting Ruth Ann Marrie (CA)

Session 1: Introduction; Comorbidity in diseases other than MS

Session Chairs: Lorene Nelson (US) Bernard Hemmer (DE)

9:00 Comorbidity in epilepsy Nathalie Jetté (CA) 9.30 Discussion

9:40 Comorbidity in inflammatory bowel disease: insights from administrative data Charles Bernstein (CA)

10.10 Discussion

Session 2: Comorbidities and their role in clinical trials and observational studies

Session Chairs: Myla Goldman (US) Tobias Derfuss (CH)

10:20 Distinguishing comorbidities from drug-related adverse events in MS clinical trials Gavin Giovannoni (UK)

10.50 Discussion 11.00 REFRESHMENT BREAK Hazelton Foyer

11.30 Comorbidity as a predictor of outcome in clinical trials

Bianca Weinstock-Guttman (US) Marcia Finlayson (CA) (15 minutes each)

Hazelton Room

12.00 Discussion

12.10 Considerations in assessing the impact of comorbidity on outcomes in observational studies

Ralph Horwitz (US)

12.40 Discussion 12.50 LUNCH University East

Session 3: Data Sources for Comorbidities Session Chairs: Sandra Vukusic (FR) Scott Montgomery (SE)

14.00 MS Comorbidities - Survey & Systematic Review Findings and Group Discussion Ruth Ann Marrie (CA) Hazelton Room

16.00 REFRESHMENT BREAK Hazelton Foyer

16.30 Data sources: Administrative (general review of strengths & limitations for studies of comorbidity)

Joel Culpepper (US) Hazelton Room

17.00 Discussion

17.10 Data sources: Clinical datasets & registries (general review of strengths & limitations for studies of comorbidity)

Melinda Magyari (DK)

17.40 Discussion

17.50 Data Sources: Review of findings from the dataset inventory (potentially useful datasets and their characteristics)

Ruth Ann Marrie (CA)

18.10 Discussion

19.30 Off site dinner: Music Room, Hart House, University of Toronto

Hart House University of

Toronto

Day 2 28 Mar 15

Topic Speaker Location/Room

7:30 BREAKFAST University East

8.30 Review and summary of day 1 presentations and discussions Jeffrey Cohen (US) Hazelton Room

Session 4: Design and Analytics; Break-out Groups

8.45 Design & analytic issues in multiple concurrent incidence/prevalence studies Gary Cutter (US)

9.15 Discussion

9.25 Introduction and charge to Break Out Groups

Ruth Ann Marrie & Jeffrey Cohen

9.30-12.30 Break-out groups

1: Planning future incidence/prevalence studies in multiple jurisdictions: which conditions, where, who, how? New data collections vs. secondary analyses or combination of both

Discussion Leaders: Emmanuelle Waubant (US) Alan Thompson (UK)

Hazelton Room

2: Observational studies of the impact of comorbidities on MS: which conditions, what outcomes, where, who and how?

Discussion Leaders: Paul O’Connor (CA) Maria Trojano (IT)

University Central

3: Comorbidities and clinical trials of disease modifying and symptomatic therapies; understanding the impact of comorbidities on outcomes. Preferred design? Which comorbidities? What feasibility and epidemiologic work needs to be done prior to incorporating comorbidities into trial design & evaluation considerations

Discussion Leaders: Aaron Miller (US) Maria Pia Sormani (IT)

University West

12.30 LUNCH University East

14.00 Presentations by break-out groups & group discussion (½ hour each group; ½ hour general discussion)

Leaders of each group Hazelton Room

16.00 Next steps Ruth Ann Marrie/Jeffrey Cohen

16.30 Closing Jeffrey Cohen

Additional Discussants Brenda Banwell, US Bruce Bebo, US Giancarlo Comi, IT Devin Conway, US Kirsten Fiest, CA Andrew Goodman, US

Ari Green, US Hans-Peter Hartung, DE Karen Lee, CA Catherine Lubetzki, FR Fred Lublin, US David Miller, UK

Xavier Montalban, ES Jiwon Oh, CA Daniel Pelletier, US Anja Thormann, DK Bernard Uitdehaag, NL Jerry Wolinsky, US

Day 2 – Breakout Group Assignments

GROUP 1

Hazelton Room GROUP 2

University Central Room Group 3

University West Room

Planning Future Incidence

& Prevalence Studies Observational Studies of

Comorbidity Impact Comorbidities and

Clinical Trials Co-leaders Waubant O'Connor Miller A. Thompson Trojano Sormani Floaters Marrie Marrie Marrie Cohen Cohen Cohen Reingold Reingold Reingold Participants Bebo Conway Banwell Bernstein Goldman Comi Culpepper Green Finlayson Cutter Hartung Giovannoni Derfuss Horwitz Lubetzki Fiest Miller D. Lublin Goodman Nelson Montalban Hemmer Oh Montgomery Jette Thormann Pelletier

Lee Uitdehaag Weinstock-Guttman Magyari Vukusic Wolinsky