Personalised Medicine in MS

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1 Personalised Medicine in MS Supportive Evidence from Therapeutic Trials Ludwig Kappos Neurology and Department of Biomedicine University Hospital CH-4031 Basel

2 Established partially effective treatments and algorithms for the management of CIS and RR MS Pathogenesis: Better understanding of the complex interaction of immune system, genes and environmental factors - But no simple answers Development of new, more effective treatment options: Bench to Bedside and vice versa Learning about risks and balancing risks with benefits

3 Available and Aproaching (in the next 1-4 years) Treatment Options for Prevention of Relapses and Progression first line in relapsing disease IFNbeta 1b* (Betaferon ) 1 250µg 1x / 2d s.c. IFNbeta 1a* (Avonex ) (Rebif ) 1 1x / w 30µg i.m. 3 x 22 or 44µg/ W s.c. Glatiramer acetate* (Copaxone ) 20 mg/d s.c. Fingolimod** (Gilenya ) 0.5 mg/d oral BG-12** 2x 240 mg/d oral Teriflunomide* Aubagio (7 or) 14 mg/d oral Laquinimod* 0.6 mg/d oral Daclizumab (Dac-Hyp)** 150mg/4w s.c. second line or in aggressive disease Natalizumab*** (Tysabri ) 300mg i.v. 1x/ M Alemtuzumab*** (*) (Lemtrada ) Ocrelizumab*** Mitoxantrone** (*) (Novantron ) mg/m 2 / 4 w( 1-3x; then 1x / 3-6M ) 1 Also approved for treatment of SP MS; *Relapse reduction ~ 30%; ** ~50%; ***~70%; **** ~80-90%

4 Therapeutic options depend on MS Phase and disease course defining the window of opportunity Relapses and Impairment MRI Activity MRI T2 lesion load SP-MS RIS? CIS RR-MS Preclinical Disease Duration (Years)

5 Inflammation versus Neurodegeneration in MS Pathogenesis Inflammation: conduction block, demyelination, bystander axonal injury Degeneration Loss of axons / neurons Relapsing- Remitting Secondary Progressive Time since disease onset (30-40 years)

6 Clinical disability is a compound outcome

7 Criteria for personalised therapeutic choices in MS: Pathogenetic Target autoimmune attack / inflammation and/or degeneration Grade of Efficacy sustained / long term and/or induction therapy Risk /Convenience short term and/or long term AE

8 Current players pathogenetic targets: IFN beta autoimmune attack / inflammation / BBB Glatiramer autoimmune attack / inflammation / degeneration?? Natalizumab BBB /autoimmune attack / inflammation Fingolimod autoimmune attack / inflammation / degeneration? other

9 Emerging players pathogenetic targets: Oral compounds: Teriflunomide mild immunosuppression / immunomodulation - an oral alternative to IFNs and GAA? BG 12 (Dimethylfumarate) suppression of inflammation and neuroprotection (Nrf2 )? Laquinimod Neuroprotection versus suppression of inflammation?

10 Emerging players pathogenetic targets: Monoclonal antibodies: Alemtuzumab Pan-immune-cell depletion (early) rebooting of the immune system? Rituximab, Ocrelizumab, Ofetunumab B-cell depletion (but also Atacicept ) DAC-HYP (anti-il2-r), AIN457 (anti-il17) NK-Cells and Regulatory T- and B- Cells

11 Criteria for personalised therapeutic choices in MS: Pathogenetic Target autoimmune attack / inflammation and/or degeneration Grade of Efficacy early (induction therapy) and/or sustained / long term Risk /Convenience short term and/or long term AE

12 Current players grade of efficacy: IFN beta ARR %, Disability 30%?, MRI Infl ++, MRI Degen (+) Glatiramer ARR %, Disability 30%?, MRI Infl +, MRI Degen (+) Natalizumab ARR %, Disability 30-40%, MRI Infl +++, MRI Degen? Fingolimod ARR >50 %, Disability 30%, MRI Infl ++, MRI Degen +

13 Emerging players grade of efficacy: Oral compounds: Teriflunomide ARR %, Disability 30%, MRI Infl +(+), MRI Degen? BG 12 (Dimethylfumarate) ARR 50 %, Disability 30%, MRI Infl ++, MRI Degen (+) Laquinimod ARR 20 %, Disability 30%, MRI Infl +, MRI Degen +

14 Emerging players grade of efficacy: Monoclonal antibodies: Alemtuzumab (versus IFNB1a!) ARR 60 %, Disability 40%, MRI Infl ++,MRI Degen + DAC-HYP ARR %, Disability 30-40%, MRI Infl ++, MRI Degen? Ocrelizumab ARR 80 %, Disability?, MRI Infl ++,MRI Degen?

15 Criteria for personalised therapeutic choices in MS: Pathogenetic Target autoimmune attack / inflammation and/or degeneration Grade of Efficacy early (induction therapy) and/or sustained / long term Risk /Convenience short term and/or long term adverse events

16 Current players risks / convenience: IFN beta injection reactions, flu-like symptoms Glatiramer injection reactions Natalizumab PML (risk stratification) Fingolimod early bradycardic events, immunosuppression?..

17 Emerging players risks / convenience: Oral compounds: Teriflunomide hair loss, liver BG 12 (Dimethylfumarate) gastrointestinal AEs, flushing, liver Laquinimod

18 Emerging players risks / convenience: Monoclonal antibodies: Alemtuzumab Autoimmune events, immunosuppression, infusion reactions DAC-HYP Cutaneous events, hepatic reactions Ocrelizumab Immunosuppression,?

19 Additional information from Clinical Trials with impact on personalized therapeutic choices in MS: Better definition of responder / non responder populations by subgroup analysis Risk stratification

20 Subgroup analysis of Clinical Trials and its impact on personalized therapeutic choices in MS: The problems: smaller groups multiple testing how valid are (pre)baseline characteristics

21 Pars pro toto: Effects of Fingolimod on ARR across patient subgroups (FREEDOMS data) Age (years) 40 (n = 544) > 40 (n = 299) Previous treatment Untreated (n = 493) Treated (n = 350) High activity at baseline Yes (n = 140) No (n = 701) Number of Gd + T1 lesions at baseline 0 (n = 525) 1 (n = 315) Number of relapses in year before study 0 or 1 (n = 528) >1 (n = 315) Number of relapses in 2 years before study 1 (n = 256) 2 (n = 360) >2 (n = 226) Baseline EDSS (n = 709) >3.5 (n = 134) Baseline T2 lesions volume (mm 3 ) 3300 (n = 418) >3300 (n = 422) Favours fingolimod 0.5 mg Favours placebo Data are expressed as ARR ratios for fingolimod vs placebo with 95% confidence intervals. ITT population High activity at baseline was defined as 1 Gd + lesion and 2 relapses in the year before the study Devonshire et al, Lancet Neurology

22 Proportion With Sustained Progression Natalizumab: Efficacy in Patients with Highly Active Disease Patients With 2 Relapses in Prior Year and 1 Gd+ Lesion At Baseline Placebo Natalizumab Hazard ratio=0.36 P= Weeks Month Sustained Number of Patients at Risk Placebo 26% Natalizumab 10% % Annualized Relapse Rate Placebo n=61 P< % Natalizumab n=148 European Agency for the Evaluation of Medicinal Products. Natalzumab [summary of product characteristics];

23 Subgroup analysis of Clinical Trials and its impact on personalized therapeutic choices in MS: General trend for better response: younger age treatment naive more active (relapses, MRI) lower disability

24 Additional information from Clinical Trials with impact on personalized therapeutic choices in MS: Biomarkers Alemtuzumab and autoimmune events DAC HYP and change in CD56 bright cells

25 Summary Both, clinical trials and prospective observational (cohort) studies are needed for informed, personalised therapeutic decisions

26 MS-Team in Basel

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