ECTRIMS eLearning

Experts' opinion on 2nd-line treatments failure criteria for patients with multiple sclerosis
Author(s): ,
J. De Sèze
Affiliations:
CHU de Strasbourg, Strasbourg
,
P. Vermersch
Affiliations:
Université de Lille, CHU Lille, LIRIC-INSERM U995, Lille
,
P. Clavelou
Affiliations:
CHU de Clermont-Ferrand, Clermont-Ferrand
,
F. Durand-Dubief
Affiliations:
Hospices Civils de Lyon, Lyon
,
E. Maillart
Affiliations:
Hôpital Pitié-Salpêtrière, Paris
,
C. Mekies
Affiliations:
Polyclinique du Parc, Toulouse; Clinique des Cèdres, Blagnac
,
T. Moreau
Affiliations:
CHU Dijon Bourgogne, Dijon
,
C. Papeix
Affiliations:
Hôpital Pitié-Salpêtrière, Paris
,
A. Tourbah
Affiliations:
CHU de Reims, Reims
P. Labauge
Affiliations:
CHU de Montpellier, Montpellier, France
ECTRIMS Learn. de Seze J. 10/10/18; 229139; EP1300
Jerome de Seze
Jerome de Seze
Contributions
Abstract

Abstract: EP1300

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Diagnosis and differential diagnosis

Introduction: Failure criteria for patients with multiple sclerosis (MS) under 1st-line treatment are well documented. However, the literature is poor regarding 2nd-line treatments failure criteria.
Objectives: This work aimed at identifying convergences and differences in therapeutic attitudes among French MS experts, regarding 2nd-line treatments failure criteria.
Methods: A 2-phase approach was set out. Experts in 5 regional boards worked on identifying 2nd-line treatments failure criteria. These results were then collected and discussed by a national board of 11 experts.
Results: Patient evaluation is based on the Expanded Disability Status Scale (EDSS) test, at least once a year, and MRI. Brain and spinal rebaseline MRI must be performed at 6 months, then brain MRI once a year, without considering structures atrophy.
Bad prognosis criteria are age (>40 years old), high baseline EDSS, ethnicity and comorbidities.
Disease progression must be confirmed at 6 months because of frequent fluctuations under 2nd-line treatments and pseudo-relapses. Any confirmed disease progression is considered a therapeutic failure. Therapeutic failure is also based on clinical relapses and MRI activity.
Any change of 2nd-line treatment must be discussed in multidisciplinary meeting, not before 1 year of treatment, except in case of tolerance issues. Failure criteria are no longer valid after 3 years of treatment.
To avoid disability evolution, more stringency is necessary with 2nd-line treatments, despite the risk of therapeutic exhaustion.
Experts also highlighted differences in progression evaluations. Annual Symbol Digit Modalities Test (SMDT), 9 Hole Peg Test (9-HPT), Time 25 Foot Walk (T25-FW), decreasing walking distance despite unchanged EDSS, or low contrast visual acuity, could be considered as markers of treatment failure.
Other differences concern the reliability of a single MRI activity, depending on its location, or of a single relapse, whether it is a sensitive or a motor one, to change or not 2nd-line treatments.
Conclusions: Experts identified convergences and differences in therapeutic attitudes regarding 2nd-line treatments failure criteria.
They agree that disease progression must be considered along with EDSS, after 1 year of treatment.
As for differences, they are justified in the absence of published data.
These proposals should be evaluated in real life prospective cohorts.
Disclosure: J. De Sèze has received honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche and Medday. Research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Medday.
P. Vermersch has received honoraria and consulting fees from Biogen, Sanofi-Genzyme, Novartis, Teva, Merck, Roche, Servier, Celgene, Medday and Almirall. Research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Merck.
P. Clavelou has received honoraria and consulting fees from Almirall, MedDay, Merck, Novartis, Roche, Sanofi Genzyme and Teva, and research support from Biogen, Merck and Novartis.
F. Durand-Dubief served on the scientific advisory board for Merck Serono and Roche and received travel funding and/or speaker honoraria from Biogen, Merck Serono, Sanofi-Aventis, Genzyme, Novartis Pharma, Roche, and Teva.
E. Maillart has received consulting and lecturing fees, travel grants, from Biogen, Idec, Genzyme, Novartis, Merck Serono, Roche, Sanofi, and Teva Pharma, and research support from Novartis and Roche.
C. Mekies has received consulting and lecturing fees, advisory boards: Novartis, Biogen, Bayer, Merck, Teva, Sanofi-Genzyme, Allergan, Almirall, EISAI, Coloplast, Lundbeck, and Pfizer.
T. Moreau has received consulting fees and travels from TEVA, Roche, Biogen, Sanofi Genzyme, Merck Serono, Medday, Novartis.
C. Papeix has received compensation as a consultant, advisory board member or speaker for Roche, Novartis, Biogen, Teva-Aventis, Sanofi-Genzyme, Bayer Schering, Merck Serono and MedDay.
A. Tourbah has received consulting and lecturing fees, travel grants and research support from MedDay, Biogen Idec, Sanofi Genzyme, Novartis, Merck Serono, Teva Pharma and Roche.
P. Labauge has received honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche and Medday. Research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Medday.

Abstract: EP1300

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Diagnosis and differential diagnosis

Introduction: Failure criteria for patients with multiple sclerosis (MS) under 1st-line treatment are well documented. However, the literature is poor regarding 2nd-line treatments failure criteria.
Objectives: This work aimed at identifying convergences and differences in therapeutic attitudes among French MS experts, regarding 2nd-line treatments failure criteria.
Methods: A 2-phase approach was set out. Experts in 5 regional boards worked on identifying 2nd-line treatments failure criteria. These results were then collected and discussed by a national board of 11 experts.
Results: Patient evaluation is based on the Expanded Disability Status Scale (EDSS) test, at least once a year, and MRI. Brain and spinal rebaseline MRI must be performed at 6 months, then brain MRI once a year, without considering structures atrophy.
Bad prognosis criteria are age (>40 years old), high baseline EDSS, ethnicity and comorbidities.
Disease progression must be confirmed at 6 months because of frequent fluctuations under 2nd-line treatments and pseudo-relapses. Any confirmed disease progression is considered a therapeutic failure. Therapeutic failure is also based on clinical relapses and MRI activity.
Any change of 2nd-line treatment must be discussed in multidisciplinary meeting, not before 1 year of treatment, except in case of tolerance issues. Failure criteria are no longer valid after 3 years of treatment.
To avoid disability evolution, more stringency is necessary with 2nd-line treatments, despite the risk of therapeutic exhaustion.
Experts also highlighted differences in progression evaluations. Annual Symbol Digit Modalities Test (SMDT), 9 Hole Peg Test (9-HPT), Time 25 Foot Walk (T25-FW), decreasing walking distance despite unchanged EDSS, or low contrast visual acuity, could be considered as markers of treatment failure.
Other differences concern the reliability of a single MRI activity, depending on its location, or of a single relapse, whether it is a sensitive or a motor one, to change or not 2nd-line treatments.
Conclusions: Experts identified convergences and differences in therapeutic attitudes regarding 2nd-line treatments failure criteria.
They agree that disease progression must be considered along with EDSS, after 1 year of treatment.
As for differences, they are justified in the absence of published data.
These proposals should be evaluated in real life prospective cohorts.
Disclosure: J. De Sèze has received honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche and Medday. Research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Medday.
P. Vermersch has received honoraria and consulting fees from Biogen, Sanofi-Genzyme, Novartis, Teva, Merck, Roche, Servier, Celgene, Medday and Almirall. Research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Merck.
P. Clavelou has received honoraria and consulting fees from Almirall, MedDay, Merck, Novartis, Roche, Sanofi Genzyme and Teva, and research support from Biogen, Merck and Novartis.
F. Durand-Dubief served on the scientific advisory board for Merck Serono and Roche and received travel funding and/or speaker honoraria from Biogen, Merck Serono, Sanofi-Aventis, Genzyme, Novartis Pharma, Roche, and Teva.
E. Maillart has received consulting and lecturing fees, travel grants, from Biogen, Idec, Genzyme, Novartis, Merck Serono, Roche, Sanofi, and Teva Pharma, and research support from Novartis and Roche.
C. Mekies has received consulting and lecturing fees, advisory boards: Novartis, Biogen, Bayer, Merck, Teva, Sanofi-Genzyme, Allergan, Almirall, EISAI, Coloplast, Lundbeck, and Pfizer.
T. Moreau has received consulting fees and travels from TEVA, Roche, Biogen, Sanofi Genzyme, Merck Serono, Medday, Novartis.
C. Papeix has received compensation as a consultant, advisory board member or speaker for Roche, Novartis, Biogen, Teva-Aventis, Sanofi-Genzyme, Bayer Schering, Merck Serono and MedDay.
A. Tourbah has received consulting and lecturing fees, travel grants and research support from MedDay, Biogen Idec, Sanofi Genzyme, Novartis, Merck Serono, Teva Pharma and Roche.
P. Labauge has received honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche and Medday. Research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Medday.

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