Author Of 2 Presentations
P0855 - Clinical Course and Therapeutic Management of SPMS in France: a retrospective real world multicentric observational study (ODYSSEP Study) (ID 1611)
Abstract
Background
There is little data on the description of Secondary Progressive Multiple Sclerosis (SPMS) in France, notably because there is a lack of therapeutic options to slow down the disease progression during that phase.
Objectives
Describe and understand Secondary Progressive Multiple Sclerosis (SPMS) clinical course and therapeutic management in France.
Methods
A retrospective multicentric observational study (ODYSSEP study) involving clinical longitudinal data was performed from the French prospective national cohort of MS patients (OFSEP). Inclusion criteria were diagnosis of SPMS and at least one clinical visit between 2013, January 1st and 2017, June15th. Sensitivity analysis, was also performed to include undiagnosed SPMS patients in OFSEP database using an automatized algorithm detecting patients with an increase in EDSS score without any activity (relapses and/or evidence of new MRI activity) between two clinical evaluations.
Results
3140 SPMS patients were included in the main analysis, and 454 additional patients were identified through the sensitivity analysis. Median age at onset of progression was 47 years, and 68% of the patients were women. Almost half of patients (48%) had at least one relapse during the follow-up; whereas only 10% had one during the last year of follow-up. Median EDSS at onset of progression was 4.5. During the follow-up of 9 years in mean, an increase of 1.6 points in EDSS score was observed. Treatments were described among the 908 patients with progression onset after 2013 specifically. At the time of SPMS diagnosis, 35.4% of patients were untreated, 30.6% and 26.3% were treated by first- and second-line disease modifying therapy (DMT)(mainly IFN: 13.4%), 6.4% by off-label treatments and 1.3% by biotin. During the SP phase, 63.6% of patients received at least one DMT; 30.6% were treated with first-line and 26.3% with second-line DMT. At the last clinical visit, 56.2% of patients were still treated, mainly by off-label treatments (26.5%); first-line and second-line DMT were less used (14.9% and 14.4%, respectively). Biotin was also frequently used (16.1%), either as the main treatment (10.6%) or associated with a DMT (5.5%).
Conclusions
These real world results from the French MS cohort indicate that most of SPMS patients are either untreated or taking off-label drugs. It reflects the current lack of satisfactory therapeutic options during the secondary progressive phase of MS and underlines the urgent need for new efficacious drugs specifically approved for SPMS.
P0876 - High and low efficacy therapy in secondary progressive multiple sclerosis after accounting for therapeutic lag. (ID 760)
Abstract
Background
In secondary progressive multiple sclerosis (SPMS), reduction in the rates of disability accrual after starting disease modifying therapy (DMT) has largely been limited to patients with ongoing inflammatory activity. A delayed treatment effect, termed therapeutic lag, may obscure therapeutic benefits in SPMS.
Objectives
To compare the effect of high and low efficacy DMT on disability outcomes in patients with recently active and inactive SPMS after accounting for therapeutic lag.
Methods
Using data from MSBase, a multinational MS registry, and OFSEP, the French MS registry, we identified patients with SPMS as per a previously validated objective definition. We identified patients treated with high- (natalizumab, alemtuzumab, mitoxantrone, ocrelizumab, rituximab, cladribine, fingolimod) or low-efficacy (interferons, glatiramer acetate, teriflunomide) DMT after SPMS onset. Based on our previous work, an individualised estimate of duration of therapeutic lag was calculated for each patient. Only events that occurred after the estimated therapeutic lag period were included in the analysis. Propensity score matching was used to select groups with comparable baseline characteristics. Disability and relapse outcomes were compared in paired, pairwise-censored analyses adjusted for visit density.
Results
Of 7359 patients with SPMS, 1000 patients fulfilled the criteria for study inclusion (510 active SPMS, 490 inactive SPMS). For the relapse outcomes, patients with active SPMS treated with high-efficacy DMTs experienced lower probabilities of relapses than low-efficacy DMTs (hazard ratio [HR] 0.7 [95%CI 0.5-0.9], p=0.006). Patients with inactive SPMS had similar probabilities of relapses in the high and low efficacy DMT groups (0.8 [0.6-1.2], p=0.39). No difference in the risk of 6-month sustained disability accumulation, or proportion of patients reaching EDSS>=7, was observed between groups when accounting for therapeutic lag.
Conclusions
The risk of disability accumulation in SPMS seems to be comparable in patients treated with high- and low- efficacy DMT. High efficacy DMT is superior to low efficacy therapy in reducing relapse activity in patients with active SPMS, but not those with inactive SPMS. Pre-treatment inflammatory activity, clinical or radiological, is a treatable target in SPMS which may benefit from higher-efficacy anti-inflammatory therapies.
Presenter Of 1 Presentation
P0855 - Clinical Course and Therapeutic Management of SPMS in France: a retrospective real world multicentric observational study (ODYSSEP Study) (ID 1611)
Abstract
Background
There is little data on the description of Secondary Progressive Multiple Sclerosis (SPMS) in France, notably because there is a lack of therapeutic options to slow down the disease progression during that phase.
Objectives
Describe and understand Secondary Progressive Multiple Sclerosis (SPMS) clinical course and therapeutic management in France.
Methods
A retrospective multicentric observational study (ODYSSEP study) involving clinical longitudinal data was performed from the French prospective national cohort of MS patients (OFSEP). Inclusion criteria were diagnosis of SPMS and at least one clinical visit between 2013, January 1st and 2017, June15th. Sensitivity analysis, was also performed to include undiagnosed SPMS patients in OFSEP database using an automatized algorithm detecting patients with an increase in EDSS score without any activity (relapses and/or evidence of new MRI activity) between two clinical evaluations.
Results
3140 SPMS patients were included in the main analysis, and 454 additional patients were identified through the sensitivity analysis. Median age at onset of progression was 47 years, and 68% of the patients were women. Almost half of patients (48%) had at least one relapse during the follow-up; whereas only 10% had one during the last year of follow-up. Median EDSS at onset of progression was 4.5. During the follow-up of 9 years in mean, an increase of 1.6 points in EDSS score was observed. Treatments were described among the 908 patients with progression onset after 2013 specifically. At the time of SPMS diagnosis, 35.4% of patients were untreated, 30.6% and 26.3% were treated by first- and second-line disease modifying therapy (DMT)(mainly IFN: 13.4%), 6.4% by off-label treatments and 1.3% by biotin. During the SP phase, 63.6% of patients received at least one DMT; 30.6% were treated with first-line and 26.3% with second-line DMT. At the last clinical visit, 56.2% of patients were still treated, mainly by off-label treatments (26.5%); first-line and second-line DMT were less used (14.9% and 14.4%, respectively). Biotin was also frequently used (16.1%), either as the main treatment (10.6%) or associated with a DMT (5.5%).
Conclusions
These real world results from the French MS cohort indicate that most of SPMS patients are either untreated or taking off-label drugs. It reflects the current lack of satisfactory therapeutic options during the secondary progressive phase of MS and underlines the urgent need for new efficacious drugs specifically approved for SPMS.