Contributions
Abstract: P883
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Teriflunomide (TFL, Aubagio®) 14 mg is a once‐daily oral disease‐modifying treatment (DMT) for relapsing‐remitting multiple sclerosis (RRMS). TFL has demonstrated consistent efficacy in two phase 3 studies in patients with RRMS and has a well-characterized safety profile. According to The Danish Medicines Council's treatment guideline, TFL is first choice DMT for adults with clinically isolated syndrome (CIS) and RRMS who have average disease activity. It is not recommended for women who wish to become pregnant within one year or for adults with highly active or rapidly evolving severe RRMS.
Objective: To describe treatment patterns, efficacy, safety/tolerability and adherence to TFL in a real world setting. Outcomes are patient characteristics at treatment initiation, lengths of the treatment episode, preceding and following treatments, time to discontinuation, and reason for discontinuation in an unselected population with MS.
Methods: Registry based observational cohort study including all cases enrolled following the standard clinical practice from November 2013 until the end of 2017. The data source is The Danish Multiple Sclerosis Registry which is a near complete nationwide population-based registry. Notification on all patients treated with DMT is mandatory and entered into the registry by the treating neurologist at treatment initiation and at the following scheduled visits which are 3 and 6 months after treatment start and then every 6 months.
Results: TFL treatment was initiated in 2562 patients with RRMS and CIS. Of these 1319 (52%) patients were treatment naïve. By the end of December 2017, 63% of the TFL-treated patients were still on TFL treatment. 391 (15%) of the patients underwent a lateral switch to DMT with similar efficacy. 345 (13,47%) underwent escalation therapy and 197 (7.7)% discontinued DMT for other reasons. Escalation therapy was initiated in 5.9% of patients within 1 year and in 11.9% of patients within 2 years. The average time to treatment escalation was 474 days.
Conclusion: This study provides timely and meaningful information on TFL treatment patterns and efficacy expressed in data are from the entire Danish MS population treated with TFL. Although observational studies are weaker methodologically than randomised trials, they have a number of distinct advantages, particularly in examining the frequency of events in real-life settings and not on selected sub-groups of patients.
Disclosure: Melinda Magyari has served on scientific advisory board for Biogen, Sanofi, Teva, Roche, Novartis, Merck, has received honoraria for lecturing and research support from Biogen, Merck, Novartis, Sanofi, Genzyme, has received support for congress participation from Biogen, Genzyme, Teva, Roche
Finn Sellebjerg has served on scientific advisory boards, been on the steering committees of clinical trials, served as a consultant, received support for congress participation, received speaker honoraria, or received research support for his laboratory from Biogen, EMD Serono, Merck, Novartis, Roche, Sanofi Genzyme and Teva
Zsolt Illes has no disclosures related to this study
Mathias Buron has nothing to disclose.
The Danish MS Registry received funding from Sanofi.
Abstract: P883
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Teriflunomide (TFL, Aubagio®) 14 mg is a once‐daily oral disease‐modifying treatment (DMT) for relapsing‐remitting multiple sclerosis (RRMS). TFL has demonstrated consistent efficacy in two phase 3 studies in patients with RRMS and has a well-characterized safety profile. According to The Danish Medicines Council's treatment guideline, TFL is first choice DMT for adults with clinically isolated syndrome (CIS) and RRMS who have average disease activity. It is not recommended for women who wish to become pregnant within one year or for adults with highly active or rapidly evolving severe RRMS.
Objective: To describe treatment patterns, efficacy, safety/tolerability and adherence to TFL in a real world setting. Outcomes are patient characteristics at treatment initiation, lengths of the treatment episode, preceding and following treatments, time to discontinuation, and reason for discontinuation in an unselected population with MS.
Methods: Registry based observational cohort study including all cases enrolled following the standard clinical practice from November 2013 until the end of 2017. The data source is The Danish Multiple Sclerosis Registry which is a near complete nationwide population-based registry. Notification on all patients treated with DMT is mandatory and entered into the registry by the treating neurologist at treatment initiation and at the following scheduled visits which are 3 and 6 months after treatment start and then every 6 months.
Results: TFL treatment was initiated in 2562 patients with RRMS and CIS. Of these 1319 (52%) patients were treatment naïve. By the end of December 2017, 63% of the TFL-treated patients were still on TFL treatment. 391 (15%) of the patients underwent a lateral switch to DMT with similar efficacy. 345 (13,47%) underwent escalation therapy and 197 (7.7)% discontinued DMT for other reasons. Escalation therapy was initiated in 5.9% of patients within 1 year and in 11.9% of patients within 2 years. The average time to treatment escalation was 474 days.
Conclusion: This study provides timely and meaningful information on TFL treatment patterns and efficacy expressed in data are from the entire Danish MS population treated with TFL. Although observational studies are weaker methodologically than randomised trials, they have a number of distinct advantages, particularly in examining the frequency of events in real-life settings and not on selected sub-groups of patients.
Disclosure: Melinda Magyari has served on scientific advisory board for Biogen, Sanofi, Teva, Roche, Novartis, Merck, has received honoraria for lecturing and research support from Biogen, Merck, Novartis, Sanofi, Genzyme, has received support for congress participation from Biogen, Genzyme, Teva, Roche
Finn Sellebjerg has served on scientific advisory boards, been on the steering committees of clinical trials, served as a consultant, received support for congress participation, received speaker honoraria, or received research support for his laboratory from Biogen, EMD Serono, Merck, Novartis, Roche, Sanofi Genzyme and Teva
Zsolt Illes has no disclosures related to this study
Mathias Buron has nothing to disclose.
The Danish MS Registry received funding from Sanofi.