Limits...
Comparative efficacy of switching to natalizumab in active multiple sclerosis.

Spelman T, Kalincik T, Zhang A, Pellegrini F, Wiendl H, Kappos L, Tsvetkova L, Belachew S, Hyde R, Verheul F, Grand-Maison F, Izquierdo G, Grammond P, Duquette P, Lugaresi A, Lechner-Scott J, Oreja-Guevara C, Hupperts R, Petersen T, Barnett M, Trojano M, Butzkueven H - Ann Clin Transl Neurol (2015)

Bottom Line: In the total population, switching to natalizumab reduced the risk of confirmed disability progression by 26% (P = 0.036) and decreased the total disability burden by 1.54 EDSS-years (P < 0.0001) over the first 24 months post switch.Using large, real-world, propensity-matched datasets we demonstrate that after a relapse on IFNβ or GA, switching to natalizumab (rather than between IFNβ and GA) led to superior outcomes for patients in all measures assessed.Results were consistent regardless of the prior treatment identity.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine and Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne Melbourne, Australia.

ABSTRACT

Objective: To compare treatment efficacy and persistence in patients who switched to natalizumab versus those who switched between glatiramer acetate (GA) and interferon-beta (IFNβ) after an on-treatment relapse on IFNβ or GA using propensity score matched real-world datasets.

Methods: Patients included were registered in MSBase or the TYSABRI Observational Program (TOP), had relapsed on IFNβ or GA within 12 months prior to switching to another therapy, and had initiated natalizumab or IFNβ/GA treatment ≤6 months after discontinuing prior therapy. Covariates were balanced across post switch treatment groups by propensity score matching at treatment initiation. Relapse, persistence, and disability measures were compared between matched treatment arms in the total population (n = 869/group) and in subgroups defined by prior treatment history (IFNβ only [n = 578/group], GA only [n = 165/group], or both IFNβ and GA [n = 176/group]).

Results: Compared to switching between IFNβ and GA, switching to natalizumab reduced annualized relapse rate in year one by 65-75%, the risk of first relapse by 53-82% (mean follow-up 1.7-2.2 years) and treatment discontinuation events by 48-65% (all P ≤ 0.001). In the total population, switching to natalizumab reduced the risk of confirmed disability progression by 26% (P = 0.036) and decreased the total disability burden by 1.54 EDSS-years (P < 0.0001) over the first 24 months post switch.

Interpretation: Using large, real-world, propensity-matched datasets we demonstrate that after a relapse on IFNβ or GA, switching to natalizumab (rather than between IFNβ and GA) led to superior outcomes for patients in all measures assessed. Results were consistent regardless of the prior treatment identity.

No MeSH data available.


Related in: MedlinePlus

Time to first relapse after treatment switch by prior treatment subgroup, (A) IFNβ, (B) GA, or (C) IFNβ and GA. *Reference group switched to BRACE. †Reference group switched to natalizumab. IFNβ, interferon-beta; GA, glatiramer acetate.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4402083&req=5

fig04: Time to first relapse after treatment switch by prior treatment subgroup, (A) IFNβ, (B) GA, or (C) IFNβ and GA. *Reference group switched to BRACE. †Reference group switched to natalizumab. IFNβ, interferon-beta; GA, glatiramer acetate.

Mentions: In all subgroups, on-treatment ARR in the first 12 months after switching treatment was lower in patients who switched to natalizumab compared to those who switched to another BRACE therapy; the relative reduction in ARR was 70% in subgroup 1, 65% in subgroup 2, and 75% in subgroup 3. ARR remained lower in the natalizumab group in subsequent years in all subgroups (Table3). Patients who switched to natalizumab also had a lower risk of first relapse and a lower risk of treatment discontinuation compared to patients who switched to another BRACE therapy in all subgroups. Figures4, 5 display the Kaplan–Meier curves of time to first relapse and treatment discontinuation for each prior treatment subgroup; relative risk reductions and rate increases associated with each treatment decision are included in the text on each figure.


Comparative efficacy of switching to natalizumab in active multiple sclerosis.

Spelman T, Kalincik T, Zhang A, Pellegrini F, Wiendl H, Kappos L, Tsvetkova L, Belachew S, Hyde R, Verheul F, Grand-Maison F, Izquierdo G, Grammond P, Duquette P, Lugaresi A, Lechner-Scott J, Oreja-Guevara C, Hupperts R, Petersen T, Barnett M, Trojano M, Butzkueven H - Ann Clin Transl Neurol (2015)

Time to first relapse after treatment switch by prior treatment subgroup, (A) IFNβ, (B) GA, or (C) IFNβ and GA. *Reference group switched to BRACE. †Reference group switched to natalizumab. IFNβ, interferon-beta; GA, glatiramer acetate.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4402083&req=5

fig04: Time to first relapse after treatment switch by prior treatment subgroup, (A) IFNβ, (B) GA, or (C) IFNβ and GA. *Reference group switched to BRACE. †Reference group switched to natalizumab. IFNβ, interferon-beta; GA, glatiramer acetate.
Mentions: In all subgroups, on-treatment ARR in the first 12 months after switching treatment was lower in patients who switched to natalizumab compared to those who switched to another BRACE therapy; the relative reduction in ARR was 70% in subgroup 1, 65% in subgroup 2, and 75% in subgroup 3. ARR remained lower in the natalizumab group in subsequent years in all subgroups (Table3). Patients who switched to natalizumab also had a lower risk of first relapse and a lower risk of treatment discontinuation compared to patients who switched to another BRACE therapy in all subgroups. Figures4, 5 display the Kaplan–Meier curves of time to first relapse and treatment discontinuation for each prior treatment subgroup; relative risk reductions and rate increases associated with each treatment decision are included in the text on each figure.

Bottom Line: In the total population, switching to natalizumab reduced the risk of confirmed disability progression by 26% (P = 0.036) and decreased the total disability burden by 1.54 EDSS-years (P < 0.0001) over the first 24 months post switch.Using large, real-world, propensity-matched datasets we demonstrate that after a relapse on IFNβ or GA, switching to natalizumab (rather than between IFNβ and GA) led to superior outcomes for patients in all measures assessed.Results were consistent regardless of the prior treatment identity.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine and Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne Melbourne, Australia.

ABSTRACT

Objective: To compare treatment efficacy and persistence in patients who switched to natalizumab versus those who switched between glatiramer acetate (GA) and interferon-beta (IFNβ) after an on-treatment relapse on IFNβ or GA using propensity score matched real-world datasets.

Methods: Patients included were registered in MSBase or the TYSABRI Observational Program (TOP), had relapsed on IFNβ or GA within 12 months prior to switching to another therapy, and had initiated natalizumab or IFNβ/GA treatment ≤6 months after discontinuing prior therapy. Covariates were balanced across post switch treatment groups by propensity score matching at treatment initiation. Relapse, persistence, and disability measures were compared between matched treatment arms in the total population (n = 869/group) and in subgroups defined by prior treatment history (IFNβ only [n = 578/group], GA only [n = 165/group], or both IFNβ and GA [n = 176/group]).

Results: Compared to switching between IFNβ and GA, switching to natalizumab reduced annualized relapse rate in year one by 65-75%, the risk of first relapse by 53-82% (mean follow-up 1.7-2.2 years) and treatment discontinuation events by 48-65% (all P ≤ 0.001). In the total population, switching to natalizumab reduced the risk of confirmed disability progression by 26% (P = 0.036) and decreased the total disability burden by 1.54 EDSS-years (P < 0.0001) over the first 24 months post switch.

Interpretation: Using large, real-world, propensity-matched datasets we demonstrate that after a relapse on IFNβ or GA, switching to natalizumab (rather than between IFNβ and GA) led to superior outcomes for patients in all measures assessed. Results were consistent regardless of the prior treatment identity.

No MeSH data available.


Related in: MedlinePlus