Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing–remitting multiple sclerosis

Kalinčík, Tomáš; Jokubaitis, Vilija; Izquierdo, Guillermo; Duquette, Pierre; Girard, Marc; Grammond, Pierre; Lugaresi, Alessandra; Oreja‐Guevara, Celia; Bergamaschi, Roberto; Hupperts, Raymond; Grand’Maison, François; Pucci, Eugenio; Pesch, Vincent Van; Boz, Cavit; Iuliano, Gerardo; Fernández‐Bolaños, Ricardo; Flechter, Shlomo; Spitaleri, Daniele; Cristiano, Edgardo; Verheul, Freek; Lechner‐Scott, Jeannette; Amato, Maria Pia; Cabrera-Gómez, José Antonio; Saladino, Maria Laura; Slee, Mark; Moore, Fraser; Gray, Orla; Paine, Mark; Barnett, Michael; Havrdová, Eva; Horáková, Dana; Spelman, Tim; Trojano, María; Butzkueven, Helmut

doi:10.1177/1352458514559865

Cited by 36 publications

(26 citation statements)

References 32 publications

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“…ARRs derived by all variations of the algorithm were in good agreement, differing by less than 0.1 (data not shown). Furthermore, the ARRs reported here are in the same range as those reported from clinical trials and are consistent with the ARRs reported in studies of real-world data [17, 25]. Our study, therefore, provides further confirmation of the validity of this approach for determining ARR from claims data.…”

Section: Discussionsupporting

confidence: 90%

Comparative Effectiveness Research of Disease-Modifying Therapies for the Management of Multiple Sclerosis: Analysis of a Large Health Insurance Claims Database

Boster

Nicholas

et al. 2017

Neurol Ther

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IntroductionLimited data are available on the real-world effectiveness of newer oral disease-modifying therapies (DMTs) in multiple sclerosis. The purpose of this study was to retrospectively compare the real-world effectiveness of dimethyl fumarate (DMF), fingolimod, teriflunomide, and injectable DMTs in routine clinical practice based on US claims data.MethodsPatients newly-initiating DMF, interferon beta (IFNβ), glatiramer acetate (GA), teriflunomide, or fingolimod in 2013 were identified in the Truven MarketScan Commercial Claims Databases (N = 6372). Relapse episodes were identified based on a published claim-based algorithm and used to determine the annualized relapse rate (ARR) for the year before and after initiating therapy. Poisson and negative binomial regression was used to determine the adjusted incidence rate ratio (IRR) for each therapy relative to DMF.ResultsSignificant ARR reductions in the year after initiating therapy were reported for DMF and fingolimod (P < 0.0001). Compared with DMF, the adjusted IRR (95% CI) for relapse in the year after initiating therapy was 1.27 (1.10–1.46) for IFNβ, 1.34 (1.17–1.53) for GA, 1.23 (1.05–1.45) for teriflunomide, and 1.03 (0.88–1.21) for fingolimod. Results were consistent across subgroup and sensitivity analyses.ConclusionThese real-world data suggest DMF and fingolimod have similar effectiveness and demonstrate superior effectiveness to IFNβ, GA, and teriflunomide. Funding: Biogen, Cambridge, MA, USA.Electronic supplementary materialThe online version of this article (doi:10.1007/s40120-017-0064-x) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 90%

Comparative Effectiveness Research of Disease-Modifying Therapies for the Management of Multiple Sclerosis: Analysis of a Large Health Insurance Claims Database

Boster

Nicholas

et al. 2017

Neurol Ther

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“…Various studies report real-world data for GA treatment in RRMS [72,73,75,76], confirming the efficacy profile of GA observed in the clinical studies. A significant impact of the treatment with GA on health-related quality of life has also been reported [77,78], with beneficial effects including significant reductions in fatigue and in days of absence from work.…”

Section: Once-daily Formulation In Relapsing-remitting Multiple Sclermentioning

confidence: 64%

“…Moreover, there have been no reports of rebound effect or delayed disease reactivation after treatment discontinuation in extensions of clinical trials or postmarketing studies [63,70,72,73].…”

Section: Once-daily Formulation In Relapsing-remitting Multiple Sclermentioning

confidence: 99%

The heritage of glatiramer acetate and its use in multiple sclerosis

Comı

Amato

Bertolotto

et al. 2016

Mult Scler Demyelinating Disord

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Multiple sclerosis (MS) is a chronic and progressively debilitating disease of the central nervous system. Treatment of MS involves disease-modifying therapies (DMTs) to reduce the incidence of relapses and prevent disease progression. Glatiramer acetate (Copaxone®) was the first of the currently approved DMTs to be tested in human subjects, and it is still considered a standard choice for first-line treatment. The mechanism of action of glatiramer acetate appears to be relatively complex and has not been completely elucidated, but it is likely that it involves both immunomodulating and neuroprotective properties. The efficacy of glatiramer acetate 20 mg/mL once daily as first-line treatment in relapsingremitting MS is well established, with ample evidence of efficacy from both placebo-controlled and active-comparator controlled clinical trials as well as real-world studies. There is also a considerable body of evidence indicating that the efficacy of glatiramer acetate is maintained in the long term. Clinical trial and real-world data have also consistently shown glatiramer acetate to be safe and well tolerated. Notably, glatiramer acetate has a good safety profile in women planning a pregnancy, and is not associated with foetal toxicity. Until recently, glatiramer acetate was only approved as 20 mg/mL once daily, but a new formulation with less frequent administration, 40 mg/mL three times weekly, has been developed and is now approved in many countries, including Italy. This review examines the mechanism of action, clinical efficacy, safety and tolerability of glatiramer acetate to provide suggestions for optimizing the use of this drug in the current MS therapeutic scenario.

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“…Sex, age, EDSS, disease duration, and the count of both total relapses and steroid-treated relapses in the 12 and 24 months prior to baseline were used to 1:1 match patients employing a 5:1 digit "greedy" matching algorithm as previously described by this study group. [21][22][23]27 As a sensitivity analysis, clinic country was included for the derivation of the propensity score. A 1:1 match was preferred over a 1-to-many match as the latter introduced unacceptable imbalance secondary to the poorer quality of the secondary and tertiary matches.…”

Section: Methodsmentioning

confidence: 99%

“…Wilcoxon rank-sum for continuous factors and a x 2 test for categorical variables were used to compare unmatched baseline characteristics by treatment arm. [21][22][23] A Cox marginal model was used to test for differences in time to first on-treatment relapse event, treatment persistence, and disability progression by treatment arm. Scaled Schoenfeld residuals were used to test each model for underlying hazard proportionality.…”

Section: Methodsmentioning

confidence: 99%

Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS

et al. 2016

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Background: We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-b (IFNb)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries. Methods: The study population initiated IFN-b/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had $3 months of on-treatment follow-up, and had active RRMS, defined as $1 gadoliniumenhancing lesion on cerebral MRI at baseline or $1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensitymatched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n 5 366/group) and subgroups with higher baseline disease activity.Editorial, page 97 *These authors contributed equally to this work.

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Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing–remitting multiple sclerosis

Cited by 36 publications

References 32 publications

Comparative Effectiveness Research of Disease-Modifying Therapies for the Management of Multiple Sclerosis: Analysis of a Large Health Insurance Claims Database

Comparative Effectiveness Research of Disease-Modifying Therapies for the Management of Multiple Sclerosis: Analysis of a Large Health Insurance Claims Database

The heritage of glatiramer acetate and its use in multiple sclerosis

Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS

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