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Thread: ECTRIMS 2016: Rituximab (Rituxan) in MS: data from Swedish MS registry

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    Distinguished Community Member agate's Avatar
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    Default ECTRIMS 2016: Rituximab (Rituxan) in MS: data from Swedish MS registry

    Presented at the annual ECTRIMS conference (London, September 14-17, 2016):

    Rituximab in multiple sclerosis; data from the Swedish MS registry

    P. Alping1, A. Svenningsson2, J. Salzer3, J. Burman4, C. Dahle5, K. Fink1, J. Hillert1, J. Lycke6, A.-M. Landtblom4, C. Martin2, P. Nilsson7, F. Walentin8, T. Olsson1, T. Frisell9, F. Piehl1

    1Clinical neuroscience, 2Clinical Science Danderyd┤s Hospital, Karolinska Institutet, Stockholm, 3Pharmacology and Clinical Neuroscience, Umeň University, Umeň, 4Neuroscience, Uppsala University, Uppsala, 5Clinical and Experimental Medicine, Link÷ping University, Link÷pin, 6Clinical Neuroscience and Rehabilitation, University of Gothenburg, Gothenburg, 7Neurology, Lund University, Lund, 8Neurology, Írebro University Hospital, Írebro, 9Medicine Solna, Karolinska Institutet, Stockholm, Sweden

    Background:

    Rituximab (RTX) is a monoclonal anti-CD20 B-cell depleting antibody. Two smaller randomized studies in MS have shown promising effects of RTX, both in relapsing-remitting MS (RRMS) and in primary progressive MS (PPMS).

    Furthermore, in an observational study we recently found that disease reactivation after terminating natalizumab due to positive JC-virus serology was much lower for RTX compared with fingolimod (Alping et al., Ann Neurol2016 PMID: 27038238). In Sweden the off-label use of RTX for MS, especially in JCV+ RRMS and inflammatory active progressive MS, has increased rapidly over the last years.

    Objective:

    To describe and compare baseline characteristics and outcomes for patients starting RTX, FGL, or NTZ therapy, for MS, in Sweden, using data from the Swedish MS register (SMSreg).

    Methods:

    Baseline and follow up data on all patients treated with RTX, FGL, and NTZ were retrieved from the SMSreg.

    Results:

    In our preliminary data set, we identified 2041 MS patients treated with RTX (until 1 Dec 2015). These patients correspond to 25.3% of all patients with disease modulatory treatment, or 14.9% of all active MS patients in SMSreg. The mean age was 43.6 years, 68.9% were female, and the listed disease course was 68.4% RRMS, 23.6% secondary progressive MS (SPMS) and 6.1% PPMS. The mean disease duration was 11.3 years and the mean treatment duration 21.1 months.

    At start of therapy the mean expanded disability status scale (EDSS) was 3.22, symbol digit modalities test (SDMT) 50.8, multiple sclerosis impact scale-29 (MSIS) 1.94 (physical) and 2.30 (psychological), respectively. The proportion of patients who terminated RTX therapy for all reasons was 9.3%.

    Additional data on effects over time on EDSS, SDMT and MSIS-29 will be included in the final presentation, as well as corresponding data for the FGL and NTZ cohorts.

    Conclusions:

    We here report the largest cohort of MS patients treated with RTX over an extended period of time. Preliminary results indicate that RTX demonstrates a high degree of drug survival, with few treatment interruptions due to an inadequate treatment response or adverse events. Furthermore, we will also present a comparison between RTX, FGL, and NTZ, thus shedding further light on the role RTX in the treatment of MS.

    ______________
    Disclosure:

    Peter Alping and Thomas Frisell; nothing to disclose.
    Anders Svenningsson has received travel support and/or lecture honoraria from Biogen, Merck Serono, Genzyme, Novartis and Baxter, and has received unconditional research grants from Bayer Schering Pharma and Biogen.
    Jonatan Salzer has received lecture honoraria from Biogen, Teva and Genzyme and has received travel support from Biogen and research support from Synapsys.
    Joachim Burman has received travel support and/or lecture honoraria from Almirall, Biogen, Genzyme, Hospira and MerckSerono, and has received unconditional research grants from Biogen and MerckSerono.
    Charlotte Dahle has received unrestricted research grants or honoraria for lectures or advisory boards from Biogen, Novartis, Merck Serono, Teva and Genzyme.
    Katharina Fink has received an unrestricted academic research grant from Biogen and compensation for lectures from Biogen and Novartis, which have been exclusively used to support research activities.
    Jan Hillert has received honoraria for serving on advisory boards for Biogen and Novartis, speaker's fees from Biogen, MerckSerono, Bayer-Schering, Teva and Sanofi-Aventis and received unrestricted research support from, Biogen, MerckSerono, Genzyme and Novartis.
    Anne-Marie Landtblom has received honoraria from MerckSerono, Teva, Biogen and Genzyme.
    Jan Lycke has received travel support and/or lecture honoraria from Bayer Schering Pharma, Biogen, Novartis, Teva and Genzyme , has served on scientific advisory boards for Almirall, Teva, Biogen, Novartis and Genzyme, has received unconditional research grants from Biogen, Novartis and Teva, and serves on the editorial board of the Acta Neurologica Scandinavica.
    Claes Martin has received honoraria for lectures and advisory boards from Biogen, Novartis, Merck Serono, Teva and Genzyme.
    Petra Nilsson has received travel support from Bayer Schering Pharma, MerckSerono, Biogen and Genzyme, honoraria for lectures and advisory boards from MerckSerono and Genzyme, compensation for participation in advisory boards for Novartis and Roche, lectures for Biogen and has received unrestricted grants from Biogen.
    Fredrik Walentin has received research grants from Biogen and MerckSerono.
    Tomas Olsson has received compensation for lectures and /or advisory boards, or unrestricted MS research grants from Biogen, Allmiral, Novartis, Genzyme, Astrazeneca and MerckSerono.
    Fredrik Piehl has received unrestricted academic research grants from Biogen, Genzyme and Novartis, and travel support and/or compensation for lectures and/or participation in advisory boards from Biogen, Merckserono, Novartis, Genzyme and Teva, which have been exclusively used for the support of research activities.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    It seems the drug is from Genetech - Biogen. Almost every author is supported, in part, by Biogen.

    ANN
    There comes a time when silence is betrayal.- MLK

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    Distinguished Community Member agate's Avatar
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    Isn't it astonishing how many disclosures so many authors have? Seems as if just about every neurologist who is named in any research paper has "disclosures" about ties to drug companies.

    The few who have nothing to disclose are rare--two of the many authors of this article.

    Of course some of the ties to drug companies are probably trivial--a very small amount of money changing hands. I'm not excusing them--just saying that there are many sides to the story.

    If I were a doctor I'd be looking for remedies for my patients' illnesses, and I'd probably be willing to cut a few deals with companies that were selling the most promising remedies. I might agree to give a speech at an event sponsored by one of the drug companies, and I'd be paid an honorarium for my time. Often the honorarium comes to far more than my time is typically worth, but there'd be transportation costs, and maybe I spent time preparing extensively for the lecture. This strikes me as less obnoxious than accepting outright gifts from the pharma people.

    But would those promising remedies mean "promising" for my patients' health? Or would it mean "promising" in terms of money-making for the stockholders, and as a doctor I might be among them?

    That's a question I have no answer to.

    There seem to be doctors who care about their patients' health first and foremost, and there are those who have set their sights on making a lot of money--as well as becoming big names in their field, invited to talk shows, hobnobbing with the glitterati. Unfortunately.

    (--Shouldn't have climbed onto this soapbox. I could easily stumble getting off it....)
    Last edited by agate; 09-20-2016 at 01:19 PM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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