Tuesday, 7 June 2016

2016 Annual Meeting of the CMSC - trending in the posters

30th Annual Meeting of the Consortium of Multiple Sclerosis Centers; 1 June - 4 June 2016, National Harbor, Maryland.

As scientists, clinicians, people in general, we are content to follow sentiments from the latest book, TED talks and media in general with the customary hyperbole that willingly spurn concepts that don't suit our purpose, thereby swelling view points to the metaphorical ranks of truly regal proportions in our minds. In short, this is what conferences are about; if you discount the initial annoyances of Passport control and the Department For Transport (DaFT).

But the poster halls are taken up by the aspiring new (not yet jaded), pharma regalia and beverages (reminiscent of punch served at a debutante ball). I have selected a few of these below and will let you decide whether they meet your standards (keyword - real life experience).

Abstracts

(DX35) Relapse rates of patients with multiple sclerosis newly initiating subcutaneous Interferon Beta-1a versus oral disease-modifying drugs in the real world.
C Kozma, F Munschauer, A Phillips (supported by EMD Serono, manufacturers of Avonex IFN B1a)

Background: Administrative claims data provide information on outcomes in actual clinical care settings in a broader patient population (patients from IMS Lifelink PharMetric Plus database between 1/1/2012 and 6/30/2013).

Results: 1665 patients (686 scIFNB1a, 118 teriflunomide, 455 fingolimod, and 406 dimethyl fumarate) met inclusion criteria (mean age = 44.4 years; 75.5% female). Unadjusted analyses showed that MS-related hospitalizations and ER visits did not differ among DMDs; however, the proportion of patients with an MS-related outpatient relapse was lower in patients initiating scIFNB1a (19.7%) vs. teriflunomide (32.2%; P=0.003) and dimethyl fumarate (26.8%; P=0.039). Proportion of patients with >/= 1 MS relapse of any type was lower with scIFN1Ba vs. oral DMDs (21.7% and 26.1%, respectively, P=0.039). Logistic regression controlling for demographic and 90-day pre-index indicators showed that initiation of teriflunomide or dimethyl fumarate were associated with higher likelihood of relapse (odds ratio [OR] = 2.1; P=0.001 and OR = 1.5; P = 0.005, respectively) vs. scIFNB1a.

Conclusions: In this real-world population, after controlling for demographics and pre-index clinically meaningful indicators of disease severity, patients initiating scIFNb1a had a lower likelihood of experiencing surrogates for relapse in the first year than initiating teriflunomide or dimethyl fumarate.

(DX47) Key results from PREFERMS: Real-world patient retention and outcomes on Fingolimod versus platform injectable disease-modifying therapies in early relapsing-remitting multiple sclerosis
M Cascione, B AC Cree, D Wynn, X Meng, L Schofield, N Tenenbaum, on behalf of PREFERMS Investigators (supported by Novartis, manufacturers of Fingolimod)

Background: Suboptimal adherence to injectable disease-modifying therapy (iDMT) classes is well established. PREFERMS is the first large study of treatment retention with DMTs and other outcomes in patients with relapsing-remitting multiple sclerosis (RRMS). (PREFERMS was a 12-month, phase 4, open-label, active-controlled, randomized, multicenter study).

Results:  875 patients were randomized (fingolimod, n=436; iDMT, n=439). At baseline, mean time since diagnosis was 4.3 years and Expanded Disability Status Scale score was 2.4. In the full analysis set (n = 861), 352 (81.3%) patients on fingolimod and 125 (29.2%) on iDMT completed randomized treatment (P<0.01). Despite the shorter duration of exposure to iDMTs, the annualized relapse rate was numerically lower with fingolimod (ratio, 0.7; P=0.084). There was less brain volume loss (change from baseline at month 6, 0.19% vs. 0.31%, P=0.011); month 12, 0.40% vs. 0.56%, P=0.076), less cortical gray matter loss (change from baseline at last assessment 0.09% vs 0.29%; P=0.002), and treatment satisfaction was greater (medication satisfaction questionnaire: P<0.001, all assessments).

Conclusions: Higher therapeutic retention, improved clinical and radiographic outcomes, greater treatment satisfaction, and tolerability support fromt-line use of fingolimod over platform iDMTs in patients with early RRMS.

(DX51) Real-world comparison of relapse rates in multiple sclerosis patients treated with disease-modifying therapies
A Boster, J Nicholas, N Wu, W-S Yeh, M A Fay, M R Edwards, M-Y Huang, A Lee (Supported by Biogen, manufacturers of DMF)

Background: The effectiveness of disease-modifying therapies (DMTs) for multiple sclerosis (MS) has not been comprehensively studied in a real-world setting (this study used MarketScan, a large US commercial insurance database).

Results: A total of 3352 DMF (Dimethyl Fumarate), 1057 GS (Glatiramer Acetate), 884 IFN (Interferon), 579 FTY (Fingolimod), and 500 TER (Teriflunomide) were included in the analysis. Baseline differences were seen in age (46.7, 43.5, 43.6, 43.8, and 49.6, respectively; P<0.01), proportion of females (76.6%, 79%, 78.6%, 76.2% vs. 80%, respectively; P=0.21), proportion with other DMT in the prior year (68.7%, 15.7%, 13.5%, 64.2%, and 66%, respectively; P<0.01), and ARR in the prior year (0.43, 0.31, 0.37, 0.44, and 0.38, respectively; P<-.01). Using DMF as the reference, the adjusted incidence rate ratio was 1.34  (95% confidence interval [CI]: 1.17-1.530 for GA, 1.27 (1.10-1.46) for IFN, 1.03 (0.88-1.21) for FTY, and 1.23 (1.05-1.45) for TER.

Conclusions: DMF demonstrated significantly better effectiveness than GA, IFN, and TER in the real-world setting. No significant difference was observed between DMF and FTY.

14 comments:

  1. Background: The effectiveness of disease-modifying therapies (DMTs) for multiple sclerosis (MS) has not been comprehensively studied in a real-world setting (this study used MarketScan, a large US commercial insurance database).

    I don't understand...how can this be..? how long have DMT's been around.

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    Replies
    1. There's a simple explanation
      MS = cash cow for the drug companies
      Why would they want to do a study to work out which drugs work best in a real world setting?
      What we need now is a study looking at how Lemtrada and Cladribine do in the real world, being given to people who have had MS for years and have accumulated disability, as well as the recently diagnosed. I think we might wait a few years for that one.

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    2. We to study how CLAD works in the real world in people who have had MS years...shout "Comeon DrK get that study plan in and funded:-)"

      DrK has been gaining real life experience and has been giving people and option were there currently is none.

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    3. That's a question best posed to Pharma as a whole. It has become more pertinent as registries such as MS Base and NARCOMS have started reporting similar analysis. Companies such as IMShealth have begun to offer market research which now makes it easier for biotech's to answer these types of questions. What is lacking is the case composition of their databases - this needs to be made openly available.

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    4. Cordelia BrightburnTuesday, June 07, 2016 12:52:00 pm

      "What we need now is a study looking at how Lemtrada and Cladribine do in the real world, being given to people who have had MS for years and have accumulated disability, as well as the recently diagnosed. I think we might wait a few years for that one."

      We were turned down when trying to do part of your trial (comparing Alemtuzumab and Cladribine in people with relapsing MS), much of the story can be found here: http://multiple-sclerosis-research.blogspot.com/2016/01/white-knight-diaries.html

      We're now trying something different, however that requires preliminary data which we are working at. Hopefully submission in Sep, trial starting 2018...

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    5. This depends which one looks at. The first claimed that IFN is better. Was published by Neurology Advisor during CMSC 16 and the pulled it. Supported by the manf. of Avonex.

      The second is compliance in taking a med.

      The third is a real world comparison that displays Fingo & Dimethyl Fumarate had better results that copaxone, IFN and Aubagio.

      That third study sponsored by Biogen. However, I am very aware of one of the researchers involved in said study. The study results are stated to be real world and they appear to echo what clinical trials have shown.

      Additionally there appears to be some new ideas related to IFN as a additional therapy when using other therapies. SO! Why be on one when two is well.... TWO! Appears perhaps they are trying to keep the IFN's at market. There are people who use IFN's and done very well for many many years. I know a few (two). If IFN ends up a secondary or tertiary choice based on efficacy can they keep producing it towards profit?

      A doc not long back did a real world study of IFN and his data suggested IFN staved off SPMS for only two years longer than no therapy at all.

      One might FIGURE? some long term Copaxone results might exist towards that end? Cant find em'. The newer meds who knows? Roll the dice in lots of respects.

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    6. Such analysis would be advantageous for Teva to look into for copaxone. We're all aware of the UK risk sharing scheme results!

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  2. I'm sorry, did they second poster research find interferon superior to DMF and Ter? What?

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  3. Replies
    1. It would appear so, I'm sure the others would like to contest these conclusions. Although as I've said databases are only as good as their diversity.

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  4. In the real world what I have seen are people leaving and going of CRABS to DMDs, as DMF and FTY, by these fail to reduce relapses and disease progression ...

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    Replies
    1. We're back to the diversity of the data set again. I think it's time to invest in a global repository as new treatments enter the market to do real life comparisons.

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  5. Any chance you want to point us (URL) to the abstracts at this meeting or post them for us? It is very helpful to go through them on our own time. Gives those of us that are interested another method of learning what is happening in relation to our disease.

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  6. Hi Debbie, the abstract booklet hasn't been published yet but the titles of the abstract can be found on the meeting site cMSc meeting website. If you'd like more detail on any of these I can provide more details.

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