Tuesday, 21 February 2017

Real world data on efficacy or #alternativefact

Neurol Ther. 2017 Feb 16. doi: 10.1007/s40120-017-0064-x. [Epub ahead of print]

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


Boster A, Nicholas J, Wu N, Yeh WS, Fay M, Edwards M, Huang MY, Lee A.

Abstract

INTRODUCTION:

Limited 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.

METHODS:

Patients 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.

RESULTS:

Significant 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.

CONCLUSION:

These real-world data suggest DMF and fingolimod have similar effectiveness and demonstrate superior effectiveness to IFNβ, GA, and teriflunomide.

FUNDING:

Biogen, Cambridge, MA, USA.

In the way that social media has changed the face of news distribution once and for all, open access journals are steadfastly changing the face of science - for better or worse is a matter open to debate. Their 'free at point of access' policy means that their readership naturally increases with time compared to traditional paid journals. Open access journals may therefore become the modern-day equivalent of the unwitting accomplice for here-sayers and nay-sayers.

In MS therapeutics, as we have no head to head studies against the different disease-modifying therapies in MS, we are left with retrospective analysis of recorded data. In the case of the US, this would be the 'Commercial claims' insurance databases. Boster et al. (in a study funded by Biogen) claim that DMF (tecfidera) has similar effectiveness to fingolimod, but is SUPERIOR to the other first-line therapies (alemtuzumab and natalizumab were not included) (see Figure below). They justifiably point out that this can be explained by the non-compliance to therapy on injectables, but even controlling for this it would appear that DMF still comes out on top. The accuracy of data keeping and truthfulness of accounts is barely just touched upon.

The market size of DMF is sizable and that is food for thought. The fact that I have posted on this today will increase the altametrics of this article (Multiple Sclerosis BlogSpot averages on ~5000 page views/day). The alternative oral drug, Novartis's fingolimod (gilenya) is it's main competitor.

The authors conclude: "These data should assist in treatment decisions regarding the choice of DMT and enable clinicians to consider both real-world effectiveness and route of administration in consultations with their patients". In an attempt to be equally provocative I might add that biosimilars demonstrating equivalent efficacy are the poor man's alternative! It would be therefore reasonable to assume that in the current day #alternativefact, that almost nobody is flush with aces.

Figure: Unadjusted annualized relapse rates for 1 year before and 1 year after DMT initiation. DMT disease-modifying therapy

2 comments:

  1. ARR, ARR, ARR. What about BVL? As I know bvl correlates best with further disability! In this field fingo better than Dmf and near - but below - Nat! All in all dmf only moderately effective in overall! Horses and courses!

    ReplyDelete
    Replies
    1. Dmf and fingolimod have higher starting point same low point as others.
      Cladribine trial 0.15

      Delete

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