Sunday, 20 September 2015

Data suggest switch to Fingo not CRAB drugs after tysabri

Iaffaldano P, Lucisano G, Pozzilli C, Brescia Morra V, Ghezzi A, Millefiorini E, Patti F, Lugaresi A, Zimatore GB, Marrosu MG, Amato MP, Bertolotto A, Bergamaschi R, Granella F, Coniglio G, Tedeschi G, Sola P, Lus G, Ferrò MT, Iuliano G, Corea F, Protti A, Cavalla P, Guareschi A, Rodegher M, Paolicelli D, Tortorella C, Lepore V, Prosperini L, Saccà F, Baroncini D, Comi G, Trojano M; Italian iMed-Web database Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis. Brain. 2015 Sep 11. pii: awv260. [Epub ahead of print]

The comparative effectiveness of fingolimod versus interferon beta/glatiramer acetate was assessed in a multicentre, observational, prospectively acquired cohort study including 613 patients with relapsing multiple sclerosis discontinuing natalizumab in the Italian iMedWeb registry. First, after natalizumab suspension, the relapse risk during the untreated wash-out period and during the course of switch therapies was estimated . 

During the wash-out period an increased risk of relapses was found in patients with a higher number of relapses before natalizumab treatment (incidence rate ratio = 1.31, P = 0.0014) and in patients discontinuing natalizumab due to lack of efficacy (incidence rate ratio = 2.33, P = 0.0288), patient's choice (incidence rate ratio = 2.18, P = 0.0064) and adverse events (incidence rate ratio = 2.09, P = 0.0084). 

The strongest independent factors influencing the relapse risk after the start of switch therapies were a wash-out duration longer than 3 months (incidence rate ratio = 1.78, P < 0.0001), the number of relapses experienced during and before natalizumab treatment (incidence rate ratio = 1.61, P < 0.0001; incidence rate ratio = 1.13, P = 0.0118, respectively) and the presence of comorbidities (incidence rate ratio = 1.4, P = 0.0097). 

Switching to fingolimod was associated with a 64% reduction of the adjusted-risk for relapse in comparison with switching to interferon beta/glatiramer acetate (incidence rate ratio = 0.36, P < 0.0001).  The cumulative probability of a first relapse after the treatment switch was significantly lower in patients receiving fingolimod than in those receiving interferon beta/glatiramer acetate (P = 0.028). The robustness of this result was also confirmed by sensitivity analyses in subgroups with different wash-out durations (less or more than 3 months). Time to 3-month confirmed disability progression was not significantly different between the two groups (Hazard ratio = 0.58; P = 0.1931). 

Our results indicate a superiority of fingolimod in comparison to interferon beta/glatiramer acetate in controlling disease reactivation after natalizumab discontinuation in the real life setting.

This study says that if you stop natalizumab and switch to fingo you have less risk of relapse than if you switch to the CRAB drugs.

This message is published in one of the higher quality journals but Duh! 

It is amazing that this study happens as it should be a no brainer that this result will happen. 

I was at lunch today with  one of the neuros and they were proverbially banging their head against a wall, because some of their colleagues can't seem to grasp that we should aim for NEDA and the CRAB drugs are just not good enough for most.

2 comments:

  1. Instead of connecting heads with walls, maybe aiming boots at backsides (as I suggested a couple of days ago) would provide more satisfaction - at least for the booter even if not for the bootee!

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  2. "Time to 3-month confirmed disability progression was not significantly different between the two groups" ... How to interprate this part of the result? Does it mean that fingolimod supress only the inflammatory component of the deases?

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