Meng X, Chin PS, Hashmonay R, Zahur Islam M, Cutter G. Effect of Switching From Intramuscular Interferon β-1a to Oral Fingolimod on Time to Relapse in Patients With Relapsing-Remitting Multiple Sclerosis Enrolled in a 1-Year Extension of TRANSFORMS. Contemp Clin Trials. 2014 Dec 26. pii: S1551-7144(14)00196-7. doi:
#MSResearch Gilenya is more effective than interferon beta at least in terms of efficacy.
BACKGROUND: In the absence of controlled, parallel-group studies, statistical methods developed to estimate treatment effects in patients receiving alternative/rescue treatment in clinical trials may be used to estimate the effects of multiple sclerosis (MS) therapy switch using available clinical trial data.
OBJECTIVE:To use TRANSFORMS data and parametric models to assess the time to first confirmed relapse in MS patients who switched from intramuscular interferon β-1a (IFNβ-1a IM) 30μg/mL once weekly to oral fingolimod 0.5 or 1.25mg once daily vs. remaining on IFNβ-1a IM.
RESULTS:Results showed that fingolimod 0.5 and 1.25mg prolonged time to relapse, with an estimated median time to first relapse of 5.07 years (P=0.0026 vs. IFNβ-1a IM) and 4.11years (P=0.0113), respectively, versus 2.26 years with IFNβ-1a IM. The estimated ratio of observed time to first confirmed relapse to the estimated time had the patient remained on IFNβ-1a IM was 2.09 (95% CI, 1.45-3.04) for switching to fingolimod 0.5mg and 1.84 (95% CI, 1.30-2.65) for switching to fingolimod 1.25mg.
CONCLUSION:During the extension, time to first confirmed relapse was approximately doubled in patients switching from IFNβ-1a IM to fingolimod. These analytic methods may be useful in evaluating treatment switch effects in clinical trials with extension data.
The clinical trial data indicates that fingolimod is more effective than beta interferon. In this study it was shown in a head to head between Gilenya and Avonex in a trial where interferon beta users were switched to Gilenya verses remaining with beta interferon.
It was shown that the time to the next relapse was doubled with one relapse every 4-5 years compared to one every 2 and a bit years.
So this is telling us what we already know and to show that Gilenya is more effective than interferons is just extra marketing data targeting low hanging fruit. What happens when we put Gilenya against other more active DMT?
However the problem in the UK, is that Gilenya is considered a second line therapy and so you need to fail a first line therapy first before you get the option of something more effective. The granting of first line status to Alemtuzumab kind of makes a mockery of this based on safety profiles.
However I suspect the second line rank in the UK was based on cost and had Gilenya not costed twice as much as the old first line stable, maybe this would be different.
It will be interesting to see what happens to the Me-toos when they hit the streets...first line I suspect as the landscape has changed a lot since Gilenya was the first DMT pill to be approved.
CoI None...ProfG multiple
Labels: axonex, Beta Interferon, fingolimod, Gilenya