The earlier the better; even non-highly effective DMTs have benefit

Are we throwing the baby out with the bathwater? Does interferon-beta have life left in it as a treatment for MS? #MSBlog #MSResearch

Epub: Nagtegaal et al. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2013 Jul 10.

BACKGROUND: MS is characterised by inflammatory lesions of the central nervous system. Interferon beta-1b (IFNB-1b) has been shown to improve clinical and magnetic resonance imaging (MRI) measures for MSers.

OBJECTIVE: To evaluate whether IFNB-1b in CISers prevents persisting T1 hypointensities on MRI (persistent black holes (PBHs)).

"Black holes left behind are and indication or loss of nerves and axons. Lesions that cause black holes on MRI are more destructive than lesions that don't leave black holes."

METHODS: In the placebo-controlled phase, CISers (n = 468) were initially randomised to IFNB-1b (n = 292) or placebo (n = 176) for two years or clinically definite MS (CDMS). In the open-label phase (n = 418), both groups were offered IFNB-1b for up to five years. Lesions were classified as PBHs if T1 hypointensity persisted throughout the last available scan (minimum time one year).

RESULTS: A total of 435 CISers were evaluable for analysis. The number of PBHs/patient was lower in the early rather than the delayed treatment arm during both phases (0.42 vs 0.71, p = .0102 and .70 vs 1.17, p = .0121). Exploratory analyses identified baseline characteristics that affected rate of conversion.

CONCLUSIONS: Although the rate of lesions that converted to PBH showed no significant differences between groups, the numbers of PBHs per CISer out of new lesions was significantly lower in IFNB-1b patients compared to patients on placebo. 



"Maybe we shouldn't throw the baby out with the bathwater. If interferon-beta works why replace it with the newer agents? The problem is that the majority of MSers will ultimately fail interferon therapy. It is a great pity we don't have predictive markers to help us decide which MSers is going to be a responder or a non-responder. At the moment we put you on interferon beta and watch and see what happens. If you have relapses , or progress, or develop new lesions on MRI, or develop NABs we say you are a non-responder and if you remain stable we say you are a responder. The problem with this is that while we wait 12, 24, 36 or more months MS may continue to cause damage, or shred, your brain that is irreversible. This is why a lot of neurologists who have access to more effective treatments early are using them as first-line agents. Then there is also the issue of side effects and tolerance issues; some MSers don't like to inject themselves and don't like the flu-like side effects and skin reactions. It is all very complicated, which is why DMT decisions have to be personalised. 

"The message from this study is clear; interferon beta when used as early as possible in CISers works and reduces black holes or tissue destruction. This is reassuring to know. The problem we have in the UK is  that NICE and the Department of Health won't allow us to use interferon beta after the first clinical event; we have to wait until the second attack and we can only start interferon if that second attack occurs witin 2 years of the first attack. While we wait for the second attack to happen MS may be active and continue to damage or shred your brain. No wonder MSers and neurologists in the UK feel let down."

CoI: multiple

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