Epub: Nagtegaal et al. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2013 Jul 10.
OBJECTIVE: To evaluate whether IFNB-1b in CISers prevents persisting T1 hypointensities on MRI (persistent black holes (PBHs)).
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.