Research Summary: Evaluating the safety of β-interferons in MS

Research from the University of British Columbia has looked at the long-term health effects of interferon-beta treatment in people with multiple sclerosis.  This study has just been published in Neurology.

Assessing real-world treatment outcomes is important for a number of reasons.  Obviously, the safety of treatments is something that is checked during clinical trials.  For a treatment to be approved, it must show that there are no significant safety concerns associated with its use and that the benefits outweigh any side-effects that may occur.

However, this process in clinical trials doesn’t always completely reflect the outcomes in the real world for a number of reasons.  Firstly, clinical trials tend to be conducted over a short period of time, so no information is gathered about any health impacts from extended use.  Secondly, the participants in these trials are usually selected on the basis of having minimal other health issues.  This means that the people taking the medication once it enters the market are often quite different to those that were tested during the study period.  For these reasons, it becomes really important to continue to monitor the safety profile of any new treatment across the long-term in real world populations.

In this current study, the researchers looked at almost 2500 people with relapsing-remitting multiple sclerosis (RRMS) that had been using interferon-beta as their sole treatment choice.  Looking at their health records across the duration of time they were on the treatment (and comparing them to controls), they were able to see that interferon-beta appeared to slightly elevate the risk of stroke (1.8 times higher), migraine (1.6 times higher), depression and blood abnormalities (both 1.3 times higher).  Whilst migraine, depression and blood abnormalities are already listed in the safety profile for interferon-beta, the increased risk of stroke hasn’t previously been identified.

On the other hand, the study also showed that treatment with interferon-beta for more than 2 years could reduce the risk of bronchitis or other upper respiratory infections.  This finding has been suggested by previous studies, meaning this investigation provides more evidence to support that outcome.

Commenting on this study, Professor Helen Tremlett (a senior author on the study) says “Beta interferons are generally thought of as having a favourable safety profile, especially compared to the newer therapies for multiple sclerosis. And that is still the case; our study does not change that.  However, very few studies had comprehensively and quantitatively assessed their safety in real world clinical practice. Our findings complement and extend on previous observations.

The importance of the findings were also commented on by A/Prof Anthony Traboulsee (co-author on the study), who says “It is important for patients with multiple sclerosis to have ongoing review of the benefits and risks of therapy, and to identify supportive strategies, such as diet and exercise, that could optimize their brain health.

It is not suggested that these findings should cause any people with multiple sclerosis to alter their current treatment plan.  However, it is something that could be discussed with your healthcare professional if you are concerned.

Personally, I think this does showcase the importance of continuing to look into the real-world health impacts of multiple sclerosis treatments beyond the scope of clinical trials.  It is critical that we continue to listen to people with multiple sclerosis about their experiences with different medications, in terms of both side-effects and quality of life, and then to use these insights to re-frame the information we have learned about treatments during their initial testing phases.

The abstract for this study can be read in full here.

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