Do You Know Nocebo (and It’s Effect on Biosimilars)?

I love words and one that has entered my vocabulary since my RA diagnosis is, “nocebo.”

I think most of us know what a placebo is – a harmless pill/medicine that is often used as a baseline to test the effect of another drug. It’s also a pill or medication that is used more for the positive psychological effect on the patient than any real medical benefit. Think of the old country doctor passing out sugar pills that “cured” many of his patients. They believed the pills would work, so they did.

A nocebo, on the other hand, is a negative or detrimental effect on health because of factors such as a patient’s perception or expectations. In this case, the patient doesn’t expect the drug/treatment to work so it often fails.

So what does this have to do with biosimilars?

As you are no doubt aware, biosimilars are biologic medications that have been developed to be similar to an existing, approved drug that’s already on the market (also known as the “reference drug”). For example, there is a drug called Inflectra that is a biosimilar to Remicade, one of the early biologic drugs approved for rheumatoid arthritis. Biologics are very complex medicines so there is no such thing as a “generic” biologic (which would be the exact drug). Rather, biosimilars are designed to work in the same manner and have the effectiveness as the original, reference drug. The jury is still out on what the long-term effect will be on cost, but it’s hoped that biosimilars will provide a less-expensive alternative and thereby make these advanced treatments more affordable.

However, a recent study reported by the Center for Biologics indicates that there may be a nocebo effect when it comes to biosimilar use. In blind studies where patients didn’t know if they were on the original drug or the biosimilar, they discontinued the drugs at about the same rate (due to lack of effectiveness or because of adverse side effects). However, in clinical use, when the patient knew they were on a biosimilar, the discontinuation rate was much higher.

So why was the discontinued rate about the same in blind studies, but higher when the patient knew they were on a biosimilar? The initial conclusion is a nocebo effect. This conclusion is supported in part by how much information a patient had about biosimilars. Patients who were better educated about biosimilars were more likely to stay on the drug than those patients who knew less about the drugs.

There is no question that there is a great deal of education about biosimilars to be done at all levels – from the patients to the physicians and even to the legislative/regulatory levels. However, it’s concerning that patients apparently aren’t being given the information they need about the medications they’re being prescribed. This can result in failed treatments and a higher rate of complications and doctor visits.

This is one of the great things I love about community. There are so many terrific resources, including those here on rheumatoidarthritis.net where you can find both “official” information and actual patient experiences. As busy as our health care providers are, it has (fortunately or unfortunately) been put upon our shoulders to become informed patients. The good news is, we now have the means to do so.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The RheumatoidArthritis.net team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

Comments

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  • Carla Kienast author
    1 year ago

    Rick: This is an excellent point and, in addition to your on-point comments, underscores a couple of things. First, biologics are actually grown and are not chemical compounds as many medications are, such as aspirin. Therefore, every batch is different (and thus a biosimilar as you pointed out) and there isn’t a true “generic”. The other point is that there needs to be a lot of education done about biosimilars for everyone — from patients to healthcare professionals to regulators and legislators. This kind of discussion in our community certainly furthers that cause. Thanks so much for sharing this information!

  • Lawrence 'rick' Phillips
    1 year ago

    I learned something at ACR that absolutely changed my mind about BioSimilars. It turns out that no matter the biologic medication no two batches are the same. Instead the biologic you receive is only similar to the biologic I receive even if we have the same dose, from the same company, on the same day but yours form batch A and mine form batch C. Why? Because each batch is unique. Yes they have similar characteristics and yes both doses might be perfectly composed. But no matter they will be different.

    Hence each of these medications we receive might be considered BioSimilar. That is why the batches of one drug are different in Europe than the US even if the same breeder colonies are used. These batches of biologic material will be different.

    This information helped me understand two things, first BioSimilars are safe to try and second, I have been using only versions of themselves for years. No wonder sometimes they work and sometimes not. Ha, who knew?

  • Richard Faust moderator
    1 year ago

    Thanks so much for making a very important point Rick. One of the keys is that the drugs must have the same mechanism of action (for example if the original is a TNF Inhibitor, so is the biosimilar). Beyond that are rules for such things as similar efficacy, potency, and safety (amongst other things). This is still simplifying complex definitions. More information on what makes something a biosimilar is in this article from one of our contributors: https://rheumatoidarthritis.net/living/biosimilars-not-generics/. Best, Richard (RheumatoidArthritis.net Team)

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