Biologics are all the rage for the treatment of autoimmune conditions and they’re quite the darling of the clinical research world. One, because they’re relatively new – Humira, for example, was approved for treatment just a decade ago – this is yesterday for clinical research, and two, they show a lot of potential not only for the treatment of autoimmune diseases but also for further diversification.

We talked about biologics a while ago on the FindMeCure blog but in short, biologics are drugs made from living organisms grown in laboratories and tailored so that they bind to specific proteins involved in the process of inflammation.

Although highly effective, biologic therapies have a bad rap in some patients communities because their potential side effects can be severe and are certainly not to be underestimated. IBD patients, in particular, have a lot of questions about biologics and what could potentially go wrong if they decide to give them a chance.

So, before you give in to fear and strike off a therapy that could significantly improve your symptoms or even reverse some of the damage of IBD, let’s talk about biologics. We have picked some of your most urgent questions about biologic therapies and we’re going to do our best to answer them in an unbiased, realistic, no-sugar-coating way but if we have failed to address one of your concerns, feel free to ask your question in the comments.     

1. Will I get tuberculosis?

If you’ve ever read anything about biologics for Crohn’s disease or ulcerative colitis, two things have probably made you shiver – tuberculosis and lymphoma listed under ‘potential side effects’. Now, they’re not listed under ‘common side effects’, mind you, but even the slightest possibility of getting a serious infection or even cancer as a result of your treatment can be enough to make you reconsider.

Well, don’t do it in a rush at least. One, Humira, Cyltezo, and Amjevita don’t cause tuberculosis – they can simply trigger it if you are already exposed to it because they interact with the immune system in a way that makes you more susceptible to infections. Two, the risk of developing cancer like lymphoma, although slightly increased for people who take a biologic, remains low.

According to 2009 research, analyzing the risk of developing lymphoma when taking a combination of biologic and immunomodulator therapy compared to healthy people (1 in 10 000) IBD patients treated with a combination of immunomodulator and an anti-TNF biologic have a 6 in 10 000 risk of developing lymphoma.

However, keep in mind that these statistics reflect the risk of patients treated with combination therapy and don’t take into account the effects of integrin antagonist biologics, only anti-tumor necrosis factor (anti-TNF) ones. Clearly, more research is needed and actually, biologics are being continuously tested, so new data is bound to make its appearance in the next few years.  

2. Why do biologics have so many side effects?

Okay, we hear you say, but why the scary side effects? Well, for starters, all drugs have potential side effects and some of them are quite scary too – we just don’t hear a lot about them, because they’re not so common.

The common side effects of biologics often include irritation at the site of injection – a rash, some swelling, some redness, possibly bruising. The truth is that biologics are well tolerated by the majority of patients – otherwise they wouldn’t get FDA approval.

However, the way biologics work opens the door for infections. As we said earlier, biologics contain antibodies that disrupt the process of inflammation by interacting with the immune system – binding to key for the immune response proteins. As a result, they may leave you vulnerable to bacteria, viruses or fungi. The actual percentage of patients who get infections while on biologic therapy, however, is relatively small – between 5 and 7, depending on the type of biologic.

To assess your own risk of developing an infection, you’d have to take into account your age, general health condition, medical history, immunizations and so on.

You’ll need to inform your doctor about every other medication or supplement you might be taking and schedule regular check-ups. Be mindful of all flu-like symptoms and immediately turn to your doctor if you have a fever or a cough – biologics are associated with an increased risk of upper respiratory tract infections in particular.       

3. Should I receive vaccinations before I start treatment?

Staying on top of your immunization schedule should always be a priority but even more so if you have an IBD and future biologic treatment is possible. You should talk to your doctor about getting all the recommended vaccinations if you haven’t received them already as a precaution against possible infections.

It’s really up to you and your primary physician whether you get all the seasonal flu shots. But keep in mind that while a healthy person might afford the risk of sacrificing a few days to the flu, someone who takes a biologic is at greater risk of developing an infection and prevention is the best tactic they can rely on, since their immune system is, in a way, suppressed.

Vaccines that contain a live virus are to be avoided after a biologic therapy has started but other immunizations can still be completed during the course of treatment if needed. You should be able to schedule most of your important immunizations before the treatment begins but if you need to be vaccinated later on, as long as the vaccine doesn’t contain a live virus, you should be okay.   

4. Do I have to take a biologic?

Up until recently, biologic therapy was thought of as a sort of a ‘last resort’ for patients who no longer benefit from other types of treatments – like corticosteroids or immunomodulators. The side effects, along with the price of treatment (that not all insurance companies cover, so check your plan) made doctors a bit reluctant to recommend them to patients who were otherwise doing well on ‘standart’ treatment.

A 2018 study on the role of biologics in IBD, however, comes to the conclusion that with increased evidence for the beneficial effects of biologics practices are shifting to introduce early use as well as focus on treating rather than limiting damage.

So, the short answer is no. If you have mild to moderate Crohn’s or ulcerative colitis and your symptoms improve on corticosteroids, for example, you may not need to consider biologics – you might never have to.

However, biologics are on focus in the clinical research world now and they get better and better at treating inflammation early on. With the wider introduction of biosimilars, prices are also coming down to make biologic therapy not only effective but also affordable.    

5. What are the benefits of taking a biologic?

Fair question – after listing all the potentially severe side effects, what are the benefits that can make you consider a biologic? We need to get this out of the way – though biologics are very similar in the way they work, each biologic is slightly different from the next one. So the benefits really depend on the particular drug you’re taking and how it interacts with your organism.

But generally speaking, biologics are very effective at reducing inflammation and paving a path to lasting remission. Not only that, but some of them show the potential of significantly limiting and even healing the damage to the digestive tract.

Early treatment is associated with an optimistic prognosis of preventing future flare-ups and slowing the progression of Crohn’s or ulcerative colitis. This means not only fewer, less prominent symptoms but also potentially avoiding complications and the need for surgery later on.  

6. Do I need to go to my doctor every two weeks?

That depends on the kind of biologic you take. Biologics are given in two ways – an injection you or a loved one can learn how to administer or via IV in a clinic, your doctor’s office or an infusion center. It may sound tedious, going to your doctor every other week but only some of the biologics out there require this kind of time commitment. Others are administered once every 8 weeks and some you can learn to give to yourself. Each biologic has its own schedule.

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