Things to Know About Biologics for Ankylosing Spondylitis

A drug class known as biologics may provide relief in some cases of ankylosing spondylitis (AS). This form of arthritis usually targets the vertebrae of the spine, causing pain and stiffness, but it can also affect other joints.

In more advanced cases of AS, inflammation can spur the formation of new bone. This can cause portions of the spine to become set in a fixed position. The upshot can be debilitating pain and stiffness.

There is as yet no cure for ankylosing spondylitis. Biologic agents, however, can make a difference by tamping down the body’s inflammatory response.

Unlike many drugs, biologics are not compounds that can be manufactured from chemicals. Rather, they are genetically engineered proteins that must be produced by living organisms. They are given by injection or infusion.

Uses

Currently, biologics for ankylosing spondylitis target one of two proteins, either tumor necrosis factor (TNF) or interleukin-17 (IL-17).

Tumor Necrosis Factor (TNF) Inhibitors

One group of biologics can target what’s known as tumor necrosis factor. If there is too much TNF around, it can cause inflammation in your joints and damage them.

TNF inhibitor drugs approved to treat ankylosing spondylitis include:

• Cimzia (certolizumab pegol)
• Enbrel (etanercept)
• Humira (adalimumab)
• Remicade (infliximab)
• Simponi and Simponi Aria (golimumab)

Interleukin-17 (IL-17) Inhibitors

Another target for biologics is a protein called interleukin-17. This protein is often elevated in people with AS. Biologics that decrease the amount of IL-17 help to reduce inflammation in your joints and body.

Biologics to treat AS in this group include:

• Cosentyx (secukinumab)
• Taltz (ixekizumab)

Biosimilars

Biosimilars are drugs that are very similar in structure and function to a biologic drug and have been approved by the Food and Drug Administration after testing to compare it to the original biologic drug.

For AS, biosimilar agents that work a lot like TNF inhibitors include:

• Inflectra (CT-P13), which is like Remicade
• Amjevita (adalimumab-atto), which is like Humira
  

In addition to their approval for the treatment of ankylosing spondylitis, these biologics are also indicated for a variety of other diseases, including:

• Rheumatoid arthritis
• Psoriatic arthritis 
• Crohn’s disease
• Ulcerative colitis
• Plaque psoriasis
  

Before Taking

If your AS symptoms are not improving with other medications, your doctor may recommend that you begin taking a biologic. Before these are even considered, they may try other treatments such as physical therapy, exercise, and the use of painkillers.

It is only if you are not getting the relief you need from these that they may suggest a biologic. While you may be eager to begin treatment with a potent biologic medication, keep in mind this will not happen immediately.

First, it’s important to undergo some screening to make sure that the biologic class is safe for you. When these drugs tamp down on inflammation, they do so by targeting part of your immune system. This may be a problem if you have an infection that your immune system is keeping under control.

Tuberculosis Testing

You will likely be checked for latent tuberculosis. Sometimes if you have tuberculosis, you may not even realize this because your immune system keeps it under control.

Tests to check for tuberculosis include:

• TB skin test
• Blood test
  
• Chest X-ray (in some cases)

Hepatitis B and C Testing

You will be tested for the hepatitis B virus with blood tests to see if the virus or antibodies to it are present. If you test positive, this may be the result of a past infection or current infection.

Your doctor would then measure virus levels. If these are not too high, the doctor may begin the biologic, but also continue to monitor you for any changes in your liver. If your levels are high, you may be referred to an infectious disease specialist for the treatment of hepatitis B.

Hepatitis C testing is also recommended and is often done with the same blood draw as testing for hepatitis B. You may have hepatitis C and be unaware of it. The risk with hepatitis C is that it can eventually cause liver damage or liver cancer, but the good news is that there are treatments that can curtail this.

If you do have hepatitis C, your doctor may also want to do a liver biopsy, as well as check for any signs of cancer.

Get Baseline Levels

Expect blood tests to include complete blood count, lipid and cholesterol levels, and liver enzymes. Biologics can sometimes affect these, so the doctor needs to know what’s normal for you.

In some cases, biologics can cause blood abnormalities. Knowing your baseline levels, your doctor can tell if they need to perhaps lower the dose or stop the medication altogether. Biologics may also increase triglycerides and levels of LDL “bad” cholesterol.

Finally, biologics can potentially cause liver enzymes to climb. If these are 1.5 to three times the normal range, then you will be closely monitored if you are still given a biologic. Any higher than that may make a biologic unsuitable for you.

Report Other Medications

If your doctor suggests a biologic for you, be sure to tell them about any other medications, vitamins, or supplements that you may be taking. While some drugs pose minor interaction risks, others may outright contraindicate use or prompt careful consideration as to whether the pros of treatment outweigh the cons in your case.

Precautions and Contraindications

While some biologics don’t have any specific contraindications (situations in which the drug may be harmful), others do.

Cimzia, Cosentyx, and Remicade are all contraindicated for anyone with a serious hypersensitivity reaction to the biologic or ingredients in its preparations. Remicade is also contraindicated for some people with moderate-to-severe heart failure.

For all the biologics used for AS, individuals with a variety of conditions must take precautions. Some of the conditions that may hold up or stop the use of biologics include:

• Active infection
• Being treated for cancer, diabetes, a heart condition, or a nervous disorder, which can increase infection risk or chances for an adverse event
• Having undergone a live virus vaccination recently
• Having tuberculosis or hepatitis
• Future surgery is planned, which brings with it concerns about infections
• Allergies
• Being pregnant or breastfeeding
  

Special Populations

People capable of becoming pregnant who are on biologics for their AS should keep in mind that most of these therapies have not been studied in pregnant or breastfeeding populations. It isn’t known whether or not they could be harmful to the fetus or infant.

If you are taking this medication and think you may be pregnant, call your doctor and discuss how this might affect your AS before stopping this medication.

Dosage

Biologics are given by a subcutaneous injection just below the skin or by intravenous infusion in a solution. They may need to be given by a healthcare professional in an office or clinic.

But some agents such as Humira, Enbrel, Simponi, and Cosentyx can be self-administered with the aid of an injection pen device, or in some cases a prefilled syringe.

How often the biologic is administered varies depending on the agent. For example:

• Humira should be given once every two weeks.
• Enbrel requires once or twice weekly dosing.
• Simponi can be used once monthly.
• Remicade generally must be taken every six to eight weeks, but the dosing may vary from person to person.
• Cosentyx is taken weekly for the first four weeks and then monthly thereafter.

How to Take and Store

A biologic meant for self-injection should typically be kept out of the light, in the refrigerator. It should be brought to room temperature before use. Check with your doctor to find out how long to leave it out. Keep in mind that biologics should never be frozen or shaken.

When taking a biologic, wear gloves and use alcohol to sterilize the area first. After the injection, safely dispose of needles in a special container.

Side Effects

Biologics can have a variety of side effects. Some of these can be effectively managed without taking you off the medication, while others may require considering a different treatment approach.

Common

Some side effects are common but can be very effectively managed. Also, side effects are more likely to happen in the first nine months of treatment than to happen later.

One frequent issue is seeing signs of a reaction where you insert the needle. Symptoms can include:

• Redness
• Itchiness
• Swelling

The good news is that this may clear up on its own or may be alleviated by using a cold compress or taking acetaminophen for any pain. If needed, topical corticosteroids or oral antihistamines may also be used.

It’s also not unusual to have an infusion reaction. Keep in mind that your vital signs will be monitored at the clinic where this is given. Before the infusion, you may also be asked to take an anti-inflammatory drug, as well as possibly an antihistamine and medication for nausea.

Otherwise, you might experience mild symptoms of an infusion reaction including:

• Redness at the infusion site
• Swelling
• Pain
• Headache
• Queasiness
• Rash
• Feeling flush

If you start to have a more serious reaction involving chest pain, difficulty breathing, fever, or swelling of the face and hands, the healthcare professional can stop the infusion and promptly treat you.

It’s well known that biologics can make you vulnerable to infection because they tamp down on your immune system. These may be nothing more than a common cold, sinus infection, sore throat, or case of bronchitis. But in other cases, infections may be more serious.

It’s possible that infections you may have been exposed to in the past such as hepatitis B or C or tuberculosis could reactivate. You will, however, be checked to see if you have been exposed to these conditions beforehand.

Severe

It’s also possible that heart issues can be aggravated. Biologics can trigger the start of heart failure. Signs to watch for include:

• Swollen ankles
• Swollen hands
• Shortness of breath

There’s also the potential for you to develop a syndrome that mimics lupus (an autoimmune disease). Alert your doctor if you experience the following:

• A facial rash that gets worse in the sun, or a rash on your arms
• Body pain
• Joint pain in different areas than usual

Be sure to let your doctor know if such signs arise so that they can keep this from becoming a long-term issue.

Warnings and Interactions

While biologics can be very helpful, they also bring with them serious increased risks. The FDA has issued some of its most stringent “black box” warnings about these. Drugs such as Remicade, Enbrel, Humira, and Cimzia bring with them the risk of serious fungal infections that could lead to hospitalization and even death.

Biologics have also been associated with tuberculosis, viral infections, and sepsis (where the body has an extreme reaction to infection). Those on these medications may also be more prone to malignancies.

If you are taking a biologic, be sure to avoid live vaccines. These can include the nasal spray flu vaccine (FluMist), and vaccines for measles, mumps, rubella, shingles, yellow fever, and others. If these are needed, try to get them before starting the biologic.

While FluMist should be avoided, other flu vaccines don’t contain live viruses and can be safely taken. The COVID-19 vaccines are also safe, as they are not live virus vaccines.

Summary

Biologic drugs for ankylosing spondylitis target proteins that are associated with inflammation. These include TNF inhibitors and IL-17 inhibitors. They are administered by infusion or injection.

You will be screened for tuberculosis, hepatitis B, hepatitis C, and active infections before starting these drugs and will be monitored during treatment. Both mild and severe side effects are possible with biologic drugs.