Ankylosing Spondylitis Medications

There are a variety of Ankylosing Spondylitis medications your physician or dermatologists may prescribe. These medications will work differently for each individual. We hope that with this information you will feel comfortable asking your physicians the right questions to help find the right treatment for you:

This information is part of CreakyJoints’ comprehensive guide for patients living with Ankylosing Spondylitis. Learn more or download Raising the Voice of Patients: A Patient’s Guide to Living with Ankylosing Spondylitis.

NSAIDS

Nonsteroidal anti-inflammatory drugs, or NSAIDs, are the most commonly used treatments for Ankylosing Spondylitis inflammation stiffness and pain. While your DMARDs are designed to slow or stop your inflammation at the source in your body’s immune system and, therefore, ease joint swelling and pain, you may also take NSAIDs from time to time as needed for pain. NSAIDs are generally safe to use for minor flares of pain, but they do have many possible side effects if you take them for a long time or in high doses. Side effects include bleeding, damage to the kidneys, gastritis/bleeding ulcers, fluid retention and high blood pressure.

NSAIDS for Ankylosing Spondylitis: What do we already know?

NSAIDs prevent the creation of fatty acids made by your body called prostaglandins. These acids are the products of COX-1 and COX-2 enzymes and play a role in inflammation and pain. Some NSAIDs block both COX-1 and COX-2, although COX-1 also helps keep your stomach acid under control. Meloxicam (Mobic) is an NSAID that blocks Cox -1 and Cox -2 receptors but preferentially blocks Cox-2. Celecoxib (Celebrex®) is an NSAID that only blocks Cox-2 receptors. They may be gentler on your stomach than other NSAIDs.

The ACR believes that most AS patients benefit from treatment with NSAIDs and that the positive consequences far outweigh undesirable consequences for most people. Your doctor may change your NSAID dose depending on how severe your symptoms are. Whether or not your doctor recommends that you use NSAIDs continuously will depend on the severity of your symptoms and how often you have them, other diseases you may have and your personal preferences.

Common NSAIDs you might take for your Ankylosing Spondylitis pain:

  • Aspirin (Bayer ®)
  • Ibuprofen (Advil®, Motrin®)
  • Naproxen sodium (Aleve®)
  • Celecoxib (Celebrex®)
  • Diclofenac sodium (Voltaren®)
  • Indomethacin (Indocin®)
  • Ketoprofen (Actron®, Orudis®)
  • Piroxicam (Feldene®)
  • Meloxicam (Mobic®)

Some NSAIDs are available over the counter, generally at lower doses for mild pain. These include aspirin, ibuprofen and naproxen sodium. You can also buy generic or “store brand” versions of these medicines.

Some NSAIDs are available over the counter, generally at lower doses for mild pain. These include aspirin, ibuprofen and naproxen sodium. You can also buy generic or “store brand” versions of these medicines.For stronger pain, there are higher doses of NSAIDs available by prescription. Some NSAIDs are only available by prescription. Don’t take an over-the-counter NSAID if you’re already taking a prescription NSAID. You could easily take too much medicine and put yourself at high risk for side effects like stomach pain, bleeding, fluid retention or kidney problems.

For stronger pain, there are higher doses of NSAIDs available by prescription. Some NSAIDs are only available by prescription. Don’t take an over-the-counter NSAID if you’re already taking a prescription NSAID. You could easily take too much medicine and put yourself at high risk for side effects like stomach pain, bleeding, fluid retention or kidney problems.

No one NSAID is more effective than others. It’s up to you and your rheumatologist to decide which one may be right for you to take for your arthritis pain. Your rheumatologist will decide which NSAID to prescribe based on your personal history of NSAID use, the potential for side effects and other diseases or conditions you may have.

Why Am I Taking an NSAID?

You may need to take an NSAID for joint pain or stiffness from time to time. Or, your rheumatologist may prescribe a stronger NSAID for your pain if needed. You may not have to take NSAIDs long term. You may just need to take an NSAID on days when your pain feels worse than normal. If you overdo physical activity on certain days and ache afterward, an NSAID may be helpful for relieving your short-term pain.

If you have osteoarthritis (OA) in addition to Ankylosing Spondylitis, you may need to take NSAIDs to help you control your OA pain– which might be caused by a different process in your body.

Some people with Ankylosing Spondylitis control their joint pain, inflammation or stiffness with their DMARDs, biologics or steroids. So you may not need NSAIDs at all or only once in a while. Other people may fi that DMARDs or biologics don’t work well enough to control their pain, and need to take an NSAID too. For others, an NSAID is the only treatment they need. It depends on your body, your day-to-day pain, and how well your other drugs are working to keep your AS under control.

Since taking NSAIDs regularly for pain can cause serious side effects, talk to your rheumatologist about the best way to ease your pain. He or she may suggest that you keep NSAIDs on hand just in case you need them.

Lots of NSAIDs are available over the counter (OTC) in your local drugstore or supermarket, including ibuprofen (Advil®), naproxen sodium (Aleve®) and aspirin. Even these OTC pills can have serious side effects, especially if you take them often. Talk to your rheumatologist about your options for managing your pain. Also, make sure your rheumatologist knows everything you are taking for your pain, even OTC drugs or supplements.

What are the possible side effects of NSAIDs?

NSAIDs can be safe depending on your age and other illnesses that might affect whether you can take NSAIDs. If you have hypertension, diabetes, cardiovascular disease, history of ulcers or any type of kidney problems you may not be able to take even OTC NSAIDs or must be followed very closely by your doctor.

The most common side effect of taking NSAIDs is stomach pain or heartburn. Others include:

  • Bleeding
  • Kidney problems
  • Raised blood pressure
  • Fluid retention
  • Increased risk of heart attack or stroke
  • Ringing in your ears
  • Lightheadedness or dizziness
  • Headaches
  • Allergic reactions, or liver problems (rarely)

If you notice any of these symptoms, get medical care right away:

  • Vomiting
  • Swollen ankles, hands or feet from fluid retention
  • Black or bloody stool
  • Unusual weight gain

Your risk of side effects goes up if you take higher doses of NSAIDs or take these drugs over long periods of time. Also, people who are older or have a history of ulcers may be at higher risk for stomach problems with NSAID use. Talk to your rheumatologist about your options for managing chronic pain.Celecoxib and meloxicam treat arthritis pain as effectively as other NSAIDs, but because they only block COX-2 and not COX-1, they may be easier on your stomach. COX-1 is a prostaglandin that protects the lining of your stomach. So celecoxib and meloxicam may ease your pain and reduce risk of stomach pain or ulcers.

Celecoxib and meloxicam treat arthritis pain as effectively as other NSAIDs, but because they only block COX-2 and not COX-1, they may be easier on your stomach. COX-1 is a prostaglandin that protects the lining of your stomach. So celecoxib and meloxicam may ease your pain and reduce risk of stomach pain or ulcers.

How to monitor for side effects

Let your doctor know if you have unpleasant side effects like heartburn, stomach pain or fluid retention. Don’t “grin and bear it.” It is important to know that many times bleeding ulcers from NSAIDs have no symptoms at all. So it is important to be monitored by your physician for any drop in your red blood cell count or darkening of the color of your stools. Your rheumatologist may be able to lower your dose or suggest another medicine for your pain. Don’t try to treat severe stomach pain or heartburn on your own.

Keep up with all of your regular check-ups so you can track your blood pressure and other vital signs while you take NSAIDs. Taken over a long time, these drugs can raise your risk of serious heart problems. If you already have high blood pressure, it’s important to check your blood pressure often and if it is increased you may need to stop or adjust the dose of the NSAID. Increased blood pressure can damage your kidneys and increase your risk for a heart attack or stroke.

What can I do to help prevent or ease side effects?

If you have side effects from your NSAIDs, such as stomach pain or heartburn, you may be able to add another medicine to lower your stomach acid. There are many drugs called proton pump inhibitors that can reduce your risk of ulcers. They include:

  • omeprazole (Prilosec®, Prilosec® OTC)
  • lansoprazole (Prevacid®, Prevacid® IV, Prevacid® 24-Hour)
  • dexlansoprazole (Dexilent®, Dexilent Solutab®)
  • rabeprazole (Aciphex®, Aciphex® Sprinkle)
  • pantoprazole (Protonix®)
  • esomeprazole (Nexium®, Nexium® IV, Nexium® 24 HR)
  • omeprazole/sodium bicarbonate (Zegerid®, Zegerid® OTC)

Some of these can be purchased over the counter and others you may need a prescription. Some simple ways you may ease NSAIDs’ side effects include:

  • Take the lowest possible dose you need to manage your pain.
  • Take your medicine with food, such as your normal meals or a snack. It should be noted that taking NSAIDs with food will not lower your risk of an ulcer. It may increase the tolerability of the NSAID but it won’t reduce the toxicity.
  • Try coated aspirin instead of uncoated. Please note, this may only increase the tolerability of aspirin and not decrease the risk of an ulcer.
  • Avoid the long-lasting, “once-a-day” NSAIDs, because they stay in your system for a longer time than quick- acting ones.

Consider using acetaminophen (Tylenol®) for occasional joint pain instead of NSAIDs. It has some side effect risks too, so talk to your doctor before you take any OTC drug for arthritis pain.

Discuss with your doctor the synergistic effect of acetaminophen (Tylenol®) with NSAIDs to allow the minimum NSAID dose possible.

Biologics

Biologics are a type of medication produced by living cells. They’re designed to act like the proteins that are already in your body. They target specific areas of your immune system to block them from working. Because they’re so specific, they can cause fewer side effects than DMARDs. Infection is one possible side effect of biologics. Your rheumatologist will watch you closely for any signs that you have an infection. Biologics can be used alone or in combination with methotrexate or another DMARD. Due to their specificity, if one biologic fails, another may work for you. Keep the dialogue open with your doctor in the case that you may need to switch.

TNFi biologics

These biologics work by targeting something called tumor necrosis factor protein, or TNF. TNF is a protein that sends signals to your body, eventually leading to inflammation that causes swelling, pain, and stiffness. By inhibiting, or stopping, TNF, these medications can reduce inflammation. That’s why they’re often called TNF inhibitors (or TNFi).

Some common TNFi biologics are adalimumab (Humira®), certolizumab pegol (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®, Simponi Aria®), and infliximab (Remicade®).

These biologics are molecules that are specially designed to target TNF and block it at the source. They can cool down your immune response that’s out of control in AS in order to ease your AS symptoms. They may have the potential also to protect your joints from damage.

The ACR treatment guidelines strongly recommend using TNFi’s for patients who have a lack of response to at least two NSAIDs, or cannot tolerate NSAIDs due to side effects. The guidelines do not favor any specific TNFi, although they noted that infliximab (Remicade®) or adalimumab (Humira®) would be preferable for Ankylosing Spondylitis patients who also have inflammatory bowel disease or recurrent iritis (inflammation of the colored ring around your eye’s pupil).

Personal considerations such as out-of-pocket cost, comorbidities, and side effects may make TNFi therapy the best option. Make sure you have a talk with your physician about why a certain treatment option is best for you. Treatments like TNFi drugs are very case-specific.

How do I take my TNFi biologic?

You may be able to give yourself this medication, via injections, at home (known as “self-injection”), or via an infusion in the doctor’s office or other infusion site. A healthcare professional will indicate where on your body it is safe to administer these injections (usually the upper leg or stomach). Make sure to rotate the injection sites. If you have psoriasis, do not inject in the affected areas. If you’re afraid to inject yourself, talk to your nurse, clinic staff, or pharmacy about having someone there give you these shots.

Be sure you are confident on how to do this procedure before you inject the medication on your own. Don’t be afraid to ask for help!

You may also get your biologic as an infusion instead of a shot. A healthcare professional gives you the drug through an IV. You’ll get your treatment in your doctor’s office, at a special infusion center, or at your local hospital. You and your doctor can decide if an infusion is the right option for you. The infusions can last as little as 30 minutes, or could take up to several hours — depending on the drug, dose, and individual.

Adalimumab (Humira®) is given as a 40 mg self-administered subcutaneous (under the skin) injection every other week.

Certolizumab pegol (Cimzia®) is given as a subcutaneous injection of 400 mg on weeks 0, 2, and 4, followed by 200 mg every two weeks or 400 mg every four weeks. Cimzia® can also be given in a lyophilized (dehydrated and freeze-dried) formula that is given in the doctor’s office.

Etanercept (Enbrel®) is given as a 50 mg self-administered subcutaneous injection every week or 25 mg self- administered injection twice weekly.

Golimumab (Simponi®) is given as a 50 mg self-administered subcutaneous injection once monthly.

Golimumab (Simponi Aria®) is given via IV infusion in the clinic or infusion center on weeks 0 and 4, followed by IV infusion every eight weeks. Dose is based on weight.

Infliximab (Remicade®) is given via IV infusion in the clinic or infusion center at weeks 0, 2, and 6, then by infusion every four to eight weeks. Dose is based on weight.

The benefits of TNFi medications are usually seen within a few weeks (but can take up to four to six weeks), unlike DMARDs, which can take up to a few months to have their effects.

Side Effects of TNFi Biologics

Side effects of TNFi drugs might include injection site reactions, upper respiratory infections, laboratory abnormalities, and headache. The likelihood of experiencing these and any side effects vary from individual to individual, and should always be discussed with your doctor before beginning treatment.

Infliximab has been associated with the development of antinuclear and anti-double stranded DNA antibodies, nausea, abdominal pain, and infusion reactions. Serious side effects include increased risk of infection, especially tuberculosis and fungal infections. Untreated hepatitis B may worsen while taking TNFi’s. You should be tested for TB and hepatitis before starting one of these medications.

Less common side effects include allergic reaction and development of other immune system disorders. If you have had cancer of any type, or have an increased risk, you will need to discuss the various options with your rheumatologist regarding the use of any biologics.

If you think that you might have an infection, check with your doctor before taking your drug. Biologic drugs make it harder for your body’s immune system to fight off infections. They may even make it harder for you to spot the early signs of infection, so talk to your doctor about what to look for.

For more information, go here.

If you’re planning to have surgery, talk to your rheumatologist first. You may need to go off your biologic for some time before you have the surgery.

TNFi Biologics Contraindications

Live and attenuated live vaccines, such as the shingles vaccine, yellow fever vaccine, and Flumist® (intranasal flu vaccine), should not be given when taking a TNFi biologic. These medications can interact with vaccines and certain foods and medications. Make sure you talk to your doctor about current medications, planned vaccinations, and any diet changes you make (use of vitamins, herbal products).

Adalimumab (Humira®) specifically interacts with blood thinners (i.e. warfarin (Coumadin®).

Existing Conditions and TNFI biologics

  • Congestive Heart Failure (CHF): TNFi biologic therapy is not recommended for patients living with uncontrolled CHF, as it can lead to a worsening of this condition.
  • Previous Serious Infection: TNFi drugs have been found to increase the incidence of pneumonia, tuberculosis (TB), certain fungal diseases, and skin/soft tissue infection. You will be required to be tested for TB before starting any biologic drug.
  • Hepatitis C without Receiving Antiviral Therapy: The ACR recommends that your physician speak with a gastroenterologist and hepatologist to consider the management of these two disease states. TNFi can be carefully administered while managing treatment of hepatitis C.
  • Previously Treated Lymphoproliferative Disorder: TNFi’s may increase your chances of lymphoma. While an increased risk of lymphoma in Ankylosing Spondylitis patients taking TNFi’s compared to a non-AS population has been shown in studies, studies with Ankylosing Spondylitis patients taking these biologics showed a minimal risk of developing lymphoma if at all.

People who have or have had multiple sclerosis (MS) should not take TNFi drugs.

Be sure to tell your doctor if you are: pregnant or breastfeeding and/or have kidney or liver disease, cancer, CHF, blood or bone marrow problems, or any type of infection. Also mention any nervous-system problems such as Guillain-Barré syndrome or multiple sclerosis. They may indicate that you should not be on TNFi biologics.

When starting most biologics, you’ll need to take frequent blood tests to monitor the drug’s effects. Once you’re established on a biologic, however, your tests will become less frequent. Specifically, for TNFi biologics, blood tests will be done to check bone marrow suppression, a low white blood cell count, or effects on the liver.

Other Biologics

Biologics for Ankylosing Spondylitis: What do we already know?

There are other biologics that target the immune system in different ways from TNFi drugs. They interact with different kinds of white blood cells, such as T cells or B cells, in your immune system. They can also block chemicals called cytokines that cause inflammation.

White blood cells and cytokines are made by your immune system to fight off infection. But in Ankylosing Spondylitis, they may be out of control and cause inflammation. So these drugs can suppress specific parts of your immune system, ease inflammation, stop AS’s progress, and ease your symptoms.

What do the recommendations say?

For patients whose Ankylosing Spondylitis remains active despite treatment with a TNFi, the ACR’s recommendation is to use a different TNFi, because there was not enough information at the time of writing the recommendation to support the use of the available non-TNFi biologic drugs. The ACR also felt that there was not enough clinical evidence to support the use of non-TNFi drugs in people with Ankylosing Spondylitis who could not take any TNFi, and instead recommended treatment with the DMARD sulfasalazine before the use of non-TNFi medications. However, the ACR’s recommendations were published before the FDA approved the interleukin-17A inhibitor secukinumab (Cosentyx®) – a non-TNFi biologic for the treatment of Ankylosing Spondylitis. (See below for more information).

Why am I prescribed a biologic?

Your doctor may prescribe a biologic if taking an NSAID by itself or treatment with another biologic was ineffective. Personal considerations such as out-of-pocket cost, comorbidities, and side effects may make a biologic the best option.

A biologic that works differently than TNFi biologics is secukinumab (Cosentyx®)

Secukinumab (Cosentyx®): In January 2016, the FDA approved the interleukin-17A inhibitor secukinumab (Cosentyx®) for the treatment of adults with active AS. It was also approved to treat active psoriatic arthritis, as well as moderate-to-severe plaque psoriasis (January 2015). Secukinumab works by blocking a cytokine known as IL-17A that can cause inflammation. It is the first and only IL-17A inhibitor approved for adult patients with AS and psoriatic arthritis.

While this approval has broadened the treatment options, there has not been much guidance for doctors and patients as to where this drug will fi in the treatment spectrum. Secukinumab’s availability has put renewed focus on what your rheumatologist should do if you fail on your first TNFi. Because there haven’t been any studies to determine whether it is more effective to try another TNFi or switch to secukinumab, there is no official recommendation or guidelines. Your rheumatologist will decide which treatment is best for you based on several factors including your current level of disease activity, any other conditions you may have and severity of your symptoms.

The most common side effects with secukinumab are colds with inflammation of the nose and throat and blocked or runny nose. Other side effects may include:

  • diarrhea,
  • hives,
  • oral herpes,
  • athlete’s foot,
  • tonsillitis,
  • oral thrush,
  • impetigo,
  • inflammatory bowel disease and
  • eye infection or inflammation.

Because secukinumab may increase the risk of infection, it must not be given to patients with serious active infections such as tuberculosis. Secukinumab is given by injection.

How will I take my biologic?

You may be able to give yourself this medication, via injections, at home (known as “self-injection”), or via an infusion in the doctor’s office or other infusion site. A healthcare professional will indicate where on your body it is safe to administer these injections (usually the upper leg or stomach). Make sure to rotate the injection sites. If you have psoriasis, do not inject in affected areas. If you’re afraid to inject yourself, talk to your nurse, clinic staff, or pharmacy about having someone there give you these shots.

Be sure you are confident on how to do this procedure before you inject the medication on your own. Don’t be afraid to ask for help!

You may also get your biologic as an infusion instead of a shot. A healthcare professional gives you the drug through an IV. You’ll get your treatment at a special infusion center, in your doctor’s office, or at your local hospital. You and your doctor can decide if an infusion is the right option for you. The infusions can last as little as 30 minutes or could take up to several hours — depending on the drug, dose, and individual.

Potential Side Effects of Biologics

As with all biologics, the greatest risk while taking these drugs is infection. Notify your doctor immediately if you experience the signs of infection: fever, chills, or nausea.

How to Monitor

You may have to undergo regular blood testing while on a biologic. Blood tests are also used to measure liver and kidney function, as these are the organs that process what goes through your body. Complete blood counts (CBCs) are tests that measure your bone marrow health and immune cells. This is checked when you get your blood drawn while you’re taking these drugs. By monitoring your blood, your medical team is able to ensure that your body can fight infection without causing the pain, stiffness, and swelling of arthritis.

Again, it’s important for you to watch for any signs of infections, like coughs, discomfort when you urinate, or if you have cuts that aren’t healing. If you have any of these signs in between your doctor’s visits, let your doctor know before you take your next biologic dose.

Biologics Contraindications

With all of the biologics there are times when these medications should not be used. Some of these situations

include a history of recurrent life-threatening infection, untreated tuberculosis or other active infection, history of lymphoma (except for rituximab), active MS or active hepatitis B.

Existing Conditions and Biologics

Previously Treated or Untreated Skin Cancer (Non-Melanoma or Melanoma)
These biologics are not contraindicated in this condition, but it’s very important to have careful monitoring by a dermatologist.

Comorbidities

Chronic respiratory conditions, diabetes, heart disease, and stroke. Talk with your doctor if you have any of these comorbidities. In some cases, medications to treat these conditions may interact with your biologics. It is important that your doctor is giving you the proper treatments for your health concerns.

Biosimilars

There’s another new option available to treat Ankylosing Spondylitis: biosimilar drugs. These are very similar copies of the various biologics that are already on the market. You may have seen this term in the news, or even heard your doctor or nurses mention it. Biosimilars are drugs that are made to be very similar to existing biologic drugs like TNF inhibitors.

The difference between biosimilars and generic drugs

Biosimilars are not exactly like generic drugs, which are exactly the same as the original, brand-name drug, but usually cheaper. But because they use already-completed research to be developed, biosimilars are designed to take less time and clinical trial data to approve, and should be cheaper than the original biologic drug. Biosimilars’ names include the original drug’s generic name and a four-letter suffix to distinguish it. Once approved, biosimilars should have registered (®) brand names of their own.

Approved Biosimilars

On April 5th, 2016 the FDA approved Inflectra® / CT-P13, a biosimilar version of the TNF inhibitor infliximab (Remicade®) for all of the diseases that Remicade® is approved to treat, including ankylosing spondylitis and psoriatic arthritis, making it the first biosimilar drug approved to treat Ankylosing Spondylitis. Inflectra® became available to patients in October of last year. This approval was based on a study that showed over a one-year period, Inflectra® was as effective and safe as Remicade® for treating AS. Renflexis®, another infliximab biosimilar, was approved in April of 2017.

The FDA also approved Amjevita® (adalimumab-atto), a biosimilar to Humira® (adalimumab), to treat Ankylosing Spondylitis last year.

Biosimilar development & approval process

More biosimilars to biologics used to treat Ankylosing Spondylitis are in development now. Due to patent exclusivity held by the innovator drug manufacturers, biosimilars may not be immediately available. There are ongoing challenges to patent rights that are currently in the court system to determine when the particular biosimilar will be permitted to be sold.

The Interchangeability of Biosimilars

Biosimilars will be taken in the same way as their reference drug, and have the same possible side effects, contraindications, and monitoring tests. All biosimilars have to meet the same standards of safety and efficacy as any other prescription drug approved by the FDA. But because they cost less to develop and test, they may not be quite as expensive as other biologics. However, biosimilars are not identical to the original drug — they’re just highly similar.

Each state has different laws about how biosimilars may be substituted for their reference biologic when a prescription comes to the pharmacy. If you have any concerns, talk to your doctor about your state’s rules. More than 35 states have passed laws so far that require pharmacies, including mail-order specialty pharmacies, to notify doctors if they plan to substitute a biosimilar for the reference biologic. Physician associations, pharmacists’ groups, the FDA, pharmaceutical companies, and others are still debating these issues.

In the future, there are expected to be biosimilars that are so close to their reference biologics that the FDA will designate them as interchangeable. There are no interchangeable drugs in development yet, and the FDA has not even established the criteria for designating a drug as “interchangeable.”

When and if a drug is given the interchangeable tag in the future, pharmacists may be able to substitute that drug for the original reference biologic when they fill a prescription from a rheumatologist.

RAISE YOUR VOICE: Biosimilars for Ankylosing Spondylitis are being approved by the FDA now, and more are on the way soon. These drugs will offer you more options to treat your Ankylosing Spondylitis, control inflammation, and ease symptoms. The first step to take is to ask your rheumatologist if there’s a biosimilar available that’s right for you. Start a conversation with your doctor about biosimilars to your current Ankylosing Spondylitis biologic drug, and what potential risks, benefits, or savings you may have if you switch. Call your insurance company to find out if a biosimilar to your current Ankylosing Spondylitis biologic is on their formulary, and how much the biosimilar may cost for you. Information is power. You deserve clear, simple information — including side effects, risks, benefits, and out-of-pocket costs — for all your treatment options. Once approved by the FDA, biosimilars’ manufacturers will also have websites that tell you more about these treatments and patient assistance programs, which may offer you discounts and savings.

Disease-Modifying Anti-Rheumatic Drug (DMARD) Therapy

What is a DMARD?

DMARD is short for disease-modifying anti-rheumatic drugs. While these drugs are frequently prescribed for rheumatoid arthritis, DMARDs are only recommended for Ankylosing Spondylitis patients if there is “peripheral involvement,” meaning you have pain and inflammation in your knees, ankles, arms or hips, and NSAIDs have not worked for you. There is no evidence that DMARDs will help with Ankylosing Spondylitis symptoms in the spine and neck.

The most commonly used DMARDs for Ankylosing Spondylitis are methotrexate (Rheumatrex®, Trexall®) and sulfasalazine (Azulfidine®). It should be noted that the ACR does not recommend the use of DMARDs in the treatment of Ankylosing Spondylitis with the exception of sulfasalazine, which it says can be considered for patients who cannot take a TNF inhibitor (see Biologics section) due to side effects or other factors, or for people with AS who have prominent arthritis that affects the arms and legs.

Methotrexate (Trexall®, Rheumatrex®, Otrexup®, Rasuvo®)

Methotrexate for Ankylosing Spondylitis: What do we already know?

Methotrexate (Trexall®, Rheumatrex®, Otrexup®, Rasuvo®) works by blocking enzymes that help DNA (genetic material in the cells of your body) form or repair. This prevents some cells in your body from reproducing themselves. Experts believe that methotrexate also interacts with your immune system. It is not entirely clear how methotrexate works in Ankylosing Spondylitis, but it can be effective in reducing swelling, pain, and long-term damage to joint in the knees, ankles arms or hips.

Methotrexate is given once a week as either a pill or shot. Some people have better results with the shot, as the medicine is absorbed differently this way and is better tolerated by people who may have experienced an upset stomach when taking the pill form. Use of methotrexate is contraindicated in pregnancy.

What are the possible side effects of methotrexate?

It’s important to remember that most patients do not experience serious side effects from methotrexate, and for those who do have them, they may improve with time. Side effects are more likely to occur at higher doses and you should always consult your doctor if you think you’re experiencing any of these side effects:

  • Gastrointestinal problems, such as nausea, stomach upset, and loose stool
  • Mouth ulcers
  • Hair loss
  • Abnormal liver function blood tests
  • Abnormal blood counts
    • Rare side effects of methotrexate include liver cirrhosis or scarring. This usually happens with patients who already have liver problems or are taking more drugs that impact the liver. Lung problems also occur rarely, and typically only with patients who already have lung issues. Report any difficulty breathing or a cough that won’t go away to your doctor. Take these side effects very seriously.
  • People with liver disease may not be able to take methotrexate or require closer monitoring or lower dosing.
  • Increased skin sensitivity to the sun can also occur, but may stop when the medication is stopped. Supplements like folic acid may help you manage these side effects. If regular folic acid doesn’t help, you may try another type called methylated folic acid. Talk to your doctor about getting methylated folic acid if you still get mouth ulcers, hair loss, or just a “yucky feeling” from your methotrexate. Vitamin A and dextromethorphan (the DM in Robitussin DM) can also be used to help with those side effects.
  • Do not get pregnant while taking methotrexate. For women, recommendations vary from 1 month to 3 months as to how long you should be off methotrexate before getting pregnant. The package insert recommends male patients be off methotrexate for 3 months.
  • Certain antibiotics such as “sulfa” drugs (i.e. Bactrim) should not be taken with methotrexate. Check with your physician before taking an antibiotic with your methotrexate.

Sulfasalazine (Azulfidine®)

Sulfasalazine (Azulfidine®) may be used to treat Ankylosing Spondylitis symptoms like pain or swelling in the arms, knees, hips or ankles. It may be used alone or in combination with other medicines.

Sulfasalazine for Ankylosing Spondylitis: What do we already know?

Sulfasalazine (Azulfidine®) is part of a class of medicines called sulfa drugs. It’s a mix of salicylate, which is the main ingredient in aspirin, and an antibiotic. Some people are allergic to all sulfa drugs, so they can’t take sulfasalazine (Azulfidine®).

Sulfasalazine(Azulfidine®) is sometimes given to Ankylosing Spondylitis patients whose Ankylosing Spondylitis remains active despite the use of NSAIDs. However, for most of these patients, the ACR’s Ankylosing Spondylitis treatment recommendations recommend against the use of sulfasalazine (Azulfidine®). In patients whose Ankylosing Spondylitis is not adequately controlled by NSAIDs, the ACR recommends treatment with a TNFi instead of sulfasalazine (Azulfidine®) The ACR says treatment with sulfasalazine (Azulfidine®) could be considered for patients who cannot take a TNFi due to side effects of other factors. Sulfasalazine (Azulfidine®) could also be considered for people with Ankylosing Spondylitis who also have prominent arthritis that affects the arms and legs (called peripheral arthritis).

We don’t know exactly why sulfasalazine (Azulfidine®) eases symptoms like peripheral pain, swelling, or joint stiffness in some Ankylosing Spondylitis patients. It may prevent joint damage and over the long term, loss of your joint function.

How do I take sulfasalazine?

The typical dose is two 500 mg tablets of sulfasalazine (Azulfidine®) twice per day. Some people may start with a lower dose, such as one or two tablets per day, then build up to the normal dose. Some people may need six 500 mg tablets per day.

You should take your sulfasalazine (Azulfidine®) with food and a full glass of water to help ease stomach side effects. You shouldn’t crush or chew up your sulfasalazine (Azulfidine®) tablets.

Sulfasalazine (Azulfidine®) should be safe to take during pregnancy but, as always, you should check with your physician if you are planning a pregnancy. It may be necessary to take extra folic acid if you continue on sulfasalazine during pregnancy. However, using it during breastfeeding may cause a serious type of jaundice in babies.

If you have an infection, your doctor may have you stop taking sulfasalazine (Azulfidine®).

What are the side effects of sulfasalazine (Azulfidine®)?

Most people have few side effects with sulfasalazine (Azulfidine®). The most common ones are nausea, stomach upset, and headache. Usually, this gets better over time. You can take a coated sulfasalazine (Azulfidine®) pill that may be easier to digest.

Rarer side effects include:

  • headache,
  • skin rashes,
  • itching,
  • mouth sores,
  • liver- or lung problems.

If you get a severe rash, tell your doctor.

Glucocorticoids

What are Glucocorticoids?

Glucocorticoids are medicines used to reduce inflammation. They may also be called corticosteroids or even “steroids” for short. The most commonly prescribed glucocorticoids are prednisone and methylprednisolone (Medrol®), which are taken orally. Corticosteroids may also be injected by your physician directly into the affected joint(s).

What do we already know about Glucocorticoids for Ankylosing Spondylitis?

These strong inflammation-fighting drugs are similar to the cortisone made by your body. Glucocorticoids are designed to act the same way as the hormones (natural steroids) made by your adrenal glands that sit on top of your kidneys. They can suppress inflammation and make your immune system less active. However, increasing the dosage of oral corticosteroids to more than six mg per day can also raise the likelihood of side effects.

The ACR guidelines for the treatment of Ankylosing Spondylitis concluded that there is little evidence to support long- term treatment with systemic (oral) corticosteroids. Short-term treatment with rapid tapering off of a corticosteroid may be used in a very limited number of circumstances. More commonly, corticosteroids are injected directly into a joint to quickly relieve pain and swelling if you are having a flare in just one or two joints, or if your symptoms are not relieved by taking an NSAID.

Why am I taking a glucocorticoid?

More than likely, you are taking glucocorticoids short term to help treat joint pain and swelling. Because steroids have side effects, if you’re prescribed oral corticosteroids it’s best to take the lowest possible dose you need to ease your symptoms. You should never suddenly stop your steroids if you have been taking them for longer than two weeks, unless you have tapered to a low enough dose as directed by your doctor.

Corticosteroid injections work quickly but the results are temporary. Your doctor can inject corticosteroids in your sacroiliac joint (where your lower back meets your pelvis), knee, or hip joints. However, injections should not be used as your main Ankylosing Spondylitis treatment. The ACR does not recommend injecting corticosteroids around tendons due to the risk of tendon rupture.

What are the possible side effects of glucocorticoids?

  • Increased infection risk
  • Diabetes
  • Hypertension
  • High blood pressure
  • Weight gain
  • Osteopenia and osteoporosis (thinning or weakened bones)
  • Glaucoma or cataracts in your eyes
  • Acne
  • Roundness of the face or “moon face”
  • Nervousness and inability to sleep (particularly if you take it at night)

Your chances of having these side effects depend on your dose, how long you take glucocorticoids, or if you have other medical conditions.

How to Monitor Glucocorticoids

You and your doctor should be on the lookout for any of the above side effects. If you have these, you may need to adjust your steroid dose. If you have diabetes you will need to check your blood sugar more often and may have to adjust your medication, as steroids can increase your blood sugar. Your doctor will review your use of glucocorticoids often. You probably won’t need to keep taking these drugs for very long.

How can I reduce the side effects of glucocorticoids?

Here are some steps you can take to lower your risk of side effects from glucocorticoids:

  • Increase your calcium and vitamin D intake, and do weight-bearing exercises to protect your bones. You may need to take a medicine to protect your bones if you remain on steroids for a long time.
  • Eat plenty of green, leafy veggies, and lower your intake of sugar and salt to prevent weight gain, diabetes risk, and high blood pressure.
  • Cut back on or quit smoking and drinking alcohol to boost your bone and heart health.

Vaccines and Ankylosing Spondylitis

If you have Ankylosing Spondylitis, you may have a greater risk for getting an infection like the flu, pneumonia or shingles. Why the high risk? The drugs you take that lower your immune system’s activity take a toll on your body’s ability to fight off infection.

Of course, there are vaccines that help protect you from these infections. Generally, the recommendation is for people with Ankylosing Spondylitis to receive an annual influenza vaccine, the shingles vaccine (given one time) and the pneumonia vaccine (given every five to 10 years). However, if you are taking certain medications, there may be some risks with vaccines. So you need to work with your rheumatologist to make sure that you get vaccinated safely, or find ways to help protect yourself from infection if it’s not safe for you to get vaccines. It’s an important conversation for everyone to have with their doctor, but it’s especially important for people with autoimmune conditions such Ankylosing Spondylitis.

Why are vaccines risky for Ankylosing Spondylitis patients?

Some common vaccines use versions of the viruses that cause the infection. These are often called “live vaccines.” The vaccine works by tricking your immune system into thinking it’s the infection, and then your immune system protects you from the viruses in the future – making you “immune.”

But if you’re taking a DMARD, a biologic drug, or a glucocorticoid, your treatments could make your immune system more vulnerable. It may not be able to handle a live or even a weakened version of these viruses. You could get very sick from the treatment that’s meant to protect you.

It is possible to get some vaccines if you’re using DMARDs, steroids or biologic drugs. Work with your rheumatologist to create a plan for your necessary vaccinations. You may need to get vaccinated before you start your Ankylosing Spondylitis drugs.

Avoid live vaccines if you are on a biologic

Some examples of live vaccines are:

  • the measles, mumps and rubella vaccine,
  • the shingles vaccine,
  • the chicken pox vaccine.

There is a nasal form of the flu vaccine known Flumist® which is a live vaccine but the injectable flu shots are not live and able to be taken by those on a biologic. If you will be traveling it is helpful to know that the Yellow Fever vaccine is also a live virus and should be avoided by those on a biologic.

ACR Vaccine Recommendations

While the ACR has not released vaccine recommendations specific to Ankylosing Spondylitis, the ACR recommendations for people with Rheumatoid Arthritis (see below) would apply to anyone with Ankylosing Spondylitis taking a DMARD or biologic.

In 2012, the ACR offered vaccine recommendations for people with Rheumatoid Arthritis who are either starting or currently use DMARDs and biologics. They recommended, based on your age and risk for getting these infectious diseases, that you could get these killed vaccines while you’re on DMARD or biologic therapy: pneumococcal, intramuscular influenza (flu shot) and hepatitis B virus. They also recommended that, based on your age and risk, that you get the recombinant vaccine for human papillomavirus (HPV) vaccine, Gardasil®. The HPV vaccine is recommended for all people younger than 26. It can help protect you from an infection that can cause different types of cancer.

What about the shingles vaccine? Caused by the virus herpes zoster, shingles is a painful skin disease. It can also put you at risk for other health problems. The herpes zoster vaccine is a live vaccine, so the ACR recommended that people with Rheumatoid Arthritis who are already taking biologics not get this vaccine while on therapy.

If you have an autoimmune/autoinflammatory rheumatic disease like Ankylosing Spondylitis, you may be at higher risk for getting shingles, so the vaccine may help you prevent it. As of now, however, you would need to stop the biologic for a certain amount of time before or after receiving the shingles vaccine. The exact amount of time would depend on the type of biologic that you are taking. This is a discussion to have with your rheumatologist to determine if this is right for you. Because there’s still a lot to learn about the risk, more studies and trials are going on now to test the herpes zoster vaccine’s safety if you’re on biologics.

The bottom line about vaccinations:

Talk to your rheumatologist. Don’t get any vaccines, even flu or shingles shots, at your local pharmacy without letting your rheumatologist know. You and your rheumatologist can plan to vaccinate you safely, or to watch for signs of infections if it’s not safe for you to get vaccinated right now.

You can take other steps to help prevent infections if you’re on a biologic:

  • Avoid friends or family members who are sick with the flu or pneumonia. Excuse yourself from visiting sick people because it could put you at risk. Call, text or email them instead if you want to check on them.
  • Wash your hands, especially if you’re in public places like the mall, school or college, office buildings or restaurants and after you use hand rails, push elevator buttons, or open doors.
  • If you notice that a lot of people at work are getting sick with the flu or even coughing, ask your supervisor if you can telecommute for a few days.
  • Watch for any signs of infection, like fever, chills or rash. Let your doctor know right away if you think you have an infection, so you can get treatment promptly.

Free Download: Patient Guidelines for Ankylosing Spondylitis.

Download CreakyJoints’ comprehensive guide for patients living with ankylosing spondylitis. Fill out the form below or click here to learn more.