Axial spondyloarthritis and its subtypes

Axial spondyloarthritis* (axSpA) is a chronic inflammatory condition consisting of two subtypes, non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). They have shared symptoms, including spinal pain, reduced mobility, and fatigue.

*(ax-e-yell-spon-dill-o-arth-rye-tiss)

Signs and symptoms of axSpA include:

  • Morning back pain and stiffness
  • Spinal inflammation
  • Pain in lower back and hips
  • Fatigue
  • Reduced physical function
  • Less mobility

What makes AS and nr-axSpA different from back pain?

  • Common back pain is typically caused by injury or overuse and usually goes away after 6 weeks; any longer and it may be something more serious
  • AS and nr-axSpA are types of chronic, inflammatory back pain
  • AS and nr-axSpA occur when the immune system mistakenly attacks healthy joints, mainly in the spine
  • Symptoms may last for 3 months or longer, and can flare on and off
  • Although AS and nr-axSpA are lifelong conditions, there are many ways to manage them

What makes AS different from nr-axSpA?

Both AS and nr-axSpA, subtypes of axial spondyloarthritis (axSpA), are chronic inflammatory rheumatic diseases that primarily affect the spine with some notable differences:

  • With AS, joint damage is clearly visible on an X-ray, but this is not always the case with nr-axSpa
  • The male-to-female ratio of people with AS is 3:1, but with nr-axSpA, the ratio is 1:1
  • While both present differently in everyone, AS tends to impact men in the lower back and buttocks, and impacts women more in the hips, neck, shoulders, and knees
  • With nr-axSpA, women typically have more widespread pain that can lead to a delayed diagnosis compared to men
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How does Taltz work for patients with axial spondyloarthritis?

Taltz is a treatment that targets and blocks interleukin-17A (IL-17A),* which is a protein in your body. Elevated levels of interleukin-17A (IL-17A) are associated with inflammation of the spine and can lead to symptoms of axSpA such as back pain, inflammation, fatigue, and difficulty carrying out daily activities.

*The relationship between how Taltz works and clinical outcomes has not been determined.

Taltz is approved to treat adults with active ankylosing spondylitis (AS) and adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

    PURPOSE AND SAFETY SUMMARY

    Important Facts About Taltz® (tȯl-ts). It is a prescription medicine also known as ixekizumab.

    Taltz is an injectable medicine used to treat:

    • People six years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
    • Adults with active psoriatic arthritis.
    • Adults with active ankylosing spondylitis.
    • Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

    It is not known if Taltz is safe and effective in children for conditions other than plaque psoriasis or in children under 6 years of age.

    WARNINGS

    • Taltz affects the immune system. It may increase your risk of infections, which can be serious. Do not use Taltz if you have any symptoms of infection, unless your doctor tells you to. If you have a symptom after starting Taltz, call your doctor right away.
    • Your doctor should check you for tuberculosis (TB) before you start Taltz, and watch you closely for signs of TB during and after treatment with Taltz.
    • If you have TB, or had it in the past, your doctor may treat you for it before you start Taltz.
    • Do not use Taltz if you have had a serious allergic reaction to ixekizumab or any other ingredient in Taltz, such as: swelling of your eyelids, lips, mouth, tongue or throat, trouble breathing, feeling faint, throat or chest tightness, or skin rash. Get emergency help right away if you have any of these reactions. See the Medication Guide that comes with Taltz for a list of ingredients.
    • Crohn’s disease or ulcerative colitis (inflammatory bowel disease) can start or get worse with Taltz use. Tell your doctor if you have any of these symptoms or if they get worse: stomach pain, diarrhea, and weight loss.
    • You should not get live vaccines while taking Taltz. You should get the vaccines you need before you start Taltz.

    COMMON SIDE EFFECTS

    The most common side effects of Taltz include:

    • Injection site reactions
    • Upper respiratory infections
    • Nausea
    • Fungal skin infections

    Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

    BEFORE USING

    Before you use Taltz, review these questions with your doctor:

    ❑ Are you being treated for an infection?
    ❑ Do you have an infection that does not go away or keeps coming back?
    ❑ Do you have TB or have you been in close contact with someone with TB?
    ❑ Do you have possible symptoms of an infection such as fever, cough, sores, diarrhea, or other symptoms? Ask your doctor about other possible symptoms.
    ❑ Do you have Crohn’s disease or ulcerative colitis?

    Tell your doctor if:

    ❑ You need any vaccines or have had one recently.
    ❑ You take prescription or over-the-counter medicines, vitamins, or herbal supplements.
    ❑ You are pregnant or planning to become pregnant. It is not known if Taltz can harm an unborn baby.
    ❑ You are breastfeeding or planning to breastfeed. It is not known if Taltz passes into breastmilk.

    HOW TO TAKE

    See the instructions for use that come with Taltz. There you will find information about how to store, prepare, and inject Taltz. Adults may self-inject after receiving training from a healthcare provider.

    For people under 18 years of age:

    • Weighing less than 50 kg (i.e., 110 lb): Taltz must be given by a healthcare provider.
    • Weighing more than 50 kg (i.e., 110 lb): If your healthcare provider decides that your caregiver may give your injections of Taltz at home, your caregiver should ask and receive training from a healthcare provider on the right way to prepare and inject Taltz.

    LEARN MORE

    For more information, call 1-800-545-5979 or go to taltz.com .

    This summary provides basic information about Taltz and is not comprehensive. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Taltz and how to take it. Your doctor is the best person to help you decide if Taltz is right for you.
    Taltz® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries and affiliates.

    IX CON BS 29MAY2020