Cosentyx® (secukinumab)

On June 17, 2020, the FDA approved Cosentyx (secukinumab) for treatment of nonradiographic axial spondyloarthritis (nr-axSpA). It is meant for adults with signs of inflammation, such as high CRP levels or joint inflammation visible on MRI.1 Cosentyx is the third biologic approved to treat nr-AxSpA.

Cosentyx works by blocking a protein that promotes inflammation. It is also approved to treat plaque psoriasis, psoriatic arthritis, and ankylosing spondyloarthritis.1

Side effects are similar for people with all conditions. This provides more information for you and your doctor to make better decisions about using Cosentyx.1

How does Cosentyx work?

Axial spondyloarthritis affects the joints of the lower back and spine. The hallmark symptoms are chronic inflammatory back pain and fatigue. One protein that promotes inflammation is called interleukin 17A (IL-17A). IL-17A binds to another protein on our cells and causes them to release proteins called chemokines.1

Chemokines attract immune cells to the area of inflammation. This helps us heal wounds and fight infections. But chronic joint inflammation can lead to the severe pain experienced by people with nr-axSpA and other inflammatory disorders.1

Secukinumab, which is the active ingredient of Cosentyx, is an antibody designed to bind to IL-17A. Once IL-17A is bound, it cannot cause cells to release chemokines. This helps reduce inflammation and relieve nr-axSpA symptoms.2

After 16 weeks of treatment with Cosentyx, many people experience pain relief and improved quality of life.2

How was Cosentyx studied?

A phase 3 clinical trial assessed the success of Cosentyx to treat people with nr-axSpA. Every 4 weeks, 555 adults received either Cosentyx or placebo. All participants were adults with signs of inflammation, no radiographic evidence of joint damage, and no relief using NSAIDs.2

The trial evaluated all participants for a 40 percent improvement in nr-axSpA symptoms. More people treated with Cosentyx achieved this goal after weeks 16 and 52 of treatment. Cosentyx also improved participants’ quality of life and health status after 16 and 52 weeks of treatment. People with nr-axSpA showed similar safety risks as those treated for other conditions.2

What are the side effects of Cosentyx?

The most common side effects of Cosentyx are cold symptoms, diarrhea, and upper respiratory infections.2

Cosentyx changes the way your immune system works. This may reduce your body’s ability to fight infections. Before beginning treatment, your doctor should test you for tuberculosis (TB). You should also be monitored for TB during and after treatment. Contact your doctor if you show symptoms of infection, such as:3

  • Fever, sweats, or chills
  • Muscle aches
  • Cough
  • Shortness of breath
  • Blood in your phlegm
  • Diarrhea or stomach pain
  • Weight loss

Some people have allergic reactions to secukinumab or the other ingredients in Cosentyx. People with latex allergies should use Cosentyx cautiously because the removal cap contains latex. Get emergency help immediately if you show symptoms of a serious allergic reaction, including:3

  • Feeling faint
  • Swollen face, mouth, tongue, or throat
  • Trouble breathing or throat tightness
  • Chest tightness
  • Skin rash

Cosentyx may increase the risk of inflammatory bowel disease (IBD). Contact your doctor if you show worsening symptoms of IBD or develop new symptoms of stomach pain or diarrhea.3

These are not all possible side effects of Cosentyx. Call your doctor for medical advice about any bothersome side effects.

What else should I know about Cosentyx?

Use Cosentyx as prescribed by your doctor. Do not take Cosentyx if you have had an allergic reaction to secukinumab or any ingredients of Cosentyx.

Cosentyx is given as an injection using a single-use pen or a pre-filled syringe into the upper arms, thighs, or abdomen. Your doctor may train you or your caregiver to give your injections at home. Do not inject an area of skin that is tender, bruised, or red. Each dose should be injected at a different spot than the last dose. This will help prevent skin reactions.3

Before starting treatment, tell your doctor if you:3

  • Are being treated for an infection
  • Have an infection that does not go away or keeps coming back
  • Have TB or have been in close contact with someone with TB
  • Are allergic to latex
  • Have IBD
  • Have recently received or are scheduled to receive a vaccine
  • Are pregnant or planning to become pregnant
  • Are breastfeeding or planning to breastfeed
  • Take any medications

Talk to your doctor for more specific information regarding treatment for your situation.

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