Last updated: June 2020
On June 1, 2020, the FDA approved Taltz (ixekizumab) to treat adults with nonradiographic axial spondyloarthritis (nr-axSpA). It is meant for people with signs of inflammation, such as high CRP levels or joint inflammation visible on MRI.1
Taltz relieves symptoms by blocking a protein involved in inflammation. It has already been approved to treat plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.1
Over 100,000 people worldwide have already been treated with Taltz. Side effects are similar across all conditions being treated. This helps you and your doctor to make more informed decisions about using Taltz.2
How does Taltz work?
Axial spondyloarthritis affects lower back joints and the spine. It results in chronic inflammatory back pain and fatigue. One protein involved in this inflammation is called interleukin 17A (IL-17A). IL-17A binds to the surface of our cells and causes cells to release proteins called chemokines.2
These chemokines recruit immune cells to the site of inflammation. This process is important for healing wounds and eliminating infections. But chronic inflammation leads to the symptoms of nr-axSpA and other inflammatory disorders.2
The active ingredient of Taltz, ixekizumab, is a protein designed to bind to IL-17A. Once ixekizumab binds IL-17A, it cannot attach to the surface of our cells. This reduces inflammation and controls nr-axSpA symptoms.3
How was Taltz studied?
A phase 3 clinical trial evaluated the ability of Taltz to treat people with nr-axSpA. Every 4 weeks, 96 people received Taltz and 105 people received a placebo. All participants were adults who had signs of inflammation, no radiographic evidence of joint damage, and no relief using NSAIDs.1,3
All participants were evaluated for a 40 percent improvement in nr-axSpA symptoms. After 16 and 52 weeks of treatment, more people treated with Taltz achieved this goal than people treated with placebo.3
People treated with Taltz also showed improved physical functioning, energy, and social functioning. The observed safety risks were similar to when treating other conditions.3
What are the side effects of Taltz?
The most common side effects of Taltz are injection site reactions, upper respiratory infections, nausea, and fungal infections.
Taltz affects your immune system and may lower your ability to fight infections. Your doctor should check you for tuberculosis (TB) before starting treatment. They should monitor you for TB during and after treatment. Call your doctor if you have any symptoms of infections, including:5
- Fever, sweats, or chills
- Muscle aches
- Cough or shortness of breath
- Warm, red, or painful skin or sores
- Diarrhea or stomach pain
Some people experience allergic reactions to Taltz. Stop taking Taltz and get emergency help if you have any symptoms of a serious allergic reaction, such as:5
- Feeling faint
- Swollen face, lips, mouth, tongue, or throat
- Trouble breathing or throat tightness
- Chest tightness
- Skin rash
Taltz may increase the risk of inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis. Call your doctor if you have new or worsening symptoms of IBD, such as:5
- Stomach pain
- Diarrhea with or without blood
- Weight loss
These are not all possible side effects of Taltz. Call your doctor if you have any side effect that bothers you.
What else should I know about Taltz?
Use Taltz exactly as prescribed by your doctor. Do not use Taltz if you have had an allergic reaction to ixekizumab or other ingredients of Taltz.
Taltz is given as an injection with an auto-injector or a pre-filled syringe into the upper arms, thighs, or abdomen. You or your caregiver may give your injections at home after being trained by your doctor. You should inject each dose at a different place than the previous dose. This will help reduce skin reactions around the injection site.5
Store Taltz away from light and in the refrigerator. And do not freeze or shake Taltz. If you miss a dose, take a dose as soon as possible. Then take your next dose at the regular scheduled time. If you inject too much, call your doctor or go the ER.5
Before starting treatment with Taltz, it is good to tell your doctor if you:
- Are being treated for an infection or have an infection that does not go away
- Have TB or have been in close contact with someone with TB
- Have Crohn’s disease or ulcerative colitis
- 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
Your doctor can give more specific information and advice regarding treatment for your needs.