Actemra：FDA批准的多种自身免疫性疾病治疗方法

Various autoimmune diseases, such as rheumatoid arthritis (RA), can make life challenging.  Most autoimmune diseases cause pain and make it difficult to perform daily tasks. Fortunately, modern medicine has given us several treatment options to help manage these conditions. Actemra is one of the treatment options to treat various autoimmune and inflammatory diseases.  

You may be wondering what Actemra is, how it works, and what the side effects are. In this article, we will break down everything you need to know about Actemra.

What Is Actemra?

Actemra (tocilizumab) is a prescription drug used to treat several autoimmune and inflammatory diseases. These diseases include rheumatoid arthritis (RA), giant cell arteritis, a type of lung disease, certain types of arthritis in children, and COVID-19. Actemra is also used to manage cytokine release syndrome, a severe reaction to certain cancer treatments. 

Actemra was developed by Genentech, and the FDA first approved it on January 8, 2010 [1]. It belongs to a class of drugs known as interleukin-6 (IL-6) receptor antagonists, and it works by blocking a protein in the body called IL-6, which causes inflammation in autoimmune diseases [2].

Like all medications, Actemra can also cause side effects. Therefore, discussing the risks and benefits of the treatment with your provider is crucial.

What Is Actemra Used To Treat?

Actemra is FDA-approved to treat the following conditions [2]:

Rheumatoid Arthritis (RA): RA is a long-term inflammatory disease that primarily affects the joints. It causes symptoms like joint pain, swelling, and stiffness. Actemra is used to treat moderate to severe rheumatoid arthritis in adults who have not responded well to other treatments.

Giant Cell Arteritis (GCA): This is an inflammatory disease that affects the large blood vessels in the head. Actemra is used to treat GCA. It can help reduce inflammation and prevent complications like vision loss.

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): This is a rare and severe condition where the lungs get scarred, making it hard to breathe. Actemra is used to slow the progression of this lung disease.

Polyarticular Juvenile Idiopathic Arthritis (PJIA): This is a type of arthritis that affects five or more joints in children. Actemra is indicated to treat children aged 2 years or older with PJIA.

Systemic Juvenile Idiopathic Arthritis (SJIA): SJIA is a severe form of juvenile arthritis that causes inflammation in one or more joints and affects internal organs. Actemra is indicated to treat children aged 2 years or older with SJIA.

Cytokine Release Syndrome (CRS): CRS is a serious and life-threatening reaction caused by certain cancer treatments like CAR T-cell therapy. Actemra is used to treat adults and children aged 2 years or older with CRS. It can manage CRS by reducing inflammation.

COVID-19: Actemra was granted emergency use authorization by the FDA for treating hospitalized adults with severe COVID-19. It is used for COVID-19 patients who are already taking corticosteroids and need oxygen support.

How Does Actemra Work?

In autoimmune diseases such as rheumatoid arthritis, your immune system becomes overactive and mistakenly attacks your own body. This action causes inflammation and pain, especially in the joints. This happens because a protein in your body called interleukin-6 (IL-6) signals your immune system to create inflammation.

Actemra works by blocking the IL-6 protein from attaching to its receptor on the surface of cells [2]. By doing this, Actemra reduces the inflammation that causes the symptoms of various autoimmune and inflammatory diseases. 

副作用

Like all medications, Actemra can cause side effects. Below are some of the side effects of Actemra [3]:

常见副作用

Here are some of the most common side effects:

• 高血压
• 头痛
• Injection site reactions (such as pain, redness, or swelling)
• Upper respiratory tract infections (like common colds or sinus infections)

These common side effects usually subside quickly.  However, please consult your provider if they worsen or do not go away. 

严重的副作用

In rare cases, Actemra can cause serious side effects. If you experience any of these serious side effects, seek immediate medical attention. Here are some of the serious side effects of this medication:

Serious Infections: Actemra can increase your chance of serious infections, including tuberculosis (TB) and infections caused by viruses, bacteria, or fungi.

Liver Problems: Actemra can cause severe liver problems. Symptoms include dark urine, yellowing of the skin or eyes, or severe fatigue.

Gastrointestinal Tears (Perforations): Actemra can increase the risk of tears forming in your stomach or intestines. This can cause symptoms like stomach pain, fever, or changes in bowel habits.

Serious Allergic Reactions: Actemra can cause serious allergic reactions, including death. You may experience symptoms like rash, difficulty breathing, chest pain, swelling of the face, lips, or tongue.

Note: This is not a list of all possible side effects. Seek immediate medical attention if you experience any severe side effects.

剂量信息

The following information describes the recommended doses of Actemra [2]. However, be sure to follow the specific dosing instructions given by your provider because treatment with Actemra is dose-specific for each patient.  

For Rheumatoid Arthritis: You can get this medication via subcutaneous injection. If your weight is less than 100 kg, the usual dosage is 162 mg every other week, followed by an increase every week based on clinical response. If your weight is more than 100 kg, the usual dose is 162 mg every week.

For Giant Cell Arteritis: The recommended dose is 6 mg/kg administered through an intravenous (IV) infusion every 4 weeks in combination with a 

tapering course of glucocorticoids.

For Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Actemra is recommended for adult patients with SSc-ILD at a weekly dose of 162 mg, administered subcutaneously. 

For Polyarticular Juvenile Idiopathic Arthritis (PJIA): The subcutaneous PJIA dosage for a child less than 30 kg weight is 162 mg once every 3 weeks. The dosage for a child at or above 30 kg weight is 162 mg once every 2 weeks.

For Systemic Juvenile Idiopathic Arthritis (SJIA): The subcutaneous SJIA dosage for a child less than 30 kg weight is 162 mg once every 2 weeks. The dosage for a child at or above 30 kg weight is 162 mg once every week.

For Cytokine Release Syndrome (CRS): When used for CRS, Actemra is typically administered intravenously. For patients less than 30 kg in weight, the recommended dose is 12 mg/kg in body weight. For patients at or above 30 kg weight, the recommended dose is 8 mg/kg.

For COVID-19: Actemra is recommended for adult COVID-19 patients at a dosage of 8 mg per kg, delivered via intravenous infusion over 60 minutes. 

成本

The price of Actemra’s intravenous solution (20 mg/ml) is approximately $569 for a supply of 4 ml. The price of the subcutaneous solution (162 mg/0.9 ml) is about $1,247 for a supply of 0.9 ml [4]. However, the real cost will depend on your insurance plan and location. You can apply for the Actemra Copay Program. If you are eligible, you could receive copay assistance up to $15,000 per year [5].

常见问题解答

Here are some frequently asked questions:

1. Can I use this medication during pregnancy or breastfeeding?

Based on animal studies, researchers have found that Actemra can cause harm to the fetus [2]. Please consult with your provider if you want to use Actemra during pregnancy or if you are breastfeeding. 

2. Can I receive vaccinations while on Actemra?

The clinical safety of live vaccines is still unknown [2]. It is suggested that you should not receive vaccinations while on this medication. Experts suggest that you should be brought up to date on all vaccinations before starting Actemra treatment.

3. Can Actemra interact with other medications?

Yes, it can interact with other medications [2]. So, it is important that you inform your doctor about all the medications, supplements, and over-the-counter products you are using.