Dermatomyositis (DM) is a rare autoimmune disease. “Autoimmune” means the body’s immune system, which normally fights infections, mistakenly attacks its own healthy tissues. In dermatomyositis, the immune system targets the skin and muscles, causing two main types of symptoms:
- Skin rashes, which include a reddish or purplish discoloration around the eyes (called a heliotrope rash) and scaly bumps over the knuckles, elbows, or knees
- Muscle weakness, especially in the muscles closest to the trunk of the body, such as the shoulders, upper arms, hips, and thighs, which can make it hard to do daily activities such as climbing stairs, lifting objects, or getting up from a chair
Dermatomyositis can also affect other parts of the body, such as the lungs, joints, blood vessels, and digestive tract. Symptoms can be mild or severe, and they may come and go over time.
There is no cure for dermatomyositis, but treatment can help manage symptoms, reduce inflammation, and improve quality of life. Corticosteroids (such as prednisone) are often used first because they can work quickly. However, they can cause serious side effects when used for a long time. Other medicines that suppress the immune system (such as methotrexate, azathioprine, or mycophenolate mofetil) may be added early to help lower corticosteroid use and manage symptoms over time. If these treatments do not work well enough or cause too many side effects, your health care provider may recommend a different treatment option, such as IV immunoglobulin.
Octagam is a brand of IV immunoglobulin, or IVIG for short. IVIG is a purified solution of antibodies, specifically immunoglobulin G (IgG), collected from the blood of healthy donors. It is given as an infusion into a vein (intravenously) by a health care provider.
Below are common questions and answers about how Octagam works for dermatomyositis and what to expect from treatment.
How Does Octagam Work for Dermatomyositis?
The exact way Octagam works for dermatomyositis is not completely understood. It is thought to calm an overactive immune system in many ways:
- It may block part of the immune system called the complement system, which contributes to the damage of tiny blood vessels in the muscles and skin.
- It may reduce the levels of inflammatory chemicals called cytokines.
- It may interfere with the activity of immune cells that are attacking the body’s own tissues.
Octagam does not broadly suppress the entire immune system the way some other medicines do. Instead, it seems to adjust the immune response to reduce the specific type of inflammation seen in dermatomyositis.
Octagam 10% is FDA-approved for the treatment of dermatomyositis in adults. It is the first IVIG medicine that has received this specific approval, based on the results of a large clinical trial described below.
How Was Octagam Studied for Dermatomyositis?
Octagam was studied for dermatomyositis in a clinical trial called ProDERM. The study included adults with active dermatomyositis. “Active” dermatomyositis means the disease was causing symptoms or signs of inflammation at the time of the study.
Here are some details about the 95 adults who took part in the study:
- The median (middle) age was 52 years (ranging from 22 to 79).
- Most (75%) participants were female, and the rest were male.
- Most participants were White (92%), 5% were Black, 2% were Asian, and 1% were of other races; 5% identified as Hispanic/Latino, and 95% identified as not Hispanic/Latino.
- Many people in the study were already taking other medicines for their dermatomyositis, such as corticosteroids (88%), immunosuppressants (68%), or both. People who were already taking these medicines had to be on stable doses before joining the study.
Certain treatments were not allowed, including biologic medicines, cyclophosphamide, other IVIG products, and corticosteroids that are applied to the skin.
Participants were randomly assigned to receive either Octagam or placebo. A placebo is a treatment that looks like the study medicine but does not contain any medicine. Neither the participants nor the researchers knew who was receiving Octagam during the first part of the study.
In the first 16 weeks of the study, treatment was given every four weeks for a total of four treatment cycles. After that, participants could continue into an extended part of the study that lasted 24 more weeks. During this part, everyone received Octagam every four weeks. The extended study was open-label, meaning the people knew they were receiving Octagam.
The main goal of the study was to see how many people had a meaningful improvement in their dermatomyositis symptoms.
What Are the Main Benefits of Octagam for Dermatomyositis Based on the Study?
The ProDERM study found that adults with active dermatomyositis were more likely to improve after 16 weeks of treatment with Octagam compared to placebo.
The main outcome measured during the study was the total improvement score (TIS). This score combines several signs of dermatomyositis improvement into one overall number. It includes changes in muscle strength, physical function, disease activity as rated by the participants and physicians, and levels of a muscle enzyme called creatine kinase. (Higher levels can be a sign of more active disease; lower levels can be a sign of improvement).
To count as a response, a participant had to have a TIS of 20 or higher, which was considered at least minimal improvement.
After 16 weeks:
- About 79% of participants who received Octagam had at least minimal improvement.
- About 44% of participants who received placebo had at least minimal improvement.
These results show that Octagam worked better than placebo for improving several signs and symptoms of dermatomyositis.
Your results may be different from what was seen in the clinical trial.
Are There Additional Potential Benefits of Octagam Based on Studies?
The study also looked at how many participants had larger improvements.
After 16 weeks:
- About 68% of participants who received Octagam had at least moderate improvement (TIS score of 40 or higher), compared with 23% of those who received placebo.
- About 32% of participants who received Octagam had major improvement (TIS score of 60 or higher), compared with 8% of those who received placebo.
People taking Octagam also tended to improve sooner. The median time to first noticeable improvement was about five weeks in the Octagam group. In the placebo group, it was about four months.
Skin symptoms also seemed to improve more with Octagam than with placebo. Researchers measured this using a scoring tool designed to assess skin disease in dermatomyositis.
In the extended part of the study, people who had first received placebo switched to Octagam. By week 40, their improvement scores had caught up to levels similar to those seen in people who received Octagam from the start. This suggests that Octagam may help even when it is started later.
Individual results may vary. Talk with your health care provider about whether Octagam is right for you and what to expect from treatment.
What Should I Expect Before, During, and After Octagam Infusions?
Octagam is given as an IV infusion, meaning it is given through a needle placed into a vein. Your infusion may be given at home, in a hospital, or at an infusion center. A health care provider will give the infusion and monitor you during treatment.
For dermatomyositis, Octagam is usually given once daily over two to five days in a row every four weeks. Each infusion may take several hours. The first infusion may take the longest because your health care team will usually start the infusion slowly and adjust the rate based on how you respond.
Before your Octagam infusion
Your health care provider may give you specific instructions before each infusion. General tips may include:
- Drink plenty of water the day before your infusion and on each treatment day.
- Avoid caffeine and alcohol.
- Bring something to help pass the time, such as a book, tablet, headphones, or other quiet activity.
- Wear comfortable clothing that allows easy access to your arm or infusion site. Consider bringing a sweater or dressing in layers, in case you get too cold or warm during the appointment.
During your Octagam infusion
During treatment, Octagam will be infused slowly through your vein. It typically takes four to five hours. The first dose may be longer, as this dose is given very slowly to help lower the risk of reactions.
Your health care team will monitor you during the infusion. This may include checking your blood pressure and temperature and watching for signs of an infusion reaction. If you are tolerating the medicine well, the infusion rate may be gradually increased.
Tell your health care provider right away if you notice symptoms such as headache, chills, fever, nausea, vomiting, dizziness, trouble breathing, chest tightness, wheezing, hives, itching, or swelling of your mouth or throat.
If you have a reaction, your health care provider may slow or stop the infusion and provide treatment if needed. If you start feeling better, your health care provider may resume your Octagam infusion at a slower rate and will continue to monitor you closely.
After your Octagam infusion
After your infusion, you may be able to return to your usual activities the same day if you feel well enough. Some people may feel tired or have side effects after treatment, such as headache, fever, chills, nausea, or vomiting. Contact your health care provider if you have side effects that concern you, do not go away, or get worse.
Your health care team can help you understand what side effects to watch for and what to do after each infusion. Read more to learn about Octagam side effects.
Is There Any Cost Assistance Available?
An Octagam cost assistance program is available through the drugmaker that may reduce the amount you pay. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured. Visit this website to see if you are eligible for copay savings. You can also call 844-448-4337 to connect with a representative about financial support options and other resources.
