Biologics

Biologics are different from traditional systemic drugs that impact the entire immune system. Biologics only target specific parts of the immune system. The biologics used to treat psoriatic disease block the action of a specific type of immune cell called a T-cell. Or they block proteins in the immune system, such as tumor necrosis factor-alpha (TNF-alpha), interleukin 17-A or interleukins 12 and 23. These cells and proteins all play a major role in developing psoriasis and psoriatic arthritis (PsA).  

Biologics such as Enbrel, Humira and Remicade are also considered disease-modifying antirheumatic drugs (DMARDs), which means they attempt to slow or stop the processes in the body that cause joint damage. They target a cytokine, or protein, called tumor necrosis alpha-factor (TNF-alpha) that causes psoriasis and PsA.

Your health care provider can share more information about biologics and if they’re the best treatment for you.

How Are Biologics Used?

Biologics are taken by injection or by IV infusion depending on label. Some injections you may even be able to do at home by yourself or with a family member. Your health care provider will be able to provide you with more information related to your treatment.

Biologics are prescribed for individuals with plaque psoriasis and psoriatic arthritis. They are a viable option for those who have not responded to or have experienced harmful side effects from other treatments.

Biologics can have multiple indications. Often, they are indicated for moderate to severe plaque psoriasis, but may include other types of psoriasis and psoriatic arthritis.

Your health care provider can help determine if biologics are the appropriate treatment for you.

Screening for tuberculosis (TB) or other infectious diseases is often required before starting treatment with biologics.

What Are the Risks of Biologics?

Anyone considering taking a biologic should talk with his or her health care provider about the short- and long-term side effects and risks. It is important to weigh the risks against the benefits of using the drugs.

Biologics can increase the risk of infection. If you develop any sign of an infection, such as a fever, cough or flu-like symptoms, you should contact your health care provider right away.

Using Biologics with Other Psoriasis Treatments

All the current biologics can be used with other treatments such as phototherapy or topicals, though using phototherapy along with Remicade may increase your skin cancer risk.

Cimzia, Enbrel, Humira and Remicade are shown to be safe and effective when taken with methotrexate. Talk to your health care provider about whether using any other treatments with a biologic is right for you.

Current Biologics on the Market

Tumor Necrosis Factor-Alpha (TNF-alpha) Inhibitors

Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), Simponi (golimumab) and Simponi Aria (golimumab) are drugs that block TNF-alpha. TNF-alpha is a cytokine that prompts the body to create inflammation. In psoriasis and psoriatic arthritis, there is excess production of TNF-alpha in the skin or joints. That leads to the rapid growth of skin cells and/or damage to joint tissue. Blocking TNF-alpha production helps stop the inflammatory cycle of psoriatic disease.

To learn more, please visit the Cimzia website.

Interleukin 12 and 23 (IL-12/23) Inhibitors

Stelara (ustekinumab) works by selectively targeting the proteins, or cytokines, interleukin 12 (IL-12) and interleukin 23 (IL-23). Interleukins 12/23 are associated with psoriatic inflammation.

To learn more, please visit the Stelara website.

Interleukin 17 (IL-17) Inhibitors

Cosentyx (secukinumab) and Taltz (ixekizumab) block a cytokine called interleukin 17 (IL-17), which is involved in inflammatory and immune responses. Siliq (brodalumab) blocks the receptor of this cytokine, the IL-17 receptor A (IL-17 RA), through which IL-17 mediates the inflammatory and immune responses. There are elevated levels of IL-17 in psoriatic plaques. By interfering with IL-17 signaling, Cosentyx, Siliq and Taltz interrupt the inflammatory cycle of psoriasis, which can lead to symptom improvement for many people who take it.

To learn more, please visit the Cosentyx website.

To learn more, please visit the Taltz website.

T-Cell Inhibitors

Orencia (abatacept) targets T-cells in the immune system. T-cells are a type of white blood cell that is involved in the inflammation in psoriatic disease. Orencia inhibits T-cells from becoming activated to reduce inflammation.

Interleukin 23 (IL-23) Inhibitors

Ilumya (tildrakizumab-asmn), Skyrizi (risankizumab-rzaa) and Tremfya (guselkumab) work by targeting interleukin 23 (IL-23). This cytokine is linked with inflammation in psoriasis and PsA. Ilumya, Skyrizi and Tremfya work to reduce psoriatic symptoms and slow disease progression.

To learn more, please visit the ILUMYA website.

To learn more, please visit the Skyrizi website.

To learn more, please visit the Tremfya website.

Cimzia

Cimzia (also known by its generic name certolizumab pegol) is a biologic medication approved in September 2013 by the FDA for the treatment of active psoriatic arthritis. It is also approved for treating rheumatoid arthritis and Crohn's disease.

Cimzia is given by injection under the skin. The recommended dose for psoriatic arthritis is 400 milligrams (given as two injections of 200 milligrams each) initially and at week two and week four, followed by a dose of 200 milligrams every other week. Cimzia is designed to be taken continuously to maintain improvement.

To learn more, please visit the Cimzia website.

Enbrel

The drug Enbrel (also know by its generic name etanercept) is a TNF-alpha inhibitor that was approved for people with moderate to severe psoriatic arthritis in January 2002 and for psoriasis in April 2004. It also is approved for treating rheumatoid arthritis, ankylosing spondylitis and juvenile idiopathic arthritis.

Studies have shown that Enbrel reduced the progression of joint damage for two years among individuals with psoriatic arthritis. Treatment consists of once- or twice-weekly self-injections under the skin. The recommended dose for adults with psoriatic arthritis is 50 mg per week.

To learn more, please visit the Enbrel website.

Humira

Humira (also know by its generic name adalimumab) is a TNF-alpha inhibitor approved by the FDA in October 2005 to treat psoriatic arthritis and in January 2008 to treat psoriasis. It is also approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and Crohn's desease.

The recommended dose for adults is 40 milligrams (mg) every other week. The drug is injected under the skin by the individual.

To learn more, please visit the Humira website.

Remicade

Remicade (also known by its generic name infliximab) was approved by the FDA in May 2005 to treat psoriatic arthritis and in September 2006 to treat psoriasis. It is also approved for ankylosing spondylitis, ulcerative colitis, rheumatoid arthritis and Crohn's disease.

During the first six weeks of treating psoriatic arthritis with Remicade, individuals receive 5 mg of the drug per kilogram (kg) of body weight in three infusions in a doctor's office. After the first three treatments, individuals continue to receive Remicade infusions at regular intervals of eight weeks. Similar to Enbrel and Humira, Remicade is an anti-TNF-alpha drug.

To learn more, please visit the Remicade website.

Simponi

Simponi (also known by its generic name golimumab) was approved by the FDA in April 2009 to treat adults with moderate to severe psoriatic arthritis. It is also approved for rheumatoid arthritis and ankylosing spondylitis.

Patients take Simponi by giving themselves an injection under the skin. The recommended dose for patients with psoriatic arthritis is 50 mg once a month. Simponi also is a TNF-alpha inhibitor. Simponi is designed to be taken continuously to maintain improvement.

To learn more, please visit the Simponi website.

Stelara

Stelara (also known by its generic name ustekinumab) was approved by the FDA in September 2009 for the treatment of moderate to severe plaque psoriasis. In September 2013 the FDA also approved Stelara to treat adults with psoriatic arthritis.

Stelara is given by injection under the skin at week 0 (the first week of treatment) and week 4, and then every 12 weeks afterwards. The recommended starting dose is 45 mg for individuals weighing 220 lbs or less, and 90 mg for those who weigh more than 220 lbs.

To learn more, please visit the Stelara website.

Biosimilars

Biosimilar medicines are a type of biologic drug, and may be administered via injections of intravenous infusion. Although biosimilars are modeled after an FDA-approved biologic medicine or biologic, they undergo different approval processes. The FDA can approve a treatment as a biosimilar or an interchangeable biosimilar. FDA standards ensure that biosimilars and interchangeable biosimilars are just as safe and effective as their biologic reference product.

Relationship Between Biosimilars and Biologics

Biosimilars are highly similar to their biologic reference product. All biologics, including biosimilars:

  • Target specific parts of the immune system rather than impacting the entire immune system
  • Are given as an injection or IV infusion

To be approved as a biosimilar for a particular reference biologic, the biosimilar must be:

  • Highly similar to the reference product and cannot have any clinically meaningful differences in terms of safety or efficacy
  • Approved for the indication(s) and condition(s) for which the reference product is approved
  • Be given the same form and in the same dosage as the reference product
  • The same mechanism of action as the reference product, which means it works the same way in the body

An interchangeable biosimilar must meet the biosimilar standard plus an additional standard that the treatment will produce the same clinical result as the reference product in any given patient. If a biosimilar is approved as interchangeable, a pharmacist may substitute it without letting your prescribing health care provider know, in some states.

Keep in mind that biosimilars are not exact copies of their biologic reference product. Biologics are large and complex molecules from living sources that cannot be exactly copied.

Many considerations go into a treatment decision. Always speak with your health care provider about the potential risks and benefits of a treatment recommendation.

FDA-Approved Biosimilars

There are now three biosimilars approved for the treatment of psoriasis and PsA:

  • Amjevita (adalimumab-atto) and Cyltezo (adalimumab-adbm) are biosimilar medicines to Humira (adalimumab)
  • Erelzi (etanercept-szzs) is a biosimilar medicine to Enbrel (etanercept)
  • Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda) are biosimilar medicines to Remicade (infliximab)

Although these have been approved by the FDA, your health care provider may not be able to prescribe these treatments yet. There are other biosimilars currently being developed and tested. These may be approved and available in the future.

Who Can Take Biosimilars?

All biologics, including biosmilars, are typically prescribed for people with more advanced disease, including individuals with moderate-to-severe psoriasis and active PsA. But each of the three approved biosimilars are indicated for different groups within this population.

You should not take biosimilars if:

  • Your immune system is significantly compromised
  • You have an active infection

Screening for tuberculosis or other infectious diseases is required before starting treatment with all biologics, including biosimilars.

What Are the Risks of Biosimilars?

The risks and side effects of biosimilars are the same as those associated with their biologic reference product. Anyone considering taking a biosimilar should talk with their health care provider about the short- and long-term side effects and risks. It is important to weigh the risks against the benefits.

Biologics and biosimilars act on cytokines, which are specific proteins released by the immune system that can cause inflammation. Biologics suppress the function of the overactive immune system. When on a biologic or biosimilar, you may have a higher risk of infection. If you develop any signs of an infection, contact your health care provider right away.

Signs of infection include:

  • Chills
  • Damp, sticky feeling or sweating
  • Fever
  • Nasal (nose) or chest congestion
  • Pain or burning when urinating
  • Shortness of breath
  • Skin redness, swelling, soreness or warmth

The impact of biologics on developing fetuses or nursing infants is not known. Biologics should only be prescribed to pregnant or nursing women if there is a clear medical need.

Common side effects for biosimilars may include:

  • Abdominal pain
  • Flu-like symptoms
  • Headache
  • Injection site reactions
  • Upper respiratory infections

Call your health care provider if you are experiencing any side effects with biosimilars.

Can Biosimilars Be Used With Other Treatments?

It is important to tell your health care provider about all treatments, medicines, vitamins or supplements that you are taking.

Like all biologics, biosimilars can be used with other treatment options including topicals and phototherapy. The biologics Enbrel, Humira and Remicade are shown to be safe and effective when taken with methotrexate. This means that their biosimilars, including Erelzi, Amjevita, and Inflectra, may be safe and effective when taken with methotrexate.

  • With Inflectra being the biosimilar to Remicade, its use in combination with phototherapy may increase the risk for skin cancer.
  • No drugs that interact with biologics should be combined with their respective biosimilars.

Biosimilar Substitution

NPF’s medical board has issued a statement on biosimilar substitution.

From the statement:

NPF urges that the patient-provider relationship remain at the center of all treatment planning and recommends that the following minimal thresholds are met for biosimilar substitution to occur:

  1. the biosimilar has been designated by the FDA as interchangeable with the prescribed biologic for the specified indicated use;
  2. the biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic agent in a patient's permanent record, and to allow for the collection of adverse event information;
  3. the biosimilar product follows the same route of administration and dosage form as the reference product;
  4. the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute within 48 hours of the substitution;
  5. the prescribing physician has not indicated the patient must be treated with the prescribed biologic (via instruction to the pharmacist to dispense as written);
  6. the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
  7. upon notification of a substitution, the pharmacy and the prescribing physician are to retain a permanent record in the patient's medical record of the biosimilar substitution.

Get the Facts About Biologics and Biosimilars

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