Biologics

Biological response modifiers, or “biologics” are a highly effective treatment option for patients with moderate to severe psoriasis.

While some drugs are small molecules that are synthesized chemically, biologics are produced by living cells and are significantly larger and more complex. Because of their size, they will not be absorbed orally and must be given through injections. Biologics can stop the body from harming itself by blocking signalling molecules involved in inflammation such as TNF-Alpha (tumour necrosis factor-alpha), interleukin 17-A or interleukins 12 and/or 23.   

Before treatment begins, people generally have routine tests performed to ensure that there are no existing medical problems that could complicate treatment.  During treatment with a biologic or any immunomodulating mediation, if you have or develop a serious infection, your doctor might instruct you to stop your treatment until you are better. Always talk with your healthcare provider before stopping your medication. 

Dosage Form

Most biologics are given by a simple injection into fatty tissue (subcutaneous), like an insulin injection.  Some are given by intravenous (IV) infusion. 

Subcutaneous injections can be administered by a nurse or by the patient themselves after proper training. Patients usually receive training when they first start a new biologic. It is a good idea to revisit your injection technique with your doctor or pharmacist occasionally to ensure you are administering your dose correctly.

Intravenous infusions are usually administered by a nurse in an infusion clinic. The patient support program associated with your biologic will usually help to set up your first infusion at a clinic of your choice. You can discuss your options with your healthcare provider. 

Biosimilars 

A biosimilar (also referred to as a subsequent entry biologic) is a similar but not identical version of an existing reference biologic (also called an originator biologic). Biosimilars become available on the market once the patent for the reference drug has expired. The reference drug is the first drug of its kind to be developed and as such, the drug company that makes it gets to be the sole manufacturer of that drug for a certain length of time. Once that time is up, other manufacturers are permitted to create biosimilars. We say that biosimilars are similar to the originator but not exactly the same because it is impossible to make an identical copy of a biologic due to its intrinsic complexity. Additional testing and research are done on biosimilars to ensure that they have the same efficacy and safety as the originator version of the biologic. 

For more information, please see our position on biosimilars

TNF-Alpha inhibitors

TNF-alpha inhibitors block tumour necrosis factor (TNF), a signalling molecule that, in psoriasis, triggers an immune response against the skin. By blocking this signal, we stop the body from attacking itself, improve skin clearance and reduce symptoms of redness, scaling, burning, stinging, cracking, flaking, and pain. 

TNF inhibitors are widely used for conditions where the body attacks itself (autoimmune conditions) such as rheumatoid arthritis or psoriatic arthritis. They have a long history of use and a well-documented and predictable side effect profile.

TNF-alpha inhibitors

  1. Adalimumab
  2. Certolizumab
  3. Etanercept
  4. Infliximab

Potential Side Effects 

Potential side effects include injection site reactions such as pain, redness, swelling, itching, or bruising at the injection site. Since TNF-alpha inhibitors may reduce your ability to fight off infections, patients may be at a higher risk of developing upper respiratory infections (i.e. cold, flu), pneumonia, bronchopneumonia, bronchitis, and herpes zoster (shingles). Tell your doctor if you develop any signs of infection such as a fever or if you experience infections that are not getting better or that keep coming back. You should also tell your doctor if you have a history of tuberculosis or hepatitis, if you require a live vaccine (eg. MMR, Shingrix, nasal spray flu vaccine), or if you are pregnant or nursing.

Cost Considerations

Biologics are expensive. Public insurance, private insurance, and other coverage options may be available to help patients cover the cost of these therapies. Each biologic has an associated patient support program that helps patients to navigate the healthcare system and identify what coverage is available to them.

 Learn more about patient support programs.Learn more about patient support programs.

Drug Profiles (TNF-Alpha inhibitors)

Please note that the dosing schedules listed below represent the product monograph dosing of these drugs.  Occasionally physicians experienced in the treatment of psoriasis may recommend a higher or lower dose than listed below.  Please discuss all dosing questions with your physician.

ADALIMUMAB

Originator: Humira

Biosimilars: Abrilada Amgevita, Hadlima, Hulio, Hyrimoz, Idacio, Simlandi*, Yuflyma*

*Simlandi and Yuflyma recently received Health Canada approval and will soon be commercially available in Canada

 

Time Frame

Patients can start to see benefits after 2-3 weeks, but response is best determined after 3-4 months of therapy.

 

Dosage Form

Pre-filled syringe 

Autoinjector

Dose and frequency

The usual dose is 80 mg injected subcutaneously as an initial dose  followed by 40 mg injected subcutaneously every other week starting one week after initial dose 

         

Patient Support Program

Humira: Abbvie Care 1-866-848-6472

Abrilada: PfizerFlex 1 855 935 3539

Amgevita: Enliven Services 1-877-936-2735

Hadlima: Harmony by Organon 1-866-556-5663

Hulio: Viatris Advocate Program 1-844-485-4677

Hyrimoz: Xpose by Sandoz 1-888-449-7673

Idacio: KabiCare 1-888-304-2034

Interleukin inhibitors can prevent specific proteins in the body—called interleukins—from causing the body’s immune system to attack the skin and nails and other structures. The medicines work by neutralizing the activities of various interleukins which are present at increased levels in diseases such as psoriasis. By blocking this signal, we stop the body from attacking itself and improve skin clearance and reduce symptoms of redness, scaling, burning, stinging, cracking, flaking, and pain. 

 

Potential Side Effects

Potential side effects include injection site reactions such as pain, redness, swelling, itching, or bruising at the injection site. Since interleukin inhibitors may reduce your ability to fight off infections, patients may be at a higher risk of developing upper respiratory infections (i.e. cold, flu), pneumonia, bronchopneumonia, bronchitis, and herpes zoster (shingles). Tell your doctor if you develop any signs of infection such as a fever or if you experience infections that are not getting better or that keep coming back. You should also tell your doctor if you have a history of tuberculosis or hepatitis, if you require a live vaccine (eg. MMR, Shingrix, nasal spray flu vaccine), or if you are pregnant or nursing.

Interleukin Inhibitors 

BIMEKIZUMAB

(Brand Name: Bimzelx)

 What it does / How it works

Bimekizumab works by inhibiting the inflammatory proteins known as IL-17A and IL-17F. These inflammatory proteins are present in increased levels in psoriasis and by inhibiting them, this medication can help to achieve skin clearance and improvement in psoriasis symptoms. Dosage Form

            Pre-filled syringe

            Autoinjector

Dosage and Frequency

The usual dose is 320 mg given as two 160 mg injections every 4 weeks for the first 16 weeks, and then every 8 weeks thereafter. If you weigh more than 120 kg, your healthcare professional may decide to continue your injections every 4 weeks from week 16. Follow your doctor’s instructions for optimal dosing.

 

   Patient Support Program

Contact UCB Cares  1-800-908-5555