risankizumab

Action and Spectrum

Actions and Spectrum: 

risankizumab is a monoclonal antibody used as a medication for certain inflammatory conditions.  

Action: risankizumab primarily works by inhibiting a protein called interleukin-23 (IL-23). IL-23 is involved in the immune system’s inflammatory response and is known to play a role in several autoimmune diseases. By blocking IL-23, risankizumab helps regulate the immune response and reduce inflammation. 

Spectrum: risankizumab is primarily indicated for treating moderate to severe plaque psoriasis, a chronic autoimmune skin condition characterized by the thick, scaly patches on the skin, and also used to treat psoriatic arthritis. 

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

Crohn disease 

Upper respiratory tract infections (10.6%) 

Plaque psoriasis 

Upper respiratory tract infections (13%) 

1-10% 

Crohn disease 

Arthropathy (3.5%) 

Headache (6.6%) 

Abdominal pain (8.5%) 

Urinary tract infection (3.5%) 

Injection site reactions (5.6%) 

Back pain (4.2%) 

Anemia (4.9%) 

Pyrexia (4.9%) 

Arthralgia (5-9.2%) 

Plaque psoriasis 

Fatigue (2.5%) 

Injection site reactions (1.5%) 

Headache (3.5%) 

Tinea infections (1.1%) 

<1% 

Severe infections like cellulitis, sepsis, osteomyelitis, herpes zoster 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

The contraindications for risankizumab include: 

• Hypersensitivity: risankizumab should not be used in individuals with known hypersensitivity or allergy to risankizumab or its components. 

Caution 

Here are some general cautions: 

• Infections: risankizumab may increase the risk of severe and potentially life-threatening infections. Before starting treatment, evaluating individuals for any active or latent infections is essential. Caution should be exercised when considering risankizumab use in individuals with a history of recurrent infections/underlying conditions that might predispose them to infections. 
• Tuberculosis: Before initiating treatment with risankizumab, individuals should be screened for tuberculosis (TB) infection. Treatment for latent TB should be completed before starting risankizumab. If active TB is suspected during treatment, appropriate anti-TB therapy should be initiated. 
• Immunizations: Live vaccines should not be administered concurrently with risankizumab. It is recommended to complete any necessary immunizations before starting treatment with risankizumab. 
• Malignancies: Caution should be exercised when considering risankizumab use in individuals with an earlier history of malignancy or those with a higher risk of developing malignancies. The long-term effects of risankizumab on the development of malignancies need to be well-established. 
• Hypersensitivity Reactions: Serious hypersensitivity reactions like anaphylaxis, have been reported using risankizumab. If a hypersensitivity reaction occurs, appropriate medical management should be initiated. 

Pregnancy / Lactation

Pregnancy consideration:  

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned 

Lactation:   

Excreted into human milk: N/A 

Breastfeeding warnings:  

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    
• Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

risankizumab is a monoclonal antibody that selectively targets interleukin-23 (IL-23), a cytokine involved in the immune system’s inflammatory response.  

risankizumab binds to the p19 subunit of the IL-23, preventing the interaction of IL-23 with its receptor. This binding inhibits the signaling pathway that leads to the activation and also proliferation of T cells, which play a important role in the pathogenesis of certain autoimmune diseases. 

Pharmacodynamics: 

Mechanism of action: The action of risankizumab involves selectively targeting and inhibiting interleukin-23 (IL-23), a cytokine involved in the immune system’s inflammatory response. Here is a detailed explanation of its mechanism of action: 

• IL-23 Signaling Pathway: IL-23 is a cytokine that plays a important role in the pathogenesis of various autoimmune diseases, including psoriasis and psoriatic arthritis. It is primarily produced by immune cells, such as dendritic cells and macrophages, in response to inflammatory stimuli. 
• Binding to IL-23: risankizumab is a monoclonal antibody that mainly binds to the p19 subunit of IL-23. By binding to IL-23, risankizumab prevents IL-23 from interacting with its receptor on target cells. 
• Inhibition of IL-23 Signaling: The binding of risankizumab to IL-23 inhibits the IL-23 signaling pathway. This blocks the downstream signaling events that normally lead to T cells’ activation and proliferation. 
• Modulation of the Immune Response: By inhibiting IL-23 signaling, risankizumab helps regulate the immune response. IL-23 drives the production of pro-inflammatory cytokines, particularly IL-17A, IL-17F, IL-22, and IL-6. By blocking IL-23, risankizumab reduces the production of these pro-inflammatory cytokines, thereby modulating the immune response and reducing inflammation. 
• Effects on Autoimmune Diseases: The modulation of IL-23 signaling by risankizumab has therapeutic implications for autoimmune diseases characterized by excessive inflammation, such as plaque psoriasis and psoriatic arthritis. By targeting IL-23, risankizumab helps control the underlying inflammatory processes and relieves symptoms associated with these conditions. 

Pharmacokinetics: 

Absorption 

risankizumab is administered via subcutaneous injection. After injection, the absorption of risankizumab into the systemic circulation is relatively slow and gradual. 

Distribution 

As a monoclonal antibody, risankizumab has a relatively large molecular size, restricting its distribution to the vascular compartment. It is expected to distribute like other monoclonal antibodies, with limited penetration into extravascular tissues. 

Metabolism 

As a monoclonal antibody, it is expected to undergo proteolysis and catabolism into smaller peptides and amino acids. However, the specific metabolic pathway and enzymes involved in the metabolism of risankizumab have yet to be extensively studied or characterized. 

Elimination and Excretion 

The exact route of excretion of risankizumab has yet to be fully elucidated. It is expected to undergo elimination from the body through proteolytic degradation and clearance via the reticuloendothelial system. The terminal elimination half-life of risankizumab is approximately 27 days, suggesting a slow clearance from systemic circulation. 

Adminstartion

Administration: 

Subcutaneous administration 

risankizumab is typically administered by subcutaneous injection. Here are some general guidelines for the administration of risankizumab: 

• Healthcare Professional Administration: risankizumab injections are typically administered by healthcare professionals in a clinical setting, such as a doctor’s office, clinic, or hospital. They are trained in the proper technique for administering subcutaneous injections. 
• Dosage and Schedule: The dosage and dosing schedule of risankizumab may vary depending on the specific condition being treated. It is key to follow the prescribed dosage and schedule as directed by the healthcare professional. 
• Preparation: risankizumab is usually available as a prefilled syringe or pen. Before administration, the healthcare professional will check the medication for any signs of damage or contamination. 
• Injection Site: The injection site for risankizumab is typically the thigh or abdomen. The healthcare professional will choose an appropriate injection site and clean the area with an antiseptic solution. 
• Injection Technique: The healthcare professional will use a sterile needle to administer the injection subcutaneously, injecting the medication just beneath the skin. They will follow the appropriate technique to ensure accurate and safe administration. 
• Monitoring: After the injection, the healthcare professional may observe the individual briefly to monitor for any immediate adverse reactions. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: risankizumab 

Pronounced: [ RIS-an-KIZ-ue-mab ] 

Why do we use risankizumab? 

risankizumab is primarily used to treat certain inflammatory conditions, specifically plaque psoriasis and psoriatic arthritis. Here are the primary uses of risankizumab: 

• Plaque Psoriasis: It is a chronic autoimmune skin condition characterized by red, raised, and scaly patches on the skin. risankizumab is indicated for treating moderate-severe plaque psoriasis in adults who are individuals for systemic therapy/phototherapy. It helps to reduce the inflammation and symptoms associated with plaque psoriasis, improving the appearance of the skin and reducing itching and discomfort. 
• Psoriatic Arthritis is type of arthritis that affects some individuals with psoriasis. It causes joint pain, stiffness, swelling, and skin symptoms. risankizumab is also approved for the treatment of active psoriatic arthritis in adults. risankizumab helps reduce joint symptoms and improve overall function by targeting the underlying inflammation.