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Understanding Biologics for Treating Psoriasis

Learn about different classes of biologics, their mechanisms of action, proper administration, potential side effects, and monitoring parameters for patients with psoriasis.

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Understanding Biologics for Treating Psoriasis

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  1. Treating Psoriasis:A Guide to Understanding Biologics Marlee R. Steele DNP, RN, FNP-BC

  2. Disclosures • I have no financial disclosures related to this lecture • Brand names as well as generic names are provided in the context of this talk for clarity

  3. Learning Objectives • The participant will be able to identify the different classes of biologics • The participant will be able to explain the mechanism of action of biologics • The participant will be able to recommend appropriate monitoring parameters for patients being treated with a biologic • The participant will be able to identify proper administration of biologics • The participant will be able to identify potential side effects of specific biologics

  4. Psoriasis: Brief Overview • Chronic noninfectious inflammatory disease of the skin • Pathologic Process not fully understood • Develops as secondary response triggered by T Lymphocytes • T-Cell activation leads to cytokine cascade leading to inflammation and proliferation of keratinocytes • Resulting in newly formed cells to move rapidly to the surface • This occurs every 3-4 days vs normal 26-28 days • Causing patches to appear

  5. Types of Psoriasis

  6. Biologic Medications • TNF-Alpha (TNF-α) Inhibitors • Interleukin-12/23 (IL-12/IL-23) Blockade Agents • Interleukin-17A

  7. TNF-Alpha (TNF-α) Inhibitors • TNF-α • Cytokine that promotes an inflammatory response • At high levels can trigger inflammatory response that leads to excessive keratinocyte proliferation • Patients with psoriasis have higher levels of TNF-α • TNF inhibitors bind TNF-α to neutralize its pro-inflammatory effects in psoriasis

  8. Adalimumab (Humira) • Fully human anti-TNF-α monoclonal antibody that binds to and blocks the activation of TNF-α • Approved for treatment of Moderate-to-Severe Psoriasis as well as Moderate-to-Severe Psoriatic Arthritis, Adult and Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Crohn’s Disease, and Hidradenitis Suppurativa

  9. (HumiraPro, 2017)

  10. Adalimumab (Humira) • Administration • Subcutaneous injection • Prefilled syringe/pen • Dosage and Frequency • 80mg day 1 • 40mg day 8 • 40mg day 22 • Continue 40mg every other week

  11. Adalimumab (Humira) • Monitoring • Baseline LFT, CBC, Hepatitis Profile, PPD • After initiation periodic CBC and LFT • Annual PPD • Half-Life • 10-20 days

  12. Adalimumab (Humira) • Drug Interactions • Methotrexate • Biological Products • Anakinra (Kineret) • Abatacept (Orencia) • Rituximab (Rituxan) • Live Vaccines • CYP450 Substrates

  13. Adalimumab (Humira) • Safety Considerations • Administered to adults 18 years of age and older • Pregnancy Category B • Consideration into stopping medication during pregnancy • Increased risk for developing serious infections • Patients >65 yrs. of age at greater risk of developing infection • Live vaccines should not be administered • Safety Considerations Cont. • Treat latent TB before use • Considerations for surgery • Adults should be up to date with immunizations • History of malignancy • Signs or symptoms of infection- patient should be instructed to discontinue medication

  14. Adalimumab (Humira) • Adverse Effects • Injections site pain, erythema, pruritus • Upper respiratory tract infection • Headache • Rash • Sinusitis • Increased Creatinine Phosphokinase • Nausea • UTI • Adverse Effects Cont. • Abdominal pain • Flulike symptoms • Hyperlipidemia • Back pain • Hypercholesterolemia • Hematuria • Hypertension • Increased alkaline phosphatase

  15. Adalimimab (Humira) • Black Box Warnings: • Serious Infection Risk • Not to be used with Active TB • May cause reactivation of latent TB • Treat latent TB infection before use • Invasive fungal infections may develop • Avoid use in patients with Hepatitis B infection • Bacterial infections such as Legionella, Listeria • Malignancy • Lymphoma (Hepatosplenic T-Cell Lymphoma) • Leukemia when being used for RA

  16. Etanercept (Enbrel) • Fully human fusion protein consisting of a soluble TNF receptor. Binds to both soluble and membrane bound TNF-α, lowering the amount of available TNF-α, decreasing the pro-inflammatory effects of TNF-α • Approved to treat moderate-to-severe psoriasis, moderate-to-severe psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis,

  17. jpet.aspetjournals.org

  18. Etanercept (Enbrel) • Administration • Subcutaneous injection • Prefilled syringe/auto injector • Adult: • Initial: >18 years of age 50mg SC twice weekly for 3 months • Maintenance: 50mg SC once weekly • Pediatric: • Initial: >4 years (<63kg)0.8mg/kg SC weekly not to exceed 50mg weekly • Initial: >4 years (>63kg): 50mg SC weekly • Dosage and Frequency • 50mg SC once weekly

  19. Etanercept (Enbrel) • Monitoring • Baseline LFT, CBC, Hepatitis Profile, PPD • After initiation periodic CBC and LFT • Annual PPD • Onset • 1-2 weeks • Half-Life • <5 days

  20. Etanercept (Enbrel) • Drug Interactions • Orencia • Kineret • Cyclophosphamide • Anti-diabetic medications • Live Vaccines

  21. Etanercept (Enbrel) • Safety Considerations • Pregnancy Category B • Consideration to stopping medication • Increased risk for developing serious infections • Patients >65 yrs. of age at greater risk of developing infection • Live vaccines should not be administered • Treat latent TB before use • History of Hepatitis B • Safety Considerations Cont. • Heart failure • Diabetes • Allergy to rubber or latex • Children and adults should be up to date with immunizations before starting drug • History of malignancy • Signs or symptoms of infection- patient should be instructed to discontinue medication

  22. Etanercept (Enbrel) • Adverse Effects • Upper respiratory tract infection • Non-upper respiratory tract infection • Headache • Rhinitis • Nausea • Adverse Effects Cont. • Dizziness • Pharyngitis • Abdominal pain • Vomiting • Hematologic disorders

  23. Etanercept (Enbrel) • Black Box Warnings • Serious Infection Risk • Not to be used with Active TB • May cause reactivation of latent TB • Treat latent TB infection before use • Invasive fungal infections may develop • Avoid use in patients with Hepatitis B infection • Bacterial infections such as Legionella, Listeria • Malignancy • Lymphoma • Leukemia in patient’s with RA

  24. Infliximab (Remicade) • Part mouse, part human monoclonal antibody that binds to soluble and membrane bound TNF-α molecules, inhibiting the pro-inflammatory action of TNF-α • Approved for treating severe psoriasis, moderate-to-severe psoriatic arthritis, adult rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, and Crohn’s disease

  25. jpet.aspetjournals.org

  26. Infliximab (Remicade) • Administration • IV infusion over 2 hours • Dosage and Frequency • 5mg/kg IV at 0,2, and 6 weeks then every 8 weeks

  27. Infliximab (Remicade) • Monitoring • Baseline LFT, CBC, Hepatitis Profile, PPD • After initiation periodic CBC and LFT • Annual PPD • Onset • Rapid onset • Half-Life • 7-12 days

  28. Infliximab (Remicade) • Drug Interactions • Live vaccines • Biologics • Kineret • Orencia • Actemra • Methotrexate • Immunosuppressant's • CYP450

  29. Infliximab (Remicade) • Safety Considerations • Pregnancy Category B • Consideration to stopping medication • Increased risk for developing serious infections • Patients >65 yrs. of age at greater risk of developing infection • Live vaccines should not be administered • Treat latent TB before use • Safety Considerations Cont. • History of Hepatitis B • History of malignancy • COPD • Immunizations should be current before therapy • Signs or symptoms of infection- patient should be instructed to discontinue medication

  30. Infliximab (Remicade) • Adverse Effects • Development of anti-drug neutralizing antibodies • Infection • Upper respiratory tract infection • Abdominal pain • Nausea • Adverse Effects Cont. • Infusion reaction • Headache • Diarrhea • Hepatoxicity • Congestive heart failure

  31. Infliximab (Remicade) • Black Box Warnings • Serious Infection Risk • Not to be used with Active TB • May cause reactivation of latent TB • Treat latent TB infection before use • Invasive fungal infections may develop • Avoid use in patients with Hepatitis B infection • Bacterial infections such as Legionella, Listeria • Malignancy • Lymphoma (Hepatosplenic T-Cell Lymphoma)

  32. TNF-α Inhibitor’s Overview • All TNF Inhibitors carry potential for increased risk for infection with upper respiratory tract infections being the most common • Serious infections are uncommon, with patients with underlying predisposing medical conditions being more at risk • In the event of an infection requiring an antibiotic the TNF Inhibitor should be withheld, and more serious infections or opportunistic infections the TNF Inhibitor should be discontinued • TNF Inhibitors should be avoided if possible in patient’s with chronic, serious, or recurring infections • Reactivation of TB has been associated with TNF Inhibitors

  33. Interleukin 12/23 Blockade Agents • IL-12 promotes T-cell differentiation into Th1 cells and production of IFN-ϒ • IL-23 induces differentiation of the TH17 T-cell that leads to inflammation and autoimmunity • IL-12 and IL-23 contain a p40 subunit that is over-expressed in psoriasis patients causing elevated levels of IL-12/23

  34. www.nature.com

  35. Ustekinumab (Stelara) • Monoclonal human antibody that targets IL-12/IL-23 chemical messengers • Approved to treat moderate-to-severe plaque psoriasis, psoriatic arthritis, and crohn’s disease in patients 18 years of age and older

  36. Ustekinumab (Stelara) • Administration • Subcutaneous Injection (pre-filled syringes) • IV Infusion • Dosage and Frequency • ≤100kg: 45mg SC initially, then 4 weeks later 45mg SC, and then every 12weeks 45mg SC • >100kg: 90mg SC initially, then 4 weeks later give 90mg SC, and then every 12 weeks 90mg SC

  37. Ustekinumab (Stelara) • Monitoring • Baseline LFT, CBC, Hepatitis Profile, PPD • After initiation periodic CBC and LFT • Annual PPD • Half-Life • 10-126 days

  38. Ustekinumab (Stelara) • Drug Interactions • Live Vaccines • CYP450 Substrates • Concomitant Therapies • Allergen Immunotherapy

  39. Ustekinumab (Stelara) • Safety Considerations • Pregnancy Category B • Pregnancy should be avoided while on medication • Increased risk for developing serious infections • Patients >65 yrs. of age at greater risk of developing infection • Live vaccines should not be administered • Treat latent TB before use • History of malignancy • Immunizations should be current before therapy • Signs or symptoms of infection- patient should be instructed to discontinue medication

  40. Ustekinumab (Stelara) • Adverse Effects • Upper respiratory infection • Nasopharyngitis • Back pain • Cellulitis • Depression • Diarrhea • Fatigue • Adverse Effects Cont. • Headache • Injection site erythema • Myalgia • Nasal Congestion • Urticaria • Rash

  41. Ustekinumab (Stelara) • Warnings • May increase risk of infections and/or reactivation of latent infections • Increased risk of malignancy • Non-melanoma skin cancers • May decrease the protective effect of allergen immunotherapy • One reported case of Reversible Posterior Leukoencephalopathy Syndrome • Avoid pregnancy

  42. Interleukin 12/23 Blockade Agents Overview • Serious infections may occur from mycobacteria, salmonella, and BCG vaccinations in patients genetically deficient in IL-12/IL-23 • Evaluate patients for TB • May increase the risk of malignancy • Hypersensitivity reactions • Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

  43. Interleukin-17A (IL-17A) • Monoclonal antibodies that that target and block the actions of IL-17A • Used in the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis

  44. Secukinumab (Cosentyx) • Administration • 150mg prefilled syringe or sensoready pen • Subcutaneous Injections • Adults >18 years of age • Dosage/Frequency • 300mg SC at weeks 0,1,2,3, and 4 • Monthly maintenance beginning at week 8, 300mg SC once monthly

  45. www.cosentyx.com

  46. Secukinumab (Cosentyx) • Monitoring • Baseline LFT, CBC, Hepatitis Profile, PPD • After initiation periodic CBC and LFT • Annual PPD • Half-Life • 22-31 days

  47. Secukinumab (Cosentyx) • Safety Considerations • Pregnancy Category B • While Category B it is recommended to stop medication • Live vaccines should not be administered • Caution in considering use in patients with chronic infection or history of recurrent infection • Immunizations should be current before therapy • Treat latent TB before use • May exacerbate Crohn’s Disease

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