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ustekinumab (Stelara, Wezlana, Pyzchiva, Selarsdi)

Indications: - adult plaque psoriasis (moderate to severe psoriasis) resistant to methotrexate, PUVA, cyclosporine or contraindication to these agents - psoriatic arthritis [3] - inflammatory bowel disease, enteropathic arthritis - FDA-approved for Crohn's Disease [5] - appears to be effective for ulcerative colitis [7] * less robust effect than other biologic DMARDs [3] Contraindications: - clinically significant active infection - NICE does not recommend for psoriatic arthritis Pregnancy category: B [3] Dosage: - plaque psoriasis - < 100 kg: 45 mg SC at weeks 0 & 4, then q12 weeks thereafter - > 100 kg: 90 mg SC at weeks 0 & 4, then q12 weeks thereafter - 45mg/0.5mL (prefilled syringe) (Stelara, Selarsdi, Wezlana, Pyzchiva) - 45mg/0.5mL (single-dose vial) (Stelara, Wezlana) - 90mg/mL (prefilled syringe) (Stelara, Selarsdi, Wezlana, Pyzchiva) Monitor: - screening for tuberculosis [3] - CBC, basic metabolic panel, LFTs at baseline & every 3 months thereafter [3] Adverse effects: 1) immmosuppression - increased risk of 1] fungal infection 2] viral infection 3] bacterial infection - no increased risk of serious infectious when used to treat psoriasis [4] 2) depression, headache, dizziness, fatigue 3) diarrhea 4) pruritus 5) back pain 6) injection site erythema 7) may increase risk of malignancies 8) interstitial pneumonia (FDA investigating) [6] 9) cardiovascular events may occur in susceptible patients upon initiation of treatment [8] Laboratory: - ustekinumab in serum/plasma - ustekinumab Ab in serum/plasma Mechanism of action: - human monoclonal antibody directed against interleukin-12 & interleukin-23 Management: - whenever possible bring patients up to date on vaccinations prior to initiating biologic immunosuppressive agent [3]

Interactions

drug adverse effects of immunosuppressive agents monitor with immunosuppressive agents

General

biologic immunosuppressive agent (biologic agent, biologic immune modulator) pharmaceutical monoclonal antibody dermatologic agent

References

  1. FDA News release http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm
  2. Prescriber's Letter 16(11): 2009 Stelara (Ustekinumab) for Psoriasis Detail-Document#: 251125 (subscription needed) http://www.prescribersletter.com
  3. Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18, 19. American College of Physicians, Philadelphia 2012, 2015, 2018, 2022.
  4. Kalb RE, Fiorentino DF, Lebwohl MG et al Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis: Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). JAMA Dermatol. 2015 May 13 PMID: 25970800
  5. Brooks M FDA Clears Ustekinumab (Stelara) for Crohn's Disease. Medscape. Sep 26, 2016. http://www.medscape.com/viewarticle/869259
  6. Lowes R New FDA Watch List Flags More Drugs Medscape Internal Medicine. July 3, 2017 http://www.medscape.com/viewarticle/882425
  7. Sands BE, Sandborn WJ, Panaccione R et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2019 Sep 26; 381:1201. PMID: 31553833 https://www.nejm.org/doi/10.1056/NEJMoa1900750
  8. Swift D Study Results Suggest Ustekinumab May Trigger Acute CV Events Early in Treatment Medscape - Sep 18, 2020. https://www.medscape.com/viewarticle/937686
  9. Medscape: ustekinumab (Rx) https://reference.medscape.com/drug/stelara-wezlana-ustekinumab-345050