ustekinumab (Stelara)
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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
Dosage
- 45 mg (injection)
- 90 mg if > 100 kg
Monitor
- screening for tuberculosis[3]
- CBC, basic metabolic panel, LFTs at baseline & every 3 months thereafter[3]
Adverse effects
- immmosuppression
- increased risk of
- no increased risk of serious infectious when used to treat psoriasis[4]
- depression, headache, dizziness, fatigue
- diarrhea
- pruritus
- back pain
- injection site erythema
- may increase risk of malignancies
- interstitial pneumonia (FDA investigating)[6]
- cardiovascular events may occur in susceptible patients upon initiation of treatment[8]
- drug adverse effects of immunosuppressive agents
- drug adverse effects of biologic immunosuppressive agents
- drug adverse effects of pharmaceutical monoclonal antibodies
Laboratory
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]
More general terms
References
- ↑ FDA News release http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm
- ↑ Prescriber's Letter 16(11): 2009 Stelara (Ustekinumab) for Psoriasis Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=251125&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18, 19. American College of Physicians, Philadelphia 2012, 2015, 2018, 2022.
- ↑ 4.0 4.1 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: https://www.ncbi.nlm.nih.gov/pubmed/25970800
- ↑ 5.0 5.1 Brooks M FDA Clears Ustekinumab (Stelara) for Crohn's Disease. Medscape. Sep 26, 2016. http://www.medscape.com/viewarticle/869259
- ↑ 6.0 6.1 Lowes R New FDA Watch List Flags More Drugs Medscape Internal Medicine. July 3, 2017 http://www.medscape.com/viewarticle/882425
- ↑ 7.0 7.1 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: https://www.ncbi.nlm.nih.gov/pubmed/31553833 https://www.nejm.org/doi/10.1056/NEJMoa1900750
- ↑ 8.0 8.1 Swift D Study Results Suggest Ustekinumab May Trigger Acute CV Events Early in Treatment Medscape - Sep 18, 2020. https://www.medscape.com/viewarticle/937686