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guselkumab (Tremfya)

Indications: - treatment of moderate-severe plaque psoriasis - treatment of psoriatic arthritis [5,6] Contraindications: - pneumonitis Dosage: - start 100 mg SQ at 0 & 4 weeks, then - 100 mg SQ every 8 weeks Adverse effects: - no unexpected safety findings through 2 years [6] Mechanism of action: - IL23 inhibitor - human monoclonal IgG1-lambda - binds to the p19 subunit of IL-23 Management: - whenever possible bring patients up to date on vaccinations prior to initiating biologic immunosuppressive agent [7]

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. Brooks M FDA OKs Biologic Guselkumab (Tremfya) for Plaque Psoriasis Medscape. July 14, 2017 http://www.medscape.com/viewarticle/882947 - Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
  2. From The Medical Letter on Drugs and Therapeutics Guselkumab (Tremfya) for Psoriasis JAMA. 2017;318(24):2487-2488 PMID: 29279926 https://jamanetwork.com/journals/jama/article-abstract/2667061
  3. Puig L, Augustin M, Blauvelt A et al Effect of secukinumab on quality of life and psoriasis-related symptoms: a comparative analysis versus ustekinumab from the CLEAR 52-week study. J Am Acad Dermatol. 2017 Oct 21. pii: S0190-9622(17)32581-1. PMID: 29066271
  4. Langley RG, Tsai TF, Flavin S et al Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol. 2017 Jun 21. [Epub ahead of print] PMID: 28635018
  5. Mease PJ, Rahman P, Gottlieb AB et al Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020 Apr 4;395(10230):1126-1136 PMID: 32178766 - Deodhar A, Helliwell PS, Boehncke WH et al Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNF-alpha inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020 Apr 4;395(10230):1115-1125 PMID: 32178765
  6. Harris S Iain McInnes, FRCP, PhD, on the Long-Term Efficacy of Guselkumab in Patients With Psoriatic Arthritis. Efficacy maintained over 100 weeks, benefit-safety ratio favorable. MedPage Today January 14, 2022 https://www.medpagetoday.com/reading-room/acrr/psoriaticarthritis/96670 - McInnes IB, Rahman P, Gottlieb AB. Long-term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin-23, Through 2 Years: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Conducted in Biologic-naive Patients with Active Psoriatic Arthritis. Arthritis Rheumatol. 2021. Nov. 1 PMID: 34719872 https://onlinelibrary.wiley.com/doi/10.1002/art.42010
  7. Medical Knowledge Self Assessment Program (MKSAP) 19 American College of Physicians, Philadelphia 2022