guselkumab (Tremfya)
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Indications
- treatment of moderate-severe plaque psoriasis
- treatment of psoriatic arthritis[5][6]
- Crohn's disease[8]
Contraindications
Dosage
- start 100 mg SQ at 0 & 4 weeks, then
- 100 mg SQ every 8 weeks
- Crohn's disease
- 200 mg intravenous infusion weeks 0, 4, & 8, then 100-200 mg subcutaneous guselkumab every 4-8 weeks[9]
Adverse effects
- no unexpected safety findings through 2 years[6]
- drug adverse effects of immunosuppressive agents
- drug adverse effects of biologic immunosuppressive agents
- drug adverse effects of pharmaceutical monoclonal antibodies
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]
More general terms
References
- ↑ 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 - ↑ From The Medical Letter on Drugs and Therapeutics Guselkumab (Tremfya) for Psoriasis JAMA. 2017;318(24):2487-2488 PMID: https://pubmed.ncbi.nlm.nih.gov/29279926 https://jamanetwork.com/journals/jama/article-abstract/2667061
- ↑ 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: https://pubmed.ncbi.nlm.nih.gov/29066271
- ↑ 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: https://pubmed.ncbi.nlm.nih.gov/28635018
- ↑ 5.0 5.1 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: https://pubmed.ncbi.nlm.nih.gov/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: https://pubmed.ncbi.nlm.nih.gov/32178765 - ↑ 6.0 6.1 6.2 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: https://pubmed.ncbi.nlm.nih.gov/34719872 https://onlinelibrary.wiley.com/doi/10.1002/art.42010 - ↑ 7.0 7.1 Medical Knowledge Self Assessment Program (MKSAP) 19 American College of Physicians, Philadelphia 2022
- ↑ 8.0 8.1 Campbell P, Brooks A. FDA Approves Guselkumab (Tremfya) For Crohn Disease. HCPLive. March 20, 2025 https://www.hcplive.com/view/fda-approves-guselkumab-tremfya-for-crohn-disease
- ↑ 9.0 9.1 Panaccione R, Feagan BG, Afzali A et al Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025 Jul 17:S0140-6736(25)00681-6. PMID: https://pubmed.ncbi.nlm.nih.gov/40684778 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00681-6/abstract