Guselkumab Pharmacology
Mechanism of action
Guselkumab targets the IL-23 subunit alpha (p19 subunit)[ 11] [ 12]
Pharmacokinetics
Cmax 8.09 μg/mL
tmax 5.5 days
volume of distribution 13.5 L
apparent clearance 0.516 L/day[ 12] Society and culture
Economics
The list price of each 100 mg dose is about US$10,000 .[ 22]
Names
During development, guselkumab was referred to as CNTO-1959.[ 12]
Research
Guselkumab has undergone phase III clinical trials comparing it with adalimumab (Humira) and ustekinumab (Stelara).[ 13]
The safety and efficacy of guselkumab was compared to a placebo and to adalimumab in the "VOYAGE 1" and "VOYAGE 2" phase III clinical trials (ClinicalTrials.gov IDs: NCT02207231 and NCT02207244).[ 23] PASI 90 (90% reduction in PASI score from baseline), vs 49.7% of those taking adalimumab; additionally, 91.2% of patients taking guselkumab achieved a PASI 75 (75% reduction in PASI score from baseline), vs 73.1% of those taking adalimumab.[ 23]
The phase III clinical trial "NAVIGATE" (ClinicalTrials.gov ID: NCT02203032) included only patients who had poor responses to treatment with ustekinumab. It showed that patients who switched to guselkumab from ustekinumab did better than those who remained on ustekinumab.[ 12] [ 24]
References
↑ "Tremfya (Guselkumab) Australian Product Information" . Department of Health, Therapeutic Goods Administration . The Australian Government.↑ "Product information" . Health Canada . Retrieved 18 March 2024 .↑ "Skin health" . Health Canada . Retrieved 13 April 2024 .↑ "Tremfya 100 mg solution for injection in pre-filled pen - Summary of Product Characteristics (SmPC)" . (emc) . 1 November 2020. Retrieved 12 June 2021 .1 2 3 "Tremfya- guselkumab injection" . DailyMed . Retrieved 22 January 2021 .1 2 3 "Tremfya EPAR" . European Medicines Agency {EMA). Retrieved 12 June 2021 .↑ "Guselkumab". LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet] . National Institute of Diabetes and Digestive and Kidney Diseases. June 2018. PMID 31643594 . 1 2 "Tremfya (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson's leadership in inflammatory bowel disease" (Press release). Johnson & Johnson.↑ Kim PJ, Lansang RP, Vender R (July 2023). "A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections" . Journal of Cutaneous Medicine and Surgery . 27 (4): 358– 367. doi :10.1177/12034754231188444 . PMC 10486173 PMID 37533141 . ↑ "Tremfya" . U.S. Food and Drug Administration (FDA). 3 August 2017. Archived from the original on 2 November 2017.↑ Oppmann B, Lesley R, Blom B, Timans JC, Xu Y, Hunte B, et al. (November 2000). "Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12" . Immunity . 13 (5): 715– 725. doi :10.1016/S1074-7613(00)00070-4 PMID 11114383 . {{cite journal }}: CS1 maint: overridden setting (link )1 2 3 4 Markham A (September 2017). "Guselkumab: First Global Approval". Drugs . 77 (13): 1487– 1492. doi :10.1007/s40265-017-0800-7 . PMID 28819723 . S2CID 35810454 . 1 2 "Janssen Wins FDA Approval for Plaque Psoriasis Treatment Tremfya" . Genetic Engineering & Biotechnology News . 14 July 2017.↑ "Janssen Submits Application to EMA Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab for the Treatment of Moderate-to-Severe Plaque Psoriasis" (Press release). Janssen. Archived from the original on 7 November 2017. Retrieved 1 November 2017 .↑ "Novel Drug Approvals for 2017" . U.S. Food and Drug Administration (FDA). 25 January 2021. Archived from the original on 1 February 2017.↑ "Regulatory Decision Summary for Tremfya" . Drug and Health Products Portal . 10 November 2017. Retrieved 18 March 2024 .↑ "Regulatory Decision Summary for Tremfya" . Drug and Health Products Portal . 4 September 2020. Retrieved 18 March 2024 .↑ "MorphoSys' licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis" . pharmabiz.com . Archived from the original on 29 April 2021. Retrieved 5 June 2018 .↑ "FDA approves Tremfya (guselkumab) for psoriatic arthritis" . www.mdedge.com . Retrieved 15 July 2020 .↑ "DGAP-News: MororphoSys's Licensee Janssen Announces Approval of Tremfya (Guselkumab) by U.S. FDA for Treatment of Adults with Active Psoriatic Arthritis" . Bloomberg.com . 14 July 2020. Retrieved 6 September 2020 .↑ "MHRA approves guselkumab for Crohn's disease and ulcerative colitis" . GOV.UK . 16 May 2025. Retrieved 4 October 2025 .↑ Helfand C (13 July 2017). "Johnson & Johnson's Tremfya gets its go-ahead to fight Novartis, Lilly in psoriasis. Can it stand out?" . Fierce Pharma . 1 2 Nakamura M, Lee K, Jeon C, Sekhon S, Afifi L, Yan D, et al. (September 2017). "Guselkumab for the Treatment of Psoriasis: A Review of Phase III Trials" . Dermatology and Therapy . 7 (3): 281– 292. doi :10.1007/s13555-017-0187-0 . PMC 5574739 PMID 28639011 . {{cite journal }}: CS1 maint: overridden setting (link )↑ Janssen Research & Development, LLC (11 August 2017). A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab (Report). clinicaltrials.gov.
Intracellular
Intracellular
Extracellular
Unsorted
