guselkumab

Guselkumab is indicated to treat plaque psoriasis, psoriatic arthritis, and ulcerative colitis.{{cite web | title=Tremfya- guselkumab injection | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56 | access-date=22 January 2021}}

Guselkumab lowers the release of immune system signalling molecules, increasing the risk of infections from bacteria, viruses, and fungi.

The most common side effects for guselkumab are upper respiratory tract infections, headache, injection site reactions,{{cite journal | vauthors = Kim PJ, Lansang RP, Vender R | title = A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections | journal = Journal of Cutaneous Medicine and Surgery | volume = 27 | issue = 4 | pages = 358–367 | date = July 2023 | pmid = 37533141 | doi = 10.1177/12034754231188444 | pmc = 10486173 }} joint pain, diarrhea, gastroenteritis, fungal skin infections and herpes simplex infections.{{cite web | url = https://www.fda.gov/Drugs/InformationOnDrugs/ucm568274.htm | archive-url = https://web.archive.org/web/20171102185444/https://www.fda.gov/Drugs/InformationOnDrugs/ucm568274.htm | url-status = dead | archive-date = 2 November 2017 | date = 3 August 2017 | work = Drug Approvals and Databases > Drug Trials Snapshots | title = TREMFYA | publisher = U.S. Food and Drug Administration }}

Guselkumab targets the IL-23 subunit alpha (p19 subunit){{cite journal | vauthors = Oppmann B, Lesley R, Blom B, Timans JC, Xu Y, Hunte B, Vega F, Yu N, Wang J, Singh K, Zonin F, Vaisberg E, Churakova T, Liu M, Gorman D, Wagner J, Zurawski S, Liu Y, Abrams JS, Moore KW, Rennick D, de Waal-Malefyt R, Hannum C, Bazan JF, Kastelein RA | display-authors = 6 | title = Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12 | journal = Immunity | volume = 13 | issue = 5 | pages = 715–725 | date = November 2000 | pmid = 11114383 | doi = 10.1016/S1074-7613(00)00070-4 | doi-access = free }} preventing it from binding to cell receptors that would otherwise be activated by its presence.

• C_max 8.09 μg/mL
• t_max 5.5 days
• volume of distribution 13.5 L
• apparent clearance 0.516 L/day

Guselkumab was developed by Janssen Pharmaceuticals.{{cite web | url = http://www.genengnews.com/gen-news-highlights/janssen-wins-fda-approval-for-plaque-psoriasis-treatment-tremfya/81254657 | title = Janssen Wins FDA Approval for Plaque Psoriasis Treatment Tremfya | date = 14 July 2017 | work = Genetic Engineering & Biotechnology News }} In November 2016, Janssen submitted a Biologics License Application (BLA) to the FDA seeking approval of guselkumab.{{cite press release | url = https://www.jnj.com/media-center/press-releases/janssen-submits-application-to-ema-seeking-approval-of-anti-interleukin-23-monoclonal-antibody-guselkumab-for-the-treatment-of-moderate-to-severe-plaque-psoriasis | title = Janssen Submits Application to EMA Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab for the Treatment of Moderate-to-Severe Plaque Psoriasis | publisher = Janssen | access-date = 1 November 2017 | archive-date = 7 November 2017 | archive-url = https://web.archive.org/web/20171107012828/http://www.janssen.com/janssen-submits-application-ema-seeking-approval-anti-interleukin-23-monoclonal-antibody-guselkumab }}

In July 2017, the US Food and Drug Administration (FDA) approved guselkumab for the treatment of plaque psoriasis.{{cite web | url = https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm537040.htm | archive-url = https://web.archive.org/web/20170201030649/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm | url-status = dead | archive-date = 1 February 2017 | title = Novel Drug Approvals for 2017 | date = 25 January 2021 | publisher = U.S. Food and Drug Administration (FDA) }}

In November 2017, Health Canada approved guselkumab for the treatment of plaque psoriasis.{{cite web | title=Regulatory Decision Summary for Tremfya | website=Drug and Health Products Portal | date=2017-11-10 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00308 | access-date=2024-03-18}} In September 2020, the approval was expanded to include the treatment of adults with psoriatic arthritis.{{cite web | title=Regulatory Decision Summary for Tremfya | website=Drug and Health Products Portal | date=2020-09-04 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00697 | access-date=2024-03-18}}

In April 2018, guselkumab was approved in Japan for the treatment of psoriatic arthritis.{{Cite web|url=http://pharmabiz.com/NewsDetails.aspx?aid=108225&sid=2|title=MorphoSys' licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis|website=pharmabiz.com|access-date=5 June 2018|archive-date=29 April 2021|archive-url=https://web.archive.org/web/20210429085241/http://pharmabiz.com/NewsDetails.aspx?aid=108225&sid=2|url-status=dead}}

In July 2020, the FDA approved guselkumab as the first IL-23 inhibitor to treat active psoriatic arthritis (PsA).{{Cite web|title=FDA approves Tremfya (guselkumab) for psoriatic arthritis|url=https://www.mdedge.com/rheumatology/article/225460/psoriatic-arthritis/fda-approves-tremfya-guselkumab-psoriatic-arthritis|access-date=15 July 2020|website=www.mdedge.com}}{{Cite news|date=14 July 2020|title=DGAP-News: MororphoSys's Licensee Janssen Announces Approval of Tremfya (Guselkumab) by U.S. FDA for Treatment of Adults with Active Psoriatic Arthritis|work=Bloomberg.com|url=https://www.bloomberg.com/press-releases/2020-07-14/dgap-news-mororphosys-s-licensee-janssen-announces-approval-of-tremfya-guselkumab-by-u-s-fda-for-treatment-of-adults-with|access-date=6 September 2020}}

In September 2024, the FDA approved guselkumab for the treatment of moderately to severely active ulcerative colitis in adults.{{cite press release | url=https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-receives-u-s-fda-approval-for-adults-with-moderately-to-severely-active-ulcerative-colitis-strengthening-johnson-johnsons-leadership-in-inflammatory-bowel-disease | title = 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 | publisher = Johnson & Johnson }}

In May 2025, Johnson & Johnson (J&J) received approval from the EU's Medicines and Healthcare products Regulatory Agency (MHRA) for the use of guselkumab in Crohn’s disease and ulcerative colitis.

The list price of each 100 mg dose is about {{US$|10,000}}.{{cite web | vauthors = Helfand C | date = 13 July 2017 | title = Johnson & Johnson's Tremfya gets its go-ahead to fight Novartis, Lilly in psoriasis. Can it stand out? | url = http://www.fiercepharma.com/pharma/johnson-johnson-s-tremfya-gets-its-green-light-to-challenge-novartis-lilly-and-more-ultra | work = Fierce Pharma }}

During development, guselkumab was referred to as CNTO-1959.

Guselkumab has undergone phase 3 clinical trials comparing it with adalimumab (Humira) and ustekinumab (Stelara).

The safety and efficacy of guselkumab was compared to a placebo and to adalimumab in the "VOYAGE 1" and "VOYAGE 2" phase 3 clinical trials (ClinicalTrials.gov IDs: NCT02207231 and NCT02207244).{{cite journal | vauthors = Nakamura M, Lee K, Jeon C, Sekhon S, Afifi L, Yan D, Lee K, Bhutani T | display-authors = 6 | title = Guselkumab for the Treatment of Psoriasis: A Review of Phase III Trials | journal = Dermatology and Therapy | volume = 7 | issue = 3 | pages = 281–292 | date = September 2017 | pmid = 28639011 | pmc = 5574739 | doi = 10.1007/s13555-017-0187-0 }} Preliminary results indicated that a significantly higher proportion of patients taking guselkumab had better skin clearance compared to those taking the other treatments. At week 16, 73.3% of patients taking guselkumab achieved a 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.

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.{{cite journal | vauthors = Markham A | title = Guselkumab: First Global Approval | journal = Drugs | volume = 77 | issue = 13 | pages = 1487–1492 | date = September 2017 | pmid = 28819723 | doi = 10.1007/s40265-017-0800-7 | s2cid = 35810454 }}{{Cite report |url=https://clinicaltrials.gov/study/NCT02203032 |title=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 |last=Janssen Research & Development, LLC |date=2017-08-11 |publisher=clinicaltrials.gov |issue=NCT02203032}}

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Category:Anti-interleukin monoclonal antibodies

Category:Drugs developed by Johnson & Johnson