Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 100 mg/mL) |
Drug Class | Interleukin-23 blockers |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Indicated for the treatment of adult patients of active psoriatic arthritis.
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Summary
- Tremfya (guselkumab) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and for the treatment of adult patients with active psoriatic arthritis.
- This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
- Guselkumab (100 mg Q8W) showed comparable ACR 20, 50, and 70 response rates to IL-17A inhibitors and subcutaneous TNF inhibitors, with significant improvement in ACR20 response compared to placebo.
- Guselkumab demonstrated superior PASI 75, 90, and 100 responses compared to placebo and adalimumab, and was among the top-performing drugs for PASI responses, comparable to risankizumab, brodalumab, and ixekizumab for PASI 100.
- Guselkumab Q8W was effective in improving the modified van der Heijde-Sharp (vdH-S) score, showing similar effectiveness to risankizumab and superior to most other agents, except intravenous TNF therapies.
- Guselkumab showed high efficacy in resolving enthesitis and dactylitis, comparable to IL-17A and IL-17RA inhibitors, and demonstrated high effectiveness in achieving clear or almost clear skin (PASI 90).
- Guselkumab had a similar incidence of adverse events compared to placebo and adalimumab, with lower rates of adverse events compared to brodalumab and ixekizumab. The rates of adverse events leading to treatment discontinuation were low.
- No statistical difference in serious adverse events was observed between guselkumab and placebo, with a comparable rate of serious adverse events to most other agents. Some reports indicated a higher rate of elevated transaminases compared to placebo.
- Guselkumab showed no significant association with infections or serious infections compared to placebo or adalimumab. Elevated transaminases were noted as a specific safety concern.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tremfya (guselkumab) Prescribing Information. | 2023 | Janssen Biotech, Inc., Horsham, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Japanese guidance for use of biologics for psoriasis (the 2019 version). | 2019 | The Journal of Dermatology |
Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. | 2019 | Journal of the American Academy of Dermatology |