Drug updated on 5/17/2024
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
- Guselkumab (Tremfya) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis and active psoriatic arthritis. It targets the interleukin-23 pathway, which plays a crucial role in psoriatic disease pathogenesis.
- The information about this drug was derived from 17 systematic reviews/meta-analyses documents that provide comprehensive analysis regarding its safety and effectiveness compared to other systemic therapies and biologics.
- In terms of skin efficacy, guselkumab has been highlighted for superior performance in achieving high Psoriasis Area and Severity Index responses, particularly PASI 90, compared to many other agents including TNF inhibitors and JAK inhibitors.
- For arthritic efficacy in PsA cases, guselkumab demonstrated comparable American College of Rheumatology response rates to other biologics such as IL-17 inhibitors and TNF inhibitors.
- Relative to other biologics/systemic therapies used for treating these conditions, guselkumab showed a similar rate of serious adverse events, presenting an overall favorable safety profile without significant increase in risk factors like serious infections.
- Subgroup considerations reveal robust utility across various patient scenarios ranging from those previously untreated or those who had an inadequate response to prior treatments including different types of biologic drugs like ustekinumab.
- The long-term analyses show sustained PASI responses over periods extending up to 48 weeks or more, along with stable safety profiles, indicating its suitability for long-term management plans.
- In comparison studies against newer/older biologicals, guselkumab often ranks similarly on both efficacy and safety parameters, especially over longer durations, even though some IL-17 inhibitors may demonstrate slight superiority at certain endpoints.
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 |