What is the dosing regimen for Tremfya (guselkumab) in the treatment of psoriatic arthritis?

From the Guidelines

Tremfya (guselkumab) for psoriatic arthritis is administered as a 100 mg subcutaneous injection at weeks 0 and 4 (initial loading doses), followed by maintenance dosing of 100 mg every 8 weeks thereafter. The medication should be injected under the skin, typically in the thigh, abdomen, or upper arm. Patients or caregivers can administer the injection after proper training, and the prefilled syringe or autoinjector should be allowed to reach room temperature for 30 minutes before use. Tremfya works by selectively targeting the IL-23 cytokine pathway, which plays a key role in the inflammatory process of psoriatic arthritis. This targeted approach helps reduce joint inflammation, pain, and skin symptoms associated with the condition. Patients should maintain their regular dosing schedule for optimal results, and if a dose is missed, it should be administered as soon as possible, then resume the regular schedule. The medication should be stored in the refrigerator (36°F to 46°F/2°C to 8°C) and protected from light until ready for use, as indicated in the study 1.

Key Considerations

• The dosing regimen is based on the FDA-approved guidelines for the treatment of psoriatic arthritis with biologics, as outlined in the joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics 1.
• The European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies also support the use of biologics like Tremfya in the treatment of psoriatic arthritis, although they do not specify the exact dosing regimen 1.
• The American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis provides recommendations for switching between different biologics, including Tremfya, based on patient response and adverse effects 1.
• However, the most recent and highest-quality study, which is the joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics 1, provides the dosing regimen for Tremfya, which is the basis for the recommendation.

Administration and Storage

• Patients or caregivers should be properly trained to administer the injection.
• The prefilled syringe or autoinjector should be allowed to reach room temperature for 30 minutes before use.
• The medication should be stored in the refrigerator and protected from light until ready for use.

Monitoring and Adjustments

• Patients should be regularly monitored for response to treatment and potential adverse effects.
• The dosing schedule may need to be adjusted based on patient response and adverse effects, as indicated in the studies 1.

From the FDA Drug Label

2.3 Recommended Dosage for Psoriatic Arthritis TREMFYA is administered by subcutaneous injection. The recommended dosage is 100 mg at Week 0, Week 4, and every 8 weeks thereafter. TREMFYA may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).

The dosing regimen for Tremfya (guselkumab) in the treatment of psoriatic arthritis is 100 mg administered by subcutaneous injection at:

• Week 0
• Week 4
• And every 8 weeks thereafter. Tremfya may be used alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD), such as methotrexate 2.

From the Research

Tremfya Dosing for Psoriatic Arthritis

The dosing regimen for Tremfya (guselkumab) in the treatment of psoriatic arthritis is as follows:

• 100 mg at Week 0, Week 4, then every 8 weeks 3, 4
• Alternatively, 100 mg every 4 weeks 5, 6

Key Considerations

• The dosing regimen may vary depending on the specific patient population and study design 3, 5, 6
• Guselkumab has been shown to be effective and well-tolerated in patients with active psoriatic arthritis, with a favorable benefit-risk profile 5, 6, 7
• Real-world evidence suggests that guselkumab is associated with higher treatment persistence rates compared to subcutaneous tumor necrosis factor inhibitors 4

Study Findings

• The DISCOVER-1 and DISCOVER-2 studies demonstrated the efficacy and safety of guselkumab in patients with active psoriatic arthritis, with dosing regimens of 100 mg every 4 weeks or every 8 weeks 5, 6
• The phase 2 study of guselkumab in patients with active psoriatic arthritis showed significant improvements in signs and symptoms of psoriatic arthritis, with a dosing regimen of 100 mg at Week 0, Week 4, and every 8 weeks thereafter 7
• Real-world evidence from the IQVIA PharMetrics Plus database showed that guselkumab was associated with higher treatment persistence rates compared to subcutaneous tumor necrosis factor inhibitors, with a dosing regimen of 100 mg at Week 0, Week 4, then every 8 weeks 4