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SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- Please refer to the local labeling for relevant information on dosage and administration of TREMFYA.
- The 2 phase 3 (DISCOVER-1 and DISCOVER-2) and the phase 3b (COSMOS) clinical trials that evaluated the efficacy and safety of TREMFYA in the treatment of active psoriatic arthritis (PsA) did not evaluate retreatment after a drug free interval.1-3
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and Derwent® (and/or other resources, including internal/external databases) conducted on 11 June 2024 did not identify any relevant literature pertaining to this topic.
1 | Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial [published correction appears in Lancet. 2020 Apr 4;395(10230):1114. Lancet. 2020;395(10230):1115-1125. |
2 | Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial [published correction appears in Lancet. 2020 Apr 4;395(10230):1114. Lancet. 2020;395(10230):1126-1136. |
3 | Coates LC, Gossec L, Theander E, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who demonstrated inadequate response to tumor necrosis factor inhibition: results of a phase 3b, randomized, controlled study. Oral Presentation presented at: European League Against Rheumatism (EULAR); June 2-5, 2021; Virtual Congress. |