Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
Drug Saf. 2023 doi:10.1007/s40264-023-01361-w. Epub ahead of print
Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.
Guselkumab, a Selective Interleukin-23 p19 Subunit Inhibitor, Resolves Dactylitis in Patients With Active Psoriatic Arthritis: Pooled Results Through Week 52 From Two Phase 3 Studies
ACR Open Rheumatol. 2023 doi 10.1002/acr2.11537 Epub ahead of print
Post hoc analysis of guselkumab, Phase 3 DISCOVER-1 and -2 studies finds that 75% of guselkumab-randomised patients have complete resolution of dactylitis through one year.
Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients with Active Psoriatic Arthritis with and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo-Controlled DISCOVER-1 Study
ACR Open Rheumatol. 2023 doi: 10.1002/acr2.11523
TNF inhibitors (TNFi) are one main mode of therapy in patients with PsA who fail to respond to csDMARDs. However, they have a primary treatment failure rate of 40% and only a modest target of ≥20% ACR20 response. The objective of this study was to evaluate efficacy and safety of guselkumab, interleukin-23 inhibitor in the DISCOVER-1 study with active PsA patients by prior use of TNFi.
Low Rates of Radiographic Progression Associated with Clinical Efficacy Following up to 2 Years of Treatment with Guselkumab: Results From a Phase 3, Randomised, Double-blind, Placebo-controlled Study of Biologic-naïve Patients with Active Psoriatic Arthritis
RMD Open. 2023 doi: 10.1136/rmdopen-2022-002789
Data from this paper provides a robust analysis of radiographic progression through 2 years in a phase 3 study of guselkumab in patients with PsA. This study sought to evaluate the relationship between radiographic progression and clinical outcomes in post hoc analyses of patients with PsA receiving up to 2 years of guselkumab therapy in DISCOVER-2.
The Effect of Guselkumab on Inhibiting Radiographic Progression in Patients with Active Psoriatic Arthritis: Study Protocol for APEX, a Phase 3b, Multicenter, Randomized, Double‑blind, Placebo‑controlled Trial
Trials. 2023 doi: 10.1186/s13063-022-06945-y
Guselkumab was approved for treating the signs and symptoms of active PsA following two Phase 3 global studies, DISCOVER-1 and DISCOVER-2. The Phase 3b APEX study has been designed to address the limitations of DISCOVER-2 and further assess the effects of guselkumab Q4W and Q8W on PsA outcomes.
Safety of Guselkumab with and without Prior TNF-α Inhibitor Treatment: Pooled Results Across Four Studies in Patients with Psoriatic Arthritis
J Rheumatol. 2023 jrheum
These results demonstrate that guselkumab was well tolerated in studies continuing for 1 to 2 years among patients with moderate-to-severe PsA regardless of TNFi experience and concomitant MTX use. The objective of this study was to assess pooled safety results from Phase 2/3 studies of guselkumab in TNFi-naïve and experienced PsA patients.
The Effect of Guselkumab on General Health State in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial
Adv Ther. 2022 Oct;39(10):4632-4644 doi: 10.1007/s12325-022-02269-0
In the latest study by Curtis, et al. guselkumab treatment regimens improved general HRQoL as measured by the EQ-5D-5L Index and EQ-VAS. In reaching this conclusion investigators aimed to determine the minimal important difference for both instruments and to understand the associations between patient-reported EQ-5D-5L Index and EQ-VAS scores as well as key PsA clinical features.
Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis
Rheumatology (Oxford) 2022 doi: 10.1093/rheumatology/keac375
This analysis found that patients with active PsA who receive treatment with guselkumab can achieve robust and sustained low disease activity or remission. In reaching this conclusion investigators sought to evaluate the efficacy of guselkumab for the treatment of active PsA through the use of composite indices.