Publications

View and download slide summaries of the latest original articles focusing on therapies in immune-mediated inflammatory diseases including rheumatology, dermatology, and gastroenterology. All materials produced by the team are subsequently reviewed and approved by individual Steering Committee members.

November 2023

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;47(1)39–57 doi:10.1007/s40264-023-01361-w

Wang Y,

Li S,

Chakravarty SD,

Chan D,

Shawi M,

Yang YW,

Thaҫi D,

Rahman P.

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.

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September 2023

Guselkumab Modulates Differentially Expressed Genes in Blood of Patients with Psoriatic Arthritis: Results from Two Phase 3, Randomized, Placebo-Controlled Trials

ACR Open Rheumatol. 2023 doi: 10.1002/acr2.11589

Hsia EC,

Xu XL,

Song Q,

Gao S,

Chen W,

Miron M

Whole blood transcriptome profiling reveals differential gene expression in patients with active PsA from the DISCOVER-1 and DISCOVER-2 clinical studies in comparison with healthy controls.

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April 2023

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

Xu XL,

Shawi M,

Jiang Y,

Sheng S,

Helliwell PS

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.

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March 2023

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

Xu XL,

Jiang Y,

Sheng S,

Shawi M,

Chakravarty SD,

Lavie F,

Mease PJ

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.

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February 2023

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

Song J,

Jiang Y,

Shawi M,

Kollmeier AP,

Rahman P

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.