November 2023

Risk of Major Adverse Cardiovascular Events in Immune-Mediated Inflammatory Disorders on Biologics and Small Molecules: Network Meta-Analysis

CClin Gastroenterol Hepatol 2023;22:961-970.e12

The results of this study show that anti-IL-12/23, JAK inhibitors, and anti-TNF-α were associated with slightly higher risk of MACE compared with placebo. The risk was no different between biologic treatments, and the magnitude of risk did not differ between IMID type.

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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

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

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

Guselkumab, un inhibidor selectivo de la subunidad p19 de la Interleukina-23, resuelve la dactilitis en pacientes con artritis psoriásica activa: resultados agrupados a lo largo de 52 semanas desde dos estudios de fase 3

ACR Open Rheumatol. 2023;5(4):227–240 doi 10.1002/acr2.11537

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.

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Eficacia y Seguridad Multidominios de Guselkumab a lo largo de 1 Año en Pacientes con Artritis Psoriásica Activa con y sin Exposición a Inhibidores del Factor de Necrosis Tumoral: Análisis del Ensayo de Fase 3, Aleatorizado, Controlado con Placebo DISCOVER-1

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.

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March 2023

Bajas Tasas de Progresión Radiográfica Asociadas con Eficacia Clínica Siguiendo hasta 2 Años de Tratamiento con Guselkumab: Resultados de un Ensayo Clínico Aleatorizado de Fase 3, Doble Ciego, Controlado con Placebo con Pacientes Naïve de Biológicos con Artritis Psoriasica Activa

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.

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February 2023

El efecto de Guselkumab en la Inhibición Radiográfica en Pacientes con Artritis Psoriásica Activa: Protocolo del Estudio APEX, un ensayo de Fase 3b, Multicéntrico, Aleatorizado, Doble-ciego, Controlado con Placebo

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.

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