March 2024

Long term safety of ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: A post hoc analysis of final safety data from 25 randomized clinical trials

Arthritis Res Ther 2024;26(1):49 doi: 10.1186/s13075-023-03257-7

Incident rates of TEAEs were comparable for patients with PsO, PsA, and axSpA and did not increase with prolonged ixekizumab (IXE) treatment. Deodhar, et al. presented the final update on the long-term safety of IXE up to 6 years in PsO patients and up to 3 years in PsA and axSpA patients. Exposure-adjusted incident rates were calculated using patient data (TEAEs, SAEs, selected AEs) from 25 clinical trials.

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Continuous improvement through differential trajectories of individual minimal disease activity criteria with guselkumab in active psoriatic arthritis: post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study

BMC Rheumatol. 2024 Feb 4;8(1):6 doi: 10.1186/s41927-024-00375-w

Increasing proportions of guselkumab-randomized patients met MDA domain criteria through
Week 100.

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February 2024

Modulation of IL-23 Signalling with Guselkumab in Biologic-Naïve Patients Versus TNF Inhibitor-Inadequate Responders with Active Psoriatic Arthritis

Arthritis Rheumatol 2024 doi 10.1002/art.42803 Epub ahead of print

Guselkumab treatment exhibited generally comparable and significant pharmacodynamic effects on IL-23/Th17–associated cytokines across participants with PsA who are biologic-naïve or have TNFi-IR. In coming to this conclusion, investigators assessed and compared immunologic differences and associations with clinical response to guselkumab in participants with active PsA who were biologic-naïve or TNFi-IR.

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November 2023

Segurança a longo prazo de Guselkumabe em pacientes com doença psoriática: Uma análise integrada de onze estudos clínicos de fase II/III em psoríase e artrite psoriática

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

Long-Term Safety and Efficacy of Ixekizumab in Patients with Axial Spondyloarthritis: 3-year Data from the COAST Program

J Rheumatol. 2023;50(8):1020–1028 doi: 10.3899/jrheum.221022

Three-year data from the ixekizumab (IXE) COAST programme provide additional evidence that patients with axSpA receiving IXE experience long-term safety, and sustained improvements in efficacy outcomes, at 3 years.

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April 2023

Guselkumab, um inibidor seletivo da subunidade p19 da interleucina-23, resolve a dactilite em pacientes com artrite psoriásica ativa: Resultados agrupados até a semana 52 de dois estudos 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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March 2023

Baixas Taxas de Progressão Radiográfica Associadas com Eficácia Clínica em até 2 anos de Seguimento Após Tratamento com Guselkumab: Resultados de um Ensaio Clínico Randomizado de Fase 3, Duplo-Cego, Controlado com Placebo com Pacientes Naïve a Biológicos com Artrite Psoriásica Ativa

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

O Efeito de Guselkumabe na Inibição Radiográfica em Pacientes com Artrite Psoriásica Ativa: protocolo do estudo APEX, um ensaio de fase 3b, multicêntrico, randomizado, duplo-cego, controlado com 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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October 2022

Recapture and Retreatment Rates with Ixekizumab After Withdrawal of Therapy in Patients with Axial Spondyloarthritis: Results at Week 104 From a Randomised Placebo-controlled Withdrawal Study

Ann Rheum Dis. 2022 doi: 10.1136/ard-2022-222731

The present analysis demonstrated that patients continuously treated with IXE were less likely to experience flare compared with patients receiving placebo. The aim of this study was to evaluate the recapture of response with open-label IXE retreatment at week 104 in patients with axSpA who flared after withdrawal of IXE therapy.

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September 2022

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.

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