July 2024

Guselkumab demonstrates long-term efficacy and maintenance of treatment response postwithdrawal in systemic treatment-naïve patients and nonresponders to fumaric acid esters: Results from parts II and III of a randomized active-comparator-controlled Phase IIIb trial (POLARIS)

Br J Dermatol 2024;191:36–48 doi: 10.1093/bjd/ljad523

Thaçi, et al. show that guselkumab (GUS) had higher efficacy and a more tolerable safety profile compared with fumaric acid esters (FAE) in patients with moderate. Long-term efficacy through 100 weeks of treatment was seen with GUS as a first-line systemic treatment, and as a second-line systemic treatment in FAE nonresponders.

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Durable Control of Psoriatic Arthritis with Guselkumab Across Domains and Patient Characteristics: Post Hoc Analysis of a Phase 3 study

Clin Rheumatol 2024 doi: 10.1007/s10067-024-06991-8 Epub ahead of print

Ritchlin et al. conducted a post hoc analysis of the DISCOVER-2 trial, evaluating the efficacy of guselkumab in biologic-naïve patients with PsA. Guselkumab provided durable disease control across key PsA domains and PROs over 2 years, regardless of baseline characteristics. A significant proportion of patients achieved stringent endpoints such as ACR50/70, complete skin clearance, and resolution of dactylitis/enthesitis.

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May 2024

Guselkumab for the Treatment of Crohn’s Disease: Induction Results From the Phase 2 GALAXI-1 Study

Gastroenterology 2023;165:1588 doi 10.1053/j.gastro.2022.01.047

Guselkumab induced greater clinical and endoscopic improvements in patients with Crohn’s disease versus placebo, with a favourable safety profile in this Phase 2 trial by Sandborn, et al.

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April 2024

Guselkumab provides durable improvement across psoriatic arthritis disease domains: Post hoc analysis of a Phase 3, randomised, double-blind, placebo-controlled study

RMD Open 2024;10:e003977 doi: 10.1136/rmdopen-2023-003977

Significant improvements in overall disease activity, enthesitis and dactylitis, and skin psoriasis were observed by Week 8 and maintained or improved through Week 100 in both guselkumab treatment groups. Coates et al conducted a post-hoc analysis of the Phase 3 DISCOVER-2 trial to investigate the long-term (100-week) efficacy of guselkumab across GRAPPA-identified PsA domains.

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Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the Phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial

J Am Acad Dermatol 2017;76:418–31. doi: 10.1016/j.jaad.2016.11.042

Patients treated with guselkumab showed an improved and sustained clinical response compared to both adalimumab and placebo, without compromising safety profile. The Phase 3 VOYAGE 2 trial by Reich et al focused on treatment interruption and withdrawal, as well as treatment switching from adalimumab to guselkumab.

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fficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the Phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial

J Am Acad Dermatol 2017;76:405–17. doi: 10.1016/j.jaad.2016.11.041

Guselkumab demonstrated superiority to adalimumab and placebo in treating PsO in this Phase 3 study. Improvements in IGA and PASI scores were observed as early as Week 16 and were maintained up to Week 48. Incidence of adverse events was similar across both treatment groups.

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March 2024

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

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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