January 2025

Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat through study

Lancet 2024;404:2423–36 doi: 10.1016/S0140-6736(24)01762-8

Ferrante et al. conducted a phase 3 trial evaluating the efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease. The study demonstrated that mirikizumab significantly improved clinical and endoscopic outcomes compared with placebo at week 52, with a favourable safety profile and tolerable adverse events.

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Sustained response to guselkumab regardless of baseline characteristics in patients with active psoriatic arthritis and inadequate response to TNF inhibitors: results from the phase 3b COSMOS clinical trial

RMD Open. 2024 Dec 12;10(4):e004494. doi: 10.1136/rmdopen-2024-004494.

McInnes et al. assessed the efficacy of guselkumab over 48 weeks in patients with psoriatic arthritis who had an inadequate response to TNF inhibitors. The results demonstrated consistent improvements in joint, skin, and patient-reported outcomes across all baseline-defined subgroups. Guselkumab showed greater efficacy compared with placebo at Week 24, with responses maintained or improved through Week 48.

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November 2024

Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: post hoc analysis of a 2-year, Phase 3, randomized, controlled study

ACR Open Rheumatol. 2024 doi 10.1002/acr2.11732 Epub ahead of print

Mease et al. conducted a post-hoc analysis of the phase 3 DISCOVER-2 trial to assess the persistence of clinically relevant improvements with guselkumab in biologic-naïve patients with PsA. The analysis showed that guselkumab maintained clinical improvements in joint and skin domains at consecutive dosing visits (Q8W) and over time.

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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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