September 2025

Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: Results through Week 24 of the Phase 3b, randomised, double-blind, placebo-controlled APEX study

Ann Rheum Dis 2025;0:1−12 Doi: 10.1016/j.ard.2025.08.006

Mease et al. showed that guselkumab provided significantly higher rates of clinical improvement and significant inhibition of structural damage progression versus PBO, with no new safety signals, at Week 24 in biologic-naïve participants with active and erosive PsA. Mease et al. report primary efficacy and safety results for the double-blind PBO-controlled phase (Weeks 0-24) of the 3-year APEX study.

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Impact of dactylitis and enthesitis resolution on disease control in guselkumab-treated psoriatic arthritis patients with TNFi-IR: COSMOS post hoc analysis

Rheumatology 2025;00:1–10 Doi: 10.1093/rheumatology/keaf490

Marzo-Ortega et al. report that dactylitis and enthesitis are associated with a greater disease burden and worse prognosis, highlighting the importance for physicians to identify these conditions and provide adequate treatment. Authors evaluated guselkumab’s efficacy on dactylitis resolution (DR) and enthesitis resolution (ER), and their impact on subsequent disease control, in patients with active PsA and prior inadequate response to tumour necrosis factor inhibitors (TNFi-IR).

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August 2025

Efficacy and safety of guselkumab subcutaneous induction and maintenance in participants with moderately to severely active Crohn’s disease: Results from the Phase 3 GRAVITI study

Gastroenterology 2025;169:308–25 Doi: 10.1053/j.gastro.2025.02.033

Results from the Phase 3 GRAVTI study by Hart et al. showed that SC induction followed by SC maintenance treatment with guselkumab resulted in superior clinical and endoscopic improvements in participants with moderately to severely active CD through 48 weeks compared with placebo. Hart et al. evaluated efficacy and safety of guselkumab SC induction followed by SC maintenance in participants with moderately to severely active CD in a    treat-through design.

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A long-term real-world safety study of guselkumab in patients with psoriasis who have infectious comorbidities, malignancies or heart disease: the EARLY study

Clin Exp Dermatol 2025;50:1786–1794 Doi: 10.1093/ced/llaf172

This study by Mortato et al. enhanced the limited safety data on guselkumab in patients with moderate-to-severe plaque psoriasis who have clinically relevant infectious and oncological comorbidities as well as concomitant heart disease. Authors assessed clinical outcomes and safety of guselkumab in a large cohort of patients with concomitant chronic infection, cancer or heart disease over a long follow-up period, addressing critical gaps in clinical evidence.

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March 2025

Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomised placebo-controlled PROTOSTAR study

Br J Dermatol 2025;192:618–628 doi: 10.1093/bjd/ljae502

Prajapati et al. conducted the PROTOSTAR trial to assess guselkumab in paediatric patients with moderate-to-severe plaque psoriasis. Guselkumab significantly improved skin clearance versus placebo at Wk16, with high response rates sustained through Wk52 and a favourable safety profile.

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December 2024

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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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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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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June 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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