Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2*

Reich, Kristian; Gordon, Kenneth B.; Strober, Bruce; Armstrong, April W.; Miller, Megan; Shen, Yaung‐Kaung; Yin, You; Han, Chenglong; Yang, Ya‐Wen; Foley, Peter; Griffiths, Chris

doi:10.1111/bjd.20568

Cited by 48 publications

(41 citation statements)

References 27 publications

(45 reference statements)

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“…Treatment effect was maintained through up to 2 years in DISCOVER-2 12. Adverse events were generally consistent with those seen in patients with PsO receiving guselkumab 100 mg Q8W for up to 5 years 13 14…”

Section: Introductionsupporting

confidence: 58%

Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies

et al. 2022

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ObjectivesTo evaluate the efficacy through 52 weeks of guselkumab, an interleukin 23-p19 subunit inhibitor, in subgroups of pooled psoriatic arthritis (PsA) patients from the DISCOVER-1 and DISCOVER-2 trials defined by baseline patient characteristics.MethodsAdults with active PsA despite standard therapies were enrolled in DISCOVER-1 (≥3 swollen and ≥3 tender joints, C reactive protein (CRP) level ≥0.3 mg/dL) and DISCOVER-2 (≥5 swollen and ≥5 tender joints, CRP ≥0.6 mg/dL, biological-naïve). Randomised patients received 100 mg guselkumab at weeks 0, 4, and then every 4 or 8 weeks (Q4W/Q8W) or placebo. Guselkumab effects on joint (ACR20/50/70), skin (IGA 0/1, IGA 0), patient-reported outcome (Health Assessment Questionnaire Disability Index/Functional Assessment of Chronic Illness Therapy-Fatigue) and disease severity (minimal disease activity/PsA Disease Activity Score low disease activity) endpoints were evaluated by patient sex, body mass index, PsA duration, swollen/tender joint counts, CRP level, percent body surface area with psoriasis, Psoriasis Area and Severity Index score, and conventional synthetic disease-modifying antirheumatic drug use at baseline.ResultsBaseline patients characteristics in DISCOVER-1 (N=381) and DISCOVER-2 (N=739) were well balanced across randomised groups. At week 24, 62% (232/373) and 60% (225/375), respectively, of guselkumab Q4W-treated and Q8W-treated patients pooled across DISCOVER-1 and DISCOVER-2 achieved the primary endpoint of ACR20 response versus 29% (109/372) of placebo-treated patients. Guselkumab treatment effect at week 24 was observed across patient subgroups. Within each patient subgroup, response rates across all disease domains were sustained or increased at week 52 with both guselkumab regimens.ConclusionsGuselkumab Q4W and Q8W resulted in robust and sustained improvements in PsA signs and symptoms consistently in subgroups of patients defined by diverse baseline characteristics.Trial registration numbersNCT03162796, NCT03158285.

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Section: Introductionsupporting

confidence: 58%

Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies

et al. 2022

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“… 22 Finally, at week 204 PASI 90 was reached by 84.1% and 82.0% of patients in VOYAGE 1 and VOYAGE 2, respectively, with 82.4% and 85.0% reaching IGA 0/1. 23 …”

Section: Discussionmentioning

confidence: 99%

Long-Term Efficacy and Safety of Guselkumab for Moderate to Severe Psoriasis: A 3-Year Real-Life Retrospective Study

Megna¹,

Potestio²,

Fabbrocini³

et al. 2022

PTT

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Introduction Guselkumab safety and efficacy profiles in psoriasis have been showed by VOYAGE (1 and 2) trials. Although trial results have been already previously confirmed by real-life studies, long-term real-life data, and drug survival data about guselkumab are still poor. Patients and Methods We performed a 3-year retrospective study, with the aim of assessing guselkumab efficacy and safety profile in the management of plaque psoriasis in a real-life setting. Results Thirty-one patients completed the study. Both Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) statistically improved since week 16, and up to week 144 [PASI reduction from 16.4 ± 6.2 to 0.6 ± 0.9 (p < 0.0001) at week 144 while BSA from 33.2 ± 14.6 to 1.9 ± 1.4 (p < 0.0001)]. At week 12 PASI90 and PASI100 were achieved by 19 (61.3%) and 11 (35.4%) patients, respectively, as well as 24 (77.4%) and 18 (58.1%) subjects reached PASI 90 and PASI 100 at week 144. As regards the safety, no cases of injection site reaction, candida, serious AEs, malignancy, or major cardiovascular events were reported. Of note, mild AEs were collected with pharyngitis as the main one (7, 22.6%), followed by headache (5, 16.1%) and flu-like illness (5, 16.1%), all without requiring treatment discontinuation. Conclusion Our experience confirmed the efficacy and safety of guselkumab in daily clinical practice up to 3 years, suggesting this drug as an effective treatment option in psoriasis long-term management.

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“…These results have been maintained for 5 years so far. 12 A different scenario is seen in real clinical practice where most patients switch from anti-TNFα to GUS due to inefficacy or AE. Some RWE studies reported the use of GUS in patients who failed anti-TNFα (including biosimilars) together with patients who failed other biological therapies.…”

Section: Previous Anti-tnfαmentioning

confidence: 99%

Guselkumab as a switching strategy after anti‐TNFα , anti‐IL17 , or anti‐IL12 /23 therapies in moderate‐to‐severe psoriasis

Ruiz‐Villaverde

Rodriguez‐Fernandez‐Freire

Armario‐Hita

et al. 2022

Dermatologic Therapy

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The IL23/Th17 axis plays a strategic role in psoriasis (PSO). Guselkumab (GUS) is a selective inhibitor of the IL23p19 subunit. Its introduction has managed to increase the levels of efficacy, safety and survival in PSO. In real clinical practice, patients can loss effectiveness or suffered adverse events that forces a change in their treatments. There is scarce evidence of the effectiveness, safety, and survival of GUS in real clinical practice after anti-TNFα, anti-IL17, and/or anti-IL12/23. This is multicenter, observational and retrospective study of real clinical practice includes patients with moderate-to-severe plaque

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Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2*

Cited by 48 publications

References 27 publications

Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies

Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies

Long-Term Efficacy and Safety of Guselkumab for Moderate to Severe Psoriasis: A 3-Year Real-Life Retrospective Study

Guselkumab as a switching strategy after anti‐TNFα , anti‐IL17 , or anti‐IL12 /23 therapies in moderate‐to‐severe psoriasis

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