Early disease intervention with guselkumab in psoriasis leads to a higher rate of stable complete skin clearance ('clinical super response') : Week 28 results from the ongoing phase IIIb randomized, double-blind, parallel-group, GUIDE study
© 2023 Janssen Cilag GmbH and The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology..
BACKGROUND: Guselkumab is an interleukin (IL)-23 inhibitor with demonstrated efficacy in patients with psoriasis.
OBJECTIVES: Evaluate the impact of early disease intervention on clinical responses following 28 weeks of guselkumab treatment in patients with moderate-to-severe plaque psoriasis. Correlate clinical response and disease duration data with serum biomarker data.
METHODS: GUIDE is a phase IIIb randomized, double-blind, parallel-group, multicentre study of adults with moderate-to-severe plaque psoriasis. In study part 1, patients with a short disease duration (SDD [≤2 years]) or a long disease duration (LDD [>2 years]) received guselkumab 100 mg at Week (W) 0, 4, 12, and 20. Those achieving complete skin clearance at W20 and W28 were defined as a super responder (SRe). A multivariable logistic regression analysed the association between baseline factors and the likelihood of becoming an SRe. The relationship between clinical response, disease duration and serum biomarker data was assessed at W0 and 4.
RESULTS: In total, 880 patients were enrolled (SDD/LDD = 40.6%/59.4% of patients). More SDD than LDD patients achieved absolute Psoriasis Area and Severity Index (PASI) = 0 at W28 (51.8% vs. 39.4%) and were SRes (43.7% vs. 28.1% [overall 34.4%]). SDD patients also achieved PASI = 0 quicker than LDD patients (median 141 vs. 200 days). Disease duration and prior biologic use had the greatest impact on becoming an SRe, with no strong association among these independent variables. At baseline, there were no significant differences in the serum biomarker levels of IL-17A, IL-17F, IL-22 and β-defensin 2 between SDD and LDD patients, or between SRe and non-SRe patients. Guselkumab rapidly decreased these markers of systemic inflammation across all patient groups analysed at W4. Guselkumab was well tolerated.
CONCLUSIONS: Guselkumab efficacy was consistent across subpopulations, on the skin and systemically. The proportion of SRes was higher in SDD than LDD patients, indicating early treatment intervention may improve clinical outcomes.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:37 |
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| Enthalten in: |
Journal of the European Academy of Dermatology and Venereology : JEADV - 37(2023), 10 vom: 07. Okt., Seite 2016-2027 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Schäkel, K [VerfasserIn] |
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| Links: |
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| Themen: |
089658A12D |
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| Anmerkungen: |
Date Completed 26.09.2023 Date Revised 26.09.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/jdv.19236 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM357643887 |
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| 100 | 1 | |a Schäkel, K |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Early disease intervention with guselkumab in psoriasis leads to a higher rate of stable complete skin clearance ('clinical super response') |b Week 28 results from the ongoing phase IIIb randomized, double-blind, parallel-group, GUIDE study |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 26.09.2023 | ||
| 500 | |a Date Revised 26.09.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 Janssen Cilag GmbH and The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology. | ||
| 520 | |a BACKGROUND: Guselkumab is an interleukin (IL)-23 inhibitor with demonstrated efficacy in patients with psoriasis | ||
| 520 | |a OBJECTIVES: Evaluate the impact of early disease intervention on clinical responses following 28 weeks of guselkumab treatment in patients with moderate-to-severe plaque psoriasis. Correlate clinical response and disease duration data with serum biomarker data | ||
| 520 | |a METHODS: GUIDE is a phase IIIb randomized, double-blind, parallel-group, multicentre study of adults with moderate-to-severe plaque psoriasis. In study part 1, patients with a short disease duration (SDD [≤2 years]) or a long disease duration (LDD [>2 years]) received guselkumab 100 mg at Week (W) 0, 4, 12, and 20. Those achieving complete skin clearance at W20 and W28 were defined as a super responder (SRe). A multivariable logistic regression analysed the association between baseline factors and the likelihood of becoming an SRe. The relationship between clinical response, disease duration and serum biomarker data was assessed at W0 and 4 | ||
| 520 | |a RESULTS: In total, 880 patients were enrolled (SDD/LDD = 40.6%/59.4% of patients). More SDD than LDD patients achieved absolute Psoriasis Area and Severity Index (PASI) = 0 at W28 (51.8% vs. 39.4%) and were SRes (43.7% vs. 28.1% [overall 34.4%]). SDD patients also achieved PASI = 0 quicker than LDD patients (median 141 vs. 200 days). Disease duration and prior biologic use had the greatest impact on becoming an SRe, with no strong association among these independent variables. At baseline, there were no significant differences in the serum biomarker levels of IL-17A, IL-17F, IL-22 and β-defensin 2 between SDD and LDD patients, or between SRe and non-SRe patients. Guselkumab rapidly decreased these markers of systemic inflammation across all patient groups analysed at W4. Guselkumab was well tolerated | ||
| 520 | |a CONCLUSIONS: Guselkumab efficacy was consistent across subpopulations, on the skin and systemically. The proportion of SRes was higher in SDD than LDD patients, indicating early treatment intervention may improve clinical outcomes | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a guselkumab |2 NLM | |
| 650 | 7 | |a 089658A12D |2 NLM | |
| 650 | 7 | |a Antibodies, Monoclonal |2 NLM | |
| 650 | 7 | |a Biomarkers |2 NLM | |
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| 700 | 1 | |a Asadullah, K |e verfasserin |4 aut | |
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| 700 | 1 | |a Jullien, D |e verfasserin |4 aut | |
| 700 | 1 | |a Weisenseel, P |e verfasserin |4 aut | |
| 700 | 1 | |a Paul, C |e verfasserin |4 aut | |
| 700 | 1 | |a Gomez, M |e verfasserin |4 aut | |
| 700 | 1 | |a Wegner, S |e verfasserin |4 aut | |
| 700 | 1 | |a Personke, Y |e verfasserin |4 aut | |
| 700 | 1 | |a Kreimendahl, F |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Y |e verfasserin |4 aut | |
| 700 | 1 | |a Angsana, J |e verfasserin |4 aut | |
| 700 | 1 | |a Leung, M W L |e verfasserin |4 aut | |
| 700 | 1 | |a Eyerich, K |e verfasserin |4 aut | |
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