Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1
Objectives To evaluate the efficacy of guselkumab through four years of continuous treatment for psoriasis. Methods In the phase 3 VOYAGE 1 trial, 837 patients with moderate-to-severe psoriasis were randomized to receive guselkumab 100 mg every-8-weeks, placebo, or adalimumab 40 mg every-2-weeks. Pa...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2022-02-01
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| Series: | Journal of Dermatological Treatment |
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| Online Access: | http://dx.doi.org/10.1080/09546634.2020.1782817 |
| _version_ | 1797683545783664640 |
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| author | Christopher E. M. Griffiths Kim A. Papp Michael Song Megan Miller Yin You Yaung-Kaung Shen Chenglong Han Andrew Blauvelt |
| author_facet | Christopher E. M. Griffiths Kim A. Papp Michael Song Megan Miller Yin You Yaung-Kaung Shen Chenglong Han Andrew Blauvelt |
| author_sort | Christopher E. M. Griffiths |
| collection | DOAJ |
| description | Objectives To evaluate the efficacy of guselkumab through four years of continuous treatment for psoriasis. Methods In the phase 3 VOYAGE 1 trial, 837 patients with moderate-to-severe psoriasis were randomized to receive guselkumab 100 mg every-8-weeks, placebo, or adalimumab 40 mg every-2-weeks. Patients in the placebo and adalimumab groups crossed over to receive guselkumab at weeks 16/52, respectively; eligible patients received open-label guselkumab through week 204. Efficacy endpoints (i.e., PASI 75/90/100, IGA 0/1, and IGA 0) were analyzed in the guselkumab group using different methodologies: prespecified treatment failure rules (TFR, patients discontinued due to lack of efficacy, psoriasis worsening, or protocol-prohibited psoriasis treatment considered nonresponders); nonresponder imputation (NRI, patients with missing data counted as nonresponders); and As Observed (OBS, no imputation). Safety was evaluated through week 204. Results At week 204, PASI 90 response rates were 82.2%, 68.4%, and 84.3%, respectively, based on TFR, NRI, and OBS analyses; corresponding proportions at week 52 were 79.7%, 75.5%, and 80.6%. Similarly, PASI 75, PASI 100, IGA 0/1, and IGA 0 responses were maintained from week 52 through week 204. No new safety signals were identified. Conclusions High efficacy response rates were maintained through four years of continuous guselkumab treatment for psoriasis. |
| first_indexed | 2024-03-12T00:16:38Z |
| format | Article |
| id | doaj.art-19fab71775144eea838c878a81352672 |
| institution | Directory Open Access Journal |
| issn | 0954-6634 1471-1753 |
| language | English |
| last_indexed | 2024-03-12T00:16:38Z |
| publishDate | 2022-02-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Dermatological Treatment |
| spelling | doaj.art-19fab71775144eea838c878a813526722023-09-15T14:23:07ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532022-02-0133284885610.1080/09546634.2020.17828171782817Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1Christopher E. M. Griffiths0Kim A. Papp1Michael Song2Megan Miller3Yin You4Yaung-Kaung Shen5Chenglong Han6Andrew Blauvelt7Dermatology Centre, Salford Royal Hospital, University of Manchester, NIHR Manchester Biomedical Research CentreK Papp Clinical Research and Probity Research, IncJanssen Research & Development, LLCJanssen Research & Development, LLCJanssen Research & Development, LLCJanssen Research & Development, LLCJanssen Research & Development, LLCOregon Medical Research CenterObjectives To evaluate the efficacy of guselkumab through four years of continuous treatment for psoriasis. Methods In the phase 3 VOYAGE 1 trial, 837 patients with moderate-to-severe psoriasis were randomized to receive guselkumab 100 mg every-8-weeks, placebo, or adalimumab 40 mg every-2-weeks. Patients in the placebo and adalimumab groups crossed over to receive guselkumab at weeks 16/52, respectively; eligible patients received open-label guselkumab through week 204. Efficacy endpoints (i.e., PASI 75/90/100, IGA 0/1, and IGA 0) were analyzed in the guselkumab group using different methodologies: prespecified treatment failure rules (TFR, patients discontinued due to lack of efficacy, psoriasis worsening, or protocol-prohibited psoriasis treatment considered nonresponders); nonresponder imputation (NRI, patients with missing data counted as nonresponders); and As Observed (OBS, no imputation). Safety was evaluated through week 204. Results At week 204, PASI 90 response rates were 82.2%, 68.4%, and 84.3%, respectively, based on TFR, NRI, and OBS analyses; corresponding proportions at week 52 were 79.7%, 75.5%, and 80.6%. Similarly, PASI 75, PASI 100, IGA 0/1, and IGA 0 responses were maintained from week 52 through week 204. No new safety signals were identified. Conclusions High efficacy response rates were maintained through four years of continuous guselkumab treatment for psoriasis.http://dx.doi.org/10.1080/09546634.2020.1782817biologicsguselkumablong-termmaintenance of responsepsoriasis |
| spellingShingle | Christopher E. M. Griffiths Kim A. Papp Michael Song Megan Miller Yin You Yaung-Kaung Shen Chenglong Han Andrew Blauvelt Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1 Journal of Dermatological Treatment biologics guselkumab long-term maintenance of response psoriasis |
| title | Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1 |
| title_full | Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1 |
| title_fullStr | Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1 |
| title_full_unstemmed | Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1 |
| title_short | Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1 |
| title_sort | continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate to severe psoriasis results from voyage 1 |
| topic | biologics guselkumab long-term maintenance of response psoriasis |
| url | http://dx.doi.org/10.1080/09546634.2020.1782817 |
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