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Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo‐Controlled DISCOVER‐1 Study
OBJECTIVE: To evaluate efficacy and safety of the interleukin‐23p19‐subunit inhibitor, guselkumab, in DISCOVER‐1 patients with active psoriatic arthritis (PsA) by prior use of tumor necrosis factor inhibitor (TNFi). METHODS: The phase 3, randomized, placebo‐controlled DISCOVER‐1 study enrolled patie...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wiley Periodicals, Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10010489/ https://www.ncbi.nlm.nih.gov/pubmed/36762512 http://dx.doi.org/10.1002/acr2.11523 |
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author | Ritchlin, Christopher T. Deodhar, Atul Boehncke, Wolf‐Henning Soriano, Enrique R. Kollmeier, Alexa P. Xu, Xie L. Zazzetti, Federico Shawi, May Jiang, Yusang Sheng, Shihong Helliwell, Philip S. |
author_facet | Ritchlin, Christopher T. Deodhar, Atul Boehncke, Wolf‐Henning Soriano, Enrique R. Kollmeier, Alexa P. Xu, Xie L. Zazzetti, Federico Shawi, May Jiang, Yusang Sheng, Shihong Helliwell, Philip S. |
author_sort | Ritchlin, Christopher T. |
collection | PubMed |
description | OBJECTIVE: To evaluate efficacy and safety of the interleukin‐23p19‐subunit inhibitor, guselkumab, in DISCOVER‐1 patients with active psoriatic arthritis (PsA) by prior use of tumor necrosis factor inhibitor (TNFi). METHODS: The phase 3, randomized, placebo‐controlled DISCOVER‐1 study enrolled patients with active PsA (swollen joint count ≥3, tender joint count ≥3, and C‐reactive protein level ≥ 0.3 mg/dl) despite standard therapies; approximately one‐third could have received two or fewer prior TNFi. Patients were randomized to 100 mg of guselkumab every 4 weeks (Q4W); 100 mg of guselkumab at week 0, at week 4, and every 8 weeks (Q8W); or placebo with crossover to guselkumab Q4W at week 24. Efficacy end points of ≥20% and ≥50% improvement in individual American College of Rheumatology (ACR) criteria and achieving the minimal disease activity (MDA) components were summarized by prior TNFi status. RESULTS: In DISCOVER‐1, 118 (31%) patients previously received one or two TNFi. As previously reported, rates for acheiving ≥20% improvement in the composite ACR response at week 24 and week 52 were similar in TNFi‐naive and TNFi‐experienced patients randomized to guselkumab Q4W (76% and 68%, respectively) and Q8W (61% and 58%, respectively). Similar trends were observed for response rates of ≥20% and ≥50% improvement in individual ACR criteria and for achieving individual MDA components at week 24; TNFi‐naive patients were more likely to achieve end points related to physical function and pain than TNFi‐experienced patients. Overall, response rates were maintained or increased through week 52 regardless of prior TNFi use. Through week 60 in guselkumab‐treated TNFi‐naive and TNFi‐experienced patients, 62% and 64%, respectively, reported one or more adverse events (AEs); 4% and 6% had serious AEs, respectively. CONCLUSION: Through 1 year, 100 mg of guselkumab Q4W and Q8W provided sustained improvements across multiple domains in both TNFi‐naive and TNFi‐experienced patients with active PsA. |
format | Online Article Text |
id | pubmed-10010489 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Wiley Periodicals, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-100104892023-03-14 Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo‐Controlled DISCOVER‐1 Study Ritchlin, Christopher T. Deodhar, Atul Boehncke, Wolf‐Henning Soriano, Enrique R. Kollmeier, Alexa P. Xu, Xie L. Zazzetti, Federico Shawi, May Jiang, Yusang Sheng, Shihong Helliwell, Philip S. ACR Open Rheumatol Original Articles OBJECTIVE: To evaluate efficacy and safety of the interleukin‐23p19‐subunit inhibitor, guselkumab, in DISCOVER‐1 patients with active psoriatic arthritis (PsA) by prior use of tumor necrosis factor inhibitor (TNFi). METHODS: The phase 3, randomized, placebo‐controlled DISCOVER‐1 study enrolled patients with active PsA (swollen joint count ≥3, tender joint count ≥3, and C‐reactive protein level ≥ 0.3 mg/dl) despite standard therapies; approximately one‐third could have received two or fewer prior TNFi. Patients were randomized to 100 mg of guselkumab every 4 weeks (Q4W); 100 mg of guselkumab at week 0, at week 4, and every 8 weeks (Q8W); or placebo with crossover to guselkumab Q4W at week 24. Efficacy end points of ≥20% and ≥50% improvement in individual American College of Rheumatology (ACR) criteria and achieving the minimal disease activity (MDA) components were summarized by prior TNFi status. RESULTS: In DISCOVER‐1, 118 (31%) patients previously received one or two TNFi. As previously reported, rates for acheiving ≥20% improvement in the composite ACR response at week 24 and week 52 were similar in TNFi‐naive and TNFi‐experienced patients randomized to guselkumab Q4W (76% and 68%, respectively) and Q8W (61% and 58%, respectively). Similar trends were observed for response rates of ≥20% and ≥50% improvement in individual ACR criteria and for achieving individual MDA components at week 24; TNFi‐naive patients were more likely to achieve end points related to physical function and pain than TNFi‐experienced patients. Overall, response rates were maintained or increased through week 52 regardless of prior TNFi use. Through week 60 in guselkumab‐treated TNFi‐naive and TNFi‐experienced patients, 62% and 64%, respectively, reported one or more adverse events (AEs); 4% and 6% had serious AEs, respectively. CONCLUSION: Through 1 year, 100 mg of guselkumab Q4W and Q8W provided sustained improvements across multiple domains in both TNFi‐naive and TNFi‐experienced patients with active PsA. Wiley Periodicals, Inc. 2023-02-10 /pmc/articles/PMC10010489/ /pubmed/36762512 http://dx.doi.org/10.1002/acr2.11523 Text en © 2023 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Ritchlin, Christopher T. Deodhar, Atul Boehncke, Wolf‐Henning Soriano, Enrique R. Kollmeier, Alexa P. Xu, Xie L. Zazzetti, Federico Shawi, May Jiang, Yusang Sheng, Shihong Helliwell, Philip S. Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo‐Controlled DISCOVER‐1 Study |
title | Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo‐Controlled DISCOVER‐1 Study |
title_full | Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo‐Controlled DISCOVER‐1 Study |
title_fullStr | Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo‐Controlled DISCOVER‐1 Study |
title_full_unstemmed | Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo‐Controlled DISCOVER‐1 Study |
title_short | Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo‐Controlled DISCOVER‐1 Study |
title_sort | multidomain efficacy and safety of guselkumab through 1 year in patients with active psoriatic arthritis with and without prior tumor necrosis factor inhibitor experience: analysis of the phase 3, randomized, placebo‐controlled discover‐1 study |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10010489/ https://www.ncbi.nlm.nih.gov/pubmed/36762512 http://dx.doi.org/10.1002/acr2.11523 |
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