Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced
Objective Evaluation of the efficacy and safety of guselkumab, a human monoclonal antibody targeting the interleukin-23p19 subunit, in patients with psoriatic arthritis (PsA) through 1 year.Methods Adults who met ClASsification criteria for Psoriatic ARthritis, with active disease (≥3 swollen and ≥3...
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2021
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oai:doaj.org-article:ae559d22818b49b5b84a51d05b30ba532021-11-23T16:00:10ZGuselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced10.1136/rmdopen-2020-0014572056-5933https://doaj.org/article/ae559d22818b49b5b84a51d05b30ba532021-01-01T00:00:00Zhttps://rmdopen.bmj.com/content/7/1/e001457.fullhttps://doaj.org/toc/2056-5933Objective Evaluation of the efficacy and safety of guselkumab, a human monoclonal antibody targeting the interleukin-23p19 subunit, in patients with psoriatic arthritis (PsA) through 1 year.Methods Adults who met ClASsification criteria for Psoriatic ARthritis, with active disease (≥3 swollen and ≥3 tender joints; C reactive protein ≥0.3 mg/dL) despite standard treatment (31% previously received ≤2 tumour necrosis factor inhibitors (TNFi)), were randomised (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week0, Week4, then Q8W; or placebo with cross-over to guselkumab 100 mg Q4W at Week24 (PBO→Q4W) through Week48. Clinical efficacy through Week52 (employing non-responder imputation) and adverse events (AEs) through Week60 were evaluated.Results Of 381 treated patients, 90% completed the study. Numerical increases in the proportions of patients achieving ≥20% improvement in ACR criteria (ACR20) were observed post-Week24, reaching 73% (94/128) and 60% (76/127) for Q4W-randomised and Q8W-randomised patients, respectively, by Week52. Proportions of patients achieving ACR50/ACR70/skin responses and minimal/very low disease activity were maintained, as were improvements in physical function and health-related quality of life, through Week52 in guselkumab-randomised patients. Response to guselkumab was maintained in both TNFi-naïve and TNFi-experienced patients. Serious AEs and serious infections occurred in similar proportions of guselkumab Q4W-randomised (3% and 0%) and Q8W-randomised (6% and 2%) patients through Week60, with no new safety concerns versus observations through Week24. No guselkumab-treated patient and two patients receiving placebo died; no study participant developed opportunistic infection or inflammatory bowel disease.Conclusion Guselkumab provided sustained improvement across multiple clinical manifestations of PsA, maintaining a favourable benefit-risk profile, through 1 year regardless of prior TNFi exposure.Atul DeodharShihong ShengPhilip S HelliwellSoumya D ChakravartyElizabeth C HsiaEnrique R SorianoChetan S KaryekarWolf-Henning BoehnckePrasheen AgarwalAlexa P KollmeierFederico ZazzettiRamanand A SubramanianXie L XuQing C ZurawYusang JiangBei ZhouYanli ZhuangMay ShawiBMJ Publishing GrouparticleMedicineRENRMD Open, Vol 7, Iss 1 (2021) |
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Medicine R |
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Medicine R Atul Deodhar Shihong Sheng Philip S Helliwell Soumya D Chakravarty Elizabeth C Hsia Enrique R Soriano Chetan S Karyekar Wolf-Henning Boehncke Prasheen Agarwal Alexa P Kollmeier Federico Zazzetti Ramanand A Subramanian Xie L Xu Qing C Zuraw Yusang Jiang Bei Zhou Yanli Zhuang May Shawi Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced |
| description |
Objective Evaluation of the efficacy and safety of guselkumab, a human monoclonal antibody targeting the interleukin-23p19 subunit, in patients with psoriatic arthritis (PsA) through 1 year.Methods Adults who met ClASsification criteria for Psoriatic ARthritis, with active disease (≥3 swollen and ≥3 tender joints; C reactive protein ≥0.3 mg/dL) despite standard treatment (31% previously received ≤2 tumour necrosis factor inhibitors (TNFi)), were randomised (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week0, Week4, then Q8W; or placebo with cross-over to guselkumab 100 mg Q4W at Week24 (PBO→Q4W) through Week48. Clinical efficacy through Week52 (employing non-responder imputation) and adverse events (AEs) through Week60 were evaluated.Results Of 381 treated patients, 90% completed the study. Numerical increases in the proportions of patients achieving ≥20% improvement in ACR criteria (ACR20) were observed post-Week24, reaching 73% (94/128) and 60% (76/127) for Q4W-randomised and Q8W-randomised patients, respectively, by Week52. Proportions of patients achieving ACR50/ACR70/skin responses and minimal/very low disease activity were maintained, as were improvements in physical function and health-related quality of life, through Week52 in guselkumab-randomised patients. Response to guselkumab was maintained in both TNFi-naïve and TNFi-experienced patients. Serious AEs and serious infections occurred in similar proportions of guselkumab Q4W-randomised (3% and 0%) and Q8W-randomised (6% and 2%) patients through Week60, with no new safety concerns versus observations through Week24. No guselkumab-treated patient and two patients receiving placebo died; no study participant developed opportunistic infection or inflammatory bowel disease.Conclusion Guselkumab provided sustained improvement across multiple clinical manifestations of PsA, maintaining a favourable benefit-risk profile, through 1 year regardless of prior TNFi exposure. |
| format |
article |
| author |
Atul Deodhar Shihong Sheng Philip S Helliwell Soumya D Chakravarty Elizabeth C Hsia Enrique R Soriano Chetan S Karyekar Wolf-Henning Boehncke Prasheen Agarwal Alexa P Kollmeier Federico Zazzetti Ramanand A Subramanian Xie L Xu Qing C Zuraw Yusang Jiang Bei Zhou Yanli Zhuang May Shawi |
| author_facet |
Atul Deodhar Shihong Sheng Philip S Helliwell Soumya D Chakravarty Elizabeth C Hsia Enrique R Soriano Chetan S Karyekar Wolf-Henning Boehncke Prasheen Agarwal Alexa P Kollmeier Federico Zazzetti Ramanand A Subramanian Xie L Xu Qing C Zuraw Yusang Jiang Bei Zhou Yanli Zhuang May Shawi |
| author_sort |
Atul Deodhar |
| title |
Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced |
| title_short |
Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced |
| title_full |
Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced |
| title_fullStr |
Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced |
| title_full_unstemmed |
Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced |
| title_sort |
guselkumab, an inhibitor of the il-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase iii randomised study of patients who were biologic-naïve or tnfα inhibitor-experienced |
| publisher |
BMJ Publishing Group |
| publishDate |
2021 |
| url |
https://doaj.org/article/ae559d22818b49b5b84a51d05b30ba53 |
| work_keys_str_mv |
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