Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL
<p><strong>Objectives</strong> To assess 52-week safety and efficacy of bimekizumab in patients with active psoriatic arthritis (PsA) and prior inadequate response/intolerance to tumour necrosis factor inhibitors.</p> <p><strong>Methods</strong> Patients co...
| Main Authors: | , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Journal article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024
|
| _version_ | 1797112926705811456 |
|---|---|
| author | Coates, LC Landewé, R McInnes, IB Mease, PJ Ritchlin, CT Tanaka, Y Asahina, A Behrens, F Gladman, DD Gosse, L Orbai, A-M Gottlieb, AB Warren, RB Ink, B Bajracharya, R Shende, V Coarse, J Merola, JF |
| author_facet | Coates, LC Landewé, R McInnes, IB Mease, PJ Ritchlin, CT Tanaka, Y Asahina, A Behrens, F Gladman, DD Gosse, L Orbai, A-M Gottlieb, AB Warren, RB Ink, B Bajracharya, R Shende, V Coarse, J Merola, JF |
| author_sort | Coates, LC |
| collection | OXFORD |
| description | <p><strong>Objectives</strong> To assess 52-week safety and efficacy of bimekizumab in patients with active psoriatic arthritis (PsA) and prior inadequate response/intolerance to tumour necrosis factor inhibitors.</p>
<p><strong>Methods</strong> Patients completing the 16-week phase III double-blind, placebo-controlled BE COMPLETE (NCT03896581) study entered the open-label extension, BE VITAL (NCT04009499). All patients in BE VITAL received 160 mg bimekizumab every 4 weeks. Safety and efficacy are reported to week 52.</p>
<p><strong>Results</strong> A total of 347/400 (86.8%) patients completed week 52. To week 52, the exposure-adjusted incidence rate/100 patient-years for ≥1 treatment-emergent adverse event (TEAE) was 126.0, and was 7.0 for serious TEAEs. The most frequent TEAEs were SARS-CoV-2 (COVID-19), oral candidiasis, nasopharyngitis and urinary tract infection. All fungal infections were mild or moderate in severity and localised; two patients discontinued the study due to oral candidiasis. No cases of active tuberculosis, uveitis or inflammatory bowel disease were reported. One sudden death occurred. Sustained efficacy was observed with bimekizumab from week 16 to 52 across clinical and patient-reported outcomes. At week 52, 51.7% bimekizumab-randomised and 40.6% placebo/bimekizumab patients (receiving bimekizumab from week 16 to 52) had ≥50% improvement in the American College of Rheumatology criteria. Complete skin clearance (Psoriasis Area and Severity Index 100) was achieved by 65.9% bimekizumab and 60.2% placebo/bimekizumab patients at week 52. Minimal disease activity was achieved by 47.2% bimekizumab and 33.1% placebo/bimekizumab patients at week 52.</p>
<p><strong>Conclusions</strong> Bimekizumab demonstrated a safety profile consistent with previous reports; no new safety signals were identified. Sustained efficacy was observed from week 16 to 52.</p> |
| first_indexed | 2024-03-07T08:18:50Z |
| format | Journal article |
| id | oxford-uuid:8704cdb9-6046-4c2a-b380-d171f59694d0 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-04-09T03:56:08Z |
| publishDate | 2024 |
| publisher | BMJ Publishing Group |
| record_format | dspace |
| spelling | oxford-uuid:8704cdb9-6046-4c2a-b380-d171f59694d02024-03-14T13:48:46ZBimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITALJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:8704cdb9-6046-4c2a-b380-d171f59694d0EnglishSymplectic ElementsBMJ Publishing Group2024Coates, LCLandewé, RMcInnes, IBMease, PJRitchlin, CTTanaka, YAsahina, ABehrens, FGladman, DDGosse, LOrbai, A-MGottlieb, ABWarren, RBInk, BBajracharya, RShende, VCoarse, JMerola, JF<p><strong>Objectives</strong> To assess 52-week safety and efficacy of bimekizumab in patients with active psoriatic arthritis (PsA) and prior inadequate response/intolerance to tumour necrosis factor inhibitors.</p> <p><strong>Methods</strong> Patients completing the 16-week phase III double-blind, placebo-controlled BE COMPLETE (NCT03896581) study entered the open-label extension, BE VITAL (NCT04009499). All patients in BE VITAL received 160 mg bimekizumab every 4 weeks. Safety and efficacy are reported to week 52.</p> <p><strong>Results</strong> A total of 347/400 (86.8%) patients completed week 52. To week 52, the exposure-adjusted incidence rate/100 patient-years for ≥1 treatment-emergent adverse event (TEAE) was 126.0, and was 7.0 for serious TEAEs. The most frequent TEAEs were SARS-CoV-2 (COVID-19), oral candidiasis, nasopharyngitis and urinary tract infection. All fungal infections were mild or moderate in severity and localised; two patients discontinued the study due to oral candidiasis. No cases of active tuberculosis, uveitis or inflammatory bowel disease were reported. One sudden death occurred. Sustained efficacy was observed with bimekizumab from week 16 to 52 across clinical and patient-reported outcomes. At week 52, 51.7% bimekizumab-randomised and 40.6% placebo/bimekizumab patients (receiving bimekizumab from week 16 to 52) had ≥50% improvement in the American College of Rheumatology criteria. Complete skin clearance (Psoriasis Area and Severity Index 100) was achieved by 65.9% bimekizumab and 60.2% placebo/bimekizumab patients at week 52. Minimal disease activity was achieved by 47.2% bimekizumab and 33.1% placebo/bimekizumab patients at week 52.</p> <p><strong>Conclusions</strong> Bimekizumab demonstrated a safety profile consistent with previous reports; no new safety signals were identified. Sustained efficacy was observed from week 16 to 52.</p> |
| spellingShingle | Coates, LC Landewé, R McInnes, IB Mease, PJ Ritchlin, CT Tanaka, Y Asahina, A Behrens, F Gladman, DD Gosse, L Orbai, A-M Gottlieb, AB Warren, RB Ink, B Bajracharya, R Shende, V Coarse, J Merola, JF Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL |
| title | Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL |
| title_full | Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL |
| title_fullStr | Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL |
| title_full_unstemmed | Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL |
| title_short | Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL |
| title_sort | bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors 52 week safety and efficacy from the phase iii be complete study and its open label extension be vital |
| work_keys_str_mv | AT coateslc bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT landewer bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT mcinnesib bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT measepj bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT ritchlinct bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT tanakay bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT asahinaa bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT behrensf bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT gladmandd bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT gossel bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT orbaiam bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT gottliebab bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT warrenrb bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT inkb bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT bajracharyar bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT shendev bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT coarsej bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital AT merolajf bimekizumabtreatmentinpatientswithactivepsoriaticarthritisandpriorinadequateresponsetotumournecrosisfactorinhibitors52weeksafetyandefficacyfromthephaseiiibecompletestudyanditsopenlabelextensionbevital |