Bimekizumab in Patients with Moderate to Severe Plaque Psoriasis: Analysis of Mental Health and Associated Disorders

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Andrew Blauvelt
April Armstrong
Joseph F. Merola
Bruce Strober
Dirk de Cuyper
Luke Peterson
Owen Davies
Jeffrey L. Stark
Mark Lebwohl


bimekizumab, psoriasis, safety, mental health, suicide, suicidality, plaque psoriasis, depression, clinical trial


Introduction: Patients (pts) with psoriasis have a greater risk of depression and suicidality than the general population.1 Here, we report Week (Wk)16 and longer-term depression and suicidal ideation and behavior (SIB) data in bimekizumab (BKZ)-treated pts with moderate to severe plaque psoriasis.

Procedure/study: The Patient Health Questionnaire (PHQ)-9, scored 0–27, measured depression severity monthly to Wk16 (regular intervals during BE BRIGHT open-label extension);2,3 higher scores indicate worse depression. PHQ-9 data were pooled from Wk0–16 of BE VIVID/BE READY (BKZ 320mg every 4 weeks [Q4W] vs. placebo [PBO]);4,5 3-year BE BRIGHT data are also reported.3 An independent Neuropsychiatric Adjudication Committee evaluated potential SIB treatment-emergent adverse events (TEAEs) and elevated PHQ-9 scores. Adjudicated SIB (suicide completion/attempt/ideation) incidence/100 pt-years (yrs; PY) was pooled from nine BKZ phase 2/3/3b trials in psoriasis, including up to 5 yrs’ exposure.3–11

Results: At Wk16, mean reduction from baseline in PHQ-9 with BKZ Q4W (N=670) vs. PBO (N=169) was 1.3 vs. 0.3; overall mean Wk16 scores were 1.2 and 2.4 for BKZ and PBO. Low mean BKZ PHQ-9 scores were maintained over 3 yrs of BE BRIGHT following the feeder studies (Wk144: 1.2). At Wk16, 92.9% of BKZ pts scored 0–4 in PHQ-9 (no/minimal depression) vs. 81.1% of PBO pts; 1.3% vs. 6.3% scored ≥10 (moderate–severe depression). Through Wk16, 0.7% BKZ vs. 4.1% PBO pts scored ≥15 (moderately severe–severe) in PHQ-9 at any visit. Over 7,166 PY of BKZ exposure (N=2,480), the rate of adjudicated SIB TEAEs was 0.126/100 PY.

Conclusion: PHQ-9 scores were low through Wk16 and remained low with longer BKZ exposure. The vast majority of BKZ pts had no/minimal depression at Wk16. The long-term incidence rate of adjudicated SIB with BKZ was low and similar to the general psoriasis population (range: 0.09–0.54/100 PY).1,12

Funding: UCB Pharma.


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11. PS0018:;

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