Bimekizumab Self-Injection Devices: Two Multicenter, Randomized, Open-Label Studies on Self-Administration by Patients With Psoriasis

February 2022 | Volume 21 | Issue 2 | Original Article | 162 | Copyright © February 2022


Published online January 31, 2022

Jerry Bagel MD,a Daljit Tatla,b Scarlett Hellot,c Bertram Knapp,d Charita Murphy,b Luke Peterson,b Michael Sebastian MDe

aPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ
bUCB Pharma, Raleigh, NC
cUCB Pharma, Colombes, France
dUCB Pharma, Monheim, Germany
eDermatological Practice Dr. med. Michael Sebastian, Mahlow, Germany

Abstract
Background: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A.
Objectives: To assess patients' ability to self-inject bimekizumab subcutaneously using a 1 mL safety syringe or auto-injector.
Methods: DV0002 and DV0006 were sub-studies of BE BRIGHT, a multicenter, phase 3 open-label extension study. Patients with moderate to severe plaque psoriasis received bimekizumab 320 mg (2x160 mg injections) every 4 or 8 weeks and were randomized 1:1 to the safety syringe or the auto-injector. The ability of patients to safely and effectively self-inject bimekizumab was assessed at 8 weeks (primary endpoint) and immediately after self-injection training at Baseline (secondary endpoint). Patient experience was evaluated using the pain visual analog scale (VAS; 0–100 mm; 100 being worst pain), and the Self-Injection Assessment Questionnaire (SIAQ; 0–10; 10 being most positive experience).
Results: All evaluable patients in DV0002 (n=125) and DV0006 (n=86) safely and effectively self-injected bimekizumab at Week 8. All evaluable patients in DV0002 who used the safety syringe (n=64) and 97.1% (n=66/68) who used the auto-injector, as well as all evaluable DV0006 patients (n=88) also self-injected bimekizumab safely and effectively at Baseline. Median VAS scores were low (range: 7.0–20.0), and median pre-injection and post-injection SIAQ scores were high (range: 5.8–10.0 and 7.1–10.0, respectively) across both devices, sub-studies, and timepoints.
Conclusions: Both devices provide a safe and effective option for patients to self-administer bimekizumab. Furthermore, patients reported a positive self-injection experience. Trial registration: NCT03766685

J Drugs Dermatol. 2022;21(2):162-171. doi:10.36849/JDD.6274

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INTRODUCTION

Plaque psoriasis is an immune-mediated inflammatory skin disease characterized by erythematous scaly plaques on patients' skin.1 The treatment of plaque psoriasis with biologics targeting key drivers of chronic inflammation in lesional skin, such as interleukin (IL)-17, is associated with the improvement of symptoms.2,3

The most common IL-17 inhibitors used to treat psoriasis target IL-17A alone.4,5 However, there is evidence that IL-17F also plays an important role in psoriasis pathogenesis and that inhibiting both IL-17A and IL-17F may be more effective.6,7 Bimekizumab is a monoclonal IgG1 antibody which selectively inhibits IL-17F in addition to IL-17A.8 In phase 2 and 3 clinical trials, bimekizumab treatment resulted in substantial clinical improvements in patients with moderate to severe plaque psoriasis.9-12

Biologics are often administered subcutaneously via self-injection. This offers patients many benefits, including more control over the injection setting and schedule, leading to greater feelings of independence and self-confidence.13-15 When adhered to, self-injection reduces costs for the healthcare system as patients no longer need to attend the hospital or clinic for regular injections.15 Nevertheless, there are barriers to self-injection, including needle phobia and patients’ lack of confidence.16,17 The design of self-injection devices can help patients overcome these barriers. For example, hidden needles can reduce needle phobia and larger grips make devices easier to hold and manipulate. Alongside training, these features may also increase treatment adherence.18,19

Some patients may prefer having a visible needle and control over self-injection speed.20 However, others may prefer a more
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