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

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.

Safe and Effective Subcutaneous Self-Injection of Bimekizumab with Safety Syringe and Auto-Injector Devices: Results from a Multicenter, Randomized, Open-Label Study in Patients with Psoriatic Arthritis

“…The SSy is a modified syringe with a large smooth grip area for optimal needle control, extended finger flange, and plunger rod for enhanced device usability, depicted in Bagel et al, 2022. 2 To use the SSy, patients removed the over-cap, safely positioned the visible needle at the injection site (either the lateral abdominal wall or outer thigh), fully depressed the plunger rod which emptied the syringe contents (bimekizumab) through the needle into the subcutaneous space, and upon completion of the injection, automatically withdrew the needle into the body of the SSy. The AI was designed with a large smooth grip area, hidden needle to reduce needle phobia, and a window to ensure all syringe contents are emptied.…”

“… 3–9 The drug is administered subcutaneously, either by a healthcare professional or via self-injection. 2 …”

“… 10 , 11 Despite these benefits, some patients face barriers to self-injection such as needle anxiety and lack of confidence. 2 While some patients prefer greater control over the self-injection process, others prefer less control and a more automatic self-injection. 2 , 12 Given these considerations, it is important that patients who require bimekizumab treatment have safe and effective self-injection options that meet their needs and preferences.…”

“…Safe and effective subcutaneous self-injection and a positive patient self-injection experience with the 1 mL bimekizumab safety syringe (SSy) and the 1 mL bimekizumab auto-injector (AI) device has been demonstrated in patients with psoriasis in two sub-studies (DV0002 and DV0006) of the BE BRIGHT (NCT03766685) open-label extension study in the bimekizumab clinical program. 2 However, self-injection using these devices in patients with active PsA has not been evaluated. PsA is a chronic, heterogenous, inflammatory disease with broad clinical manifestations, including musculoskeletal (stiffness, pain, and swelling of the small joints of the hand) and dermatological (psoriatic skin lesions) symptoms of varying severity.…”

Customer-centric product presentations for monoclonal antibodies

“…A more significant step in reducing dosing regimen-related inconvenience, healthcare institutional spending and in improving affordability and access to mAb treatments is to shift dosing outside of the clinical setting (Wolfromm et al 2017 ; Bittner et al 2018 ; Bittner and Schmidt 2021 ). Here, subcutaneous at-home- and self-administration has become an established dosing regimen for mAbs with a favorable safety and tolerability profile across different disease areas (Gottlieb et al 2016 , Raffaelli et al 2019 , Van den Bemt et al 2019 , Timmermann et al 2020 , Jappe et al 2021 , Bagel et al 2022 ). Especially low-volume subcutaneous injections can be self-administered by means of a variety of prefilled syringes or pen device types, thus accounting for personal priorities and capabilities (Anderson and Redondo 2011 ; Vermeire et al 2018 ).…”