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. 2025 Mar 29;15(5):1113–1134. doi: 10.1007/s13555-025-01366-6

Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector

Michael Sebastian 1,✉, Jerry Bagel 2,3, Bengt Hoepken 4, Bertram Knapp 4, Ceyhun Bicer 5, Merran MacPherson 5, Richard G Langley 6
PMCID: PMC12033148  PMID: 40156698

Abstract

Introduction

Bimekizumab has a favourable safety profile and has demonstrated rapid and superior efficacy, compared with placebo, adalimumab, ustekinumab, and secukinumab, in treating psoriasis. A previous study demonstrated the safe and effective subcutaneous self-injection of 320 mg bimekizumab via two 1 mL (2 × 160 mg) doses using safety syringe (SSy) or auto-injector (AI) devices. Delivery of 320 mg bimekizumab via a single 2 mL self-injection could lead to an improved treatment experience for patients.

Methods

We describe the results from four studies. Two self-injection experience studies (DV0002 [n = 38] and DV0006 [n = 89], sub-studies of the phase 3 study BE BRIGHT [NCT03598790]) assessed the safe and effective self-administration of bimekizumab at week 8 and baseline, as well as patient self-injection experience and pain, in patients with moderate to severe plaque psoriasis using the 2 mL SSy or AI. Additionally, we report on two bioequivalence studies (UP0068 [n = 71] and UP0119 [n = 121]) that describe pharmacokinetic profiles for two 1 mL injections and a single 2 mL injection, delivered by SSy or AI devices in healthy participants.

Results

All patients were able to administer safe and effective self-injections at baseline and week 8 using the different 2 mL devices, except one patient that administered an incomplete dose as a result of injection site pain that was mild. Overall, bimekizumab was generally well tolerated and all adverse device effects reported were mild and did not lead to discontinuation. Patients reported a positive self-injection experience with low pain scores (all ≤ 12.0/100). Bioequivalence was demonstrated for bimekizumab between a single 2 mL injection and two 1 mL injections, using both the SSy and AI.

Conclusion

The 2 mL SSy and AI devices offer patients with moderate to severe plaque psoriasis two different safe and effective options for the delivery of bimekizumab, empowering individuals to select a device on the basis of personal preference.

Graphical abstract available for this article.

Trial Registration

ClinicalTrials.gov identifier, NCT03766685.

Graphical Abstract

graphic file with name 13555_2025_1366_Figa_HTML.jpg

Supplementary Information

The online version contains supplementary material available at 10.1007/s13555-025-01366-6.

Keywords: Auto-injector, Bimekizumab, Bioequivalence, Plaque psoriasis, Safety syringe, Self-injection

Plain Language Summary

Plaque psoriasis is a skin disease that causes red, scaly skin patches that can flake, itch and hurt. It affects around 90% of people with psoriasis, and symptoms can negatively impact quality of life. Therefore, individuals want effective and easy to deliver treatment options. Bimekizumab is a medication used to treat psoriasis. Currently, each dose (320 mg) of bimekizumab is delivered via two 1 mL self-injections. These studies investigated whether a single 2 mL self-injection with one of two devices (safety syringe or auto-injector) could deliver the medication safely and effectively and whether a single 2 mL injection works in the same way as delivering bimekizumab with two injections. These studies were conducted because it is important to give patients options for their treatment delivery to suit their personal preferences and to reduce the number of injections required, minimising the burden of treatment. Everyone except one person was able to safely and effectively self-inject using both 2 mL devices. On average, people involved in the study reported a positive experience and low levels of pain (all ≤ 12.0/100) with both devices. Bimekizumab was well tolerated, and any reactions assessed to be related to the injection devices were mild and did not stop anyone receiving the treatment. A 320 mg dose of bimekizumab behaved similarly in the body when delivered by two 1 mL injections or a single 2 mL injection using either the safety syringe or auto-injector.

Supplementary Information

The online version contains supplementary material available at 10.1007/s13555-025-01366-6.

Key Summary Points

Why carry out this study?
Delivery of bimekizumab via a single 2 mL self-injection (320 mg), instead of two 1 mL self-injections (2 × 160 mg), could lead to an improved treatment experience for patients with plaque psoriasis that receive 320 mg of bimekizumab.
This study presents the results from two self-injection experience studies (DV0002 and DV0006) and two bioequivalence studies (UP0068 and UP0119).
What was learned from the study?
All patients, except for one at week 8, were able to administer safe and effective self-injections at baseline and week 8 using the single 2 mL self-injection for both the safety syringe (SSy) and auto-injector (AI) devices.
Bioequivalence was demonstrated for bimekizumab between the single 2 mL and two 1 mL dosage volumes, using both the SSy and AI devices studied.
Patients with plaque psoriasis can choose between two safe and effective 2 mL devices, allowing them to select on the basis of personal preference and administer the dose via a single self-injection.
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Digital Features

This article is published with digital features, including a graphical abstract, to facilitate understanding of the article. To view digital features for this article, go to 10.6084/m9.figshare.28410170.

Introduction

Plaque psoriasis is a chronic, immune-mediated inflammatory skin disease, characterised by red skin patches covered with silver scales [1, 2]. Biologic therapies aim to treat plaque psoriasis by targeting and selectively inhibiting proinflammatory cytokines, which are key drivers of chronic, psoriatic inflammation [3, 4]. Bimekizumab is a humanised monoclonal immunoglobulin (Ig)G1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A [5–7]. Bimekizumab has demonstrated rapid and superior efficacy compared with placebo, adalimumab, ustekinumab, and secukinumab, in phase 3/3b trials of patients with moderate to severe plaque psoriasis, as well as a comparable safety profile to previous studies, with high efficacy levels maintained through 4 years in clinical trials [8–15]. The safety and efficacy of bimekizumab treatment has also been evaluated in phase 3 trials of patients with active psoriatic arthritis (PsA), hidradenitis suppurativa (HS), and axial spondyloarthritis (axSpA), with clinically meaningful improvements reported for all patient populations [16–21]. Bimekizumab is administered via subcutaneous injection, either by a healthcare professional or via self-injection [7]. Whilst patients with PsA and axSpA are indicated to receive a single 160 mg dose of bimekizumab as the full dose via a 1 mL device, patients with psoriasis and HS are indicated to receive 320 mg bimekizumab via two 1 mL self-injections [22, 23].

Self-injection offers numerous benefits for patients, especially those with chronic disease requiring long-term therapy, including independence and autonomy over the injection timing and setting, and has been shown to improve overall treatment experience and health-related quality of life for patients [24, 25]. However, barriers remain to self-injection, such as fear of needles, lack of confidence, anxiety, and ease of use [26]. Efforts have been made to design patient-centric self-injection devices; however, self-injection preference can vary amongst patients, making it important to provide a variety of options [24, 27].

Two 1 mL self-injection devices, a safety syringe (SSy) and an auto-injector (AI), have been developed to provide users with the option of greater control over the self-injection process with a manual syringe or an automatic and quick self-injection, respectively [7]. A previous study investigated self-injection experience in patients with plaque psoriasis when self-injecting 1 mL of bimekizumab 160 mg using the SSy or the AI twice to administer the full 320 mg dose [7]. Both devices were deemed as safe and effective options for self-injection, with an overall positive experience amongst patients [7].

Delivery of 320 mg bimekizumab via a single 2 mL self-injection device could lead to an improved treatment experience for patients with psoriasis, as well as patients with HS, who are also indicated to receive a 320 mg dose. A single self-injection could offer several advantages, including improved patient adherence, as well as reducing costs for healthcare systems [28]. However, using a single 2 mL injection at one injection site instead of two 1 mL injections, typically at different injection sites, could impact the relative bioavailability of bimekizumab, which plays a crucial role in the pharmacokinetics (PK), and consequently the efficacy and safety of bimekizumab treatment [29–31]. Bioequivalence can be demonstrated between two pharmaceutical products, containing the same active substance, if the release of a drug substance from a drug product, and subsequent absorption into the systemic circulation (i.e. the PK profile), is equivalent to the other drug product [30, 32].

Here, we report the results from two self-injection experience studies (DV0002 and DV0006), which aimed to evaluate the ability of patients with moderate to severe plaque psoriasis to safely and effectively self-inject bimekizumab using the 2 mL SSy or AI devices. We also report the results from two bioequivalence studies (UP0068 and UP0119), which aimed to demonstrate the equivalence of bimekizumab delivered using two different injection dosage volumes, two 1 mL and a single 2 mL, with the SSy or AI devices.

Methods

Study Objectives

Self-Injection Experience Studies (DV0002/DV0006)

The primary and secondary objectives of DV0002 and DV0006 were to assess the ability of patients with moderate to severe plaque psoriasis to safely and effectively self-administer 2 mL bimekizumab at week 8 and baseline, respectively, using both the SSy and AI. Other objectives included patient experience of self-injection, assessed by the Self-Injection Assessment Questionnaire (SIAQ) and the pain visual analogue scale (VAS). Additionally, post-use structural and functional integrity of the devices was explored.

Bioequivalence Studies (UP0068/UP0119)

The primary objective of the UP0068 and UP0119 studies was to assess bioequivalence between the single 2 mL (320 mg) versus two 1 mL (2 × 160 mg) volumes, using both the SSy and AI devices (UP0068) and the AI device (UP0119) alone. UP0068 and UP0119 included healthy subjects, referred to as participants. The secondary objective of these studies was to assess the safety and tolerability of the single 2 mL versus two 1 mL dosage volumes.

Self-Injecting Devices

The 2 mL SSy and 2 mL AI devices were assessed in these studies (Fig. S1, Supplementary Material). Features of both devices have been described previously in a study that used 1 mL pre-filled syringes [7]. The 2 mL pre-filled syringe of bimekizumab was developed containing the same formulation as the previous 1 mL pre-filled syringe, with the 2 mL (320 mg) pre-filled syringe assembled into either an SSy or AI.

Study Design and Participants

Self-Injection Experience Studies (DV0002/DV0006)

DV0002 (USA and Canada)/DV0006 (Germany, Hungary, and Poland), two sub-studies of the phase 3 study BE BRIGHT (NCT03598790), were multicentre, randomised, open-label extension studies that evaluated the use of two 1 mL or a single 2 mL prefilled SSy and AI for the subcutaneous self-injection of bimekizumab in patients with moderate to severe plaque psoriasis [7, 13, 33, 34]. The full study design has been reported previously, and here, we report the results from patients receiving a single 2 mL injection [7].

Briefly, for both DV0002 and DV0006, maximum study duration was 16 weeks for each patient (Fig. S2, Supplementary Material). Included patients received bimekizumab 320 mg every 4 weeks (Q4W) or every 8 weeks (Q8W) on the basis of their treatment regimen and Psoriasis Area Severity Index (PASI) response at BE BRIGHT entry. For full details of the patient inclusion and exclusion criteria, see Table S1 (Supplementary Material). Both studies were conducted in accordance with the principles of the Declaration of Helsinki and were approved by an independent review board and independent ethics committee. All participants provided informed written consent.

Eligible patients were randomly assigned in a 1:1 ratio to either the SSy (BKZ-SSy-1 × 2 mL) or AI (BKZ-AI-1 × 2 mL) group to perform a single 2 mL self-injection of bimekizumab 320 mg. At baseline, each patient was provided with training in self-injection and received the instructions for use and any other applicable training materials.

Self-injection was performed at baseline, which was immediately after training, and at week 8 without additional training. Further details on injection delivery and the injection site have been previously published [7].

Bioequivalence Studies (UP0068/UP0119)

Two bioequivalence studies, UP0068 and UP0119, were conducted to demonstrate bioequivalence of the 2 mL devices to their respective 1 mL reference products. These studies were designed following the completion of a relative bioavailability study, UP0074, that demonstrated similar relative bioavailability of bimekizumab when given as two 1 mL device-free injections or a single 2 mL device-free injection. UP0068 and UP0119 investigated the administration of bimekizumab with the SSy or AI devices given as a single 2 mL (BKZ-1 × 2 mL; 320 mg) or two 1 mL (BKZ-2 × 1 mL; 2 × 160 mg) subcutaneous injections, and were open-label, randomised, parallel-group, single-dose phase 1 studies.

The initial aim was to assess bioequivalence in a single study (UP0068). In UP0068, administration of bimekizumab subcutaneously via a single 2 mL SSy (BKZ-SSy-1 × 2 mL) versus two 1 mL SSy (BKZ-SSy-2 × 1 mL) and a single 2 mL AI (BKZ-AI-1 × 2 mL) versus two 1 mL AI (BKZ-AI-2 × 1 mL) were compared. Healthy participants were randomised in a 1:1:1:1 ratio to each single-dose treatment arm: BKZ-SSy-1 × 2 mL, BKZ-SSy-2 × 1 mL, BKZ-AI-1 × 2 mL, and BKZ-AI-2 × 1 mL, and injections were administered by a healthcare professional. Four hundred healthy male and female participants were planned to participate in the study; however, as a result of coronavirus disease 2019 (COVID-19) and several related lockdowns that delayed participant recruitment, the study was closed prematurely for operational reasons, finishing with 71 randomised participants. Consequently, UP0119 was conducted, and 121 healthy participants were randomised in a 1:1 ratio to receive BKZ-AI-1 × 2 mL and BKZ-AI-2 × 1 mL subcutaneously, delivered by a healthcare professional.

All studies were conducted in accordance with the principles of the Declaration of Helsinki and were approved by an independent review board and independent ethics committee. All participants provided informed written consent. Both studies were approximately 24 weeks in duration; participants returned to the clinic for assessments on predefined study days until the safety follow-up visit on day 140.

Full details of the participant inclusion and exclusion criteria for UP0068 and UP0119 are detailed in Table S2 (Supplementary Material).

Study Endpoints

Self-Injection Experience Studies (DV0002/DV0006)

The primary and secondary endpoints were the proportion of patients able to self-administer safe and effective bimekizumab 2 mL self-injections with either SSy or AI at week 8 (without further training) and baseline (immediately after training), respectively. This was defined as successful delivery of the entire dose of 2 mL (320 mg) bimekizumab, as confirmed by the visual inspection of the device by study personnel, and the absence of adverse device effects (ADEs; adverse events [AE] related to the use of an investigational device, per protocol) leading to withdrawal. For the study endpoints to be met, the single self-injection needed to be deemed safe and effective by the study personnel.

Pre- and post-self-injection experience was assessed using the SIAQ, described in more detail previously, which uses a 1–5 scale (ease of use domain: 1–6 scale), where a higher score reflected greater confidence and satisfaction, fewer concerns, and no injection site reactions [28]. Patients completed the pre-injection SIAQ at baseline, which included a total of seven items across three domains: ‘feelings about injections’, ‘self-confidence’, and ‘satisfaction with current mode of administration’. Within 30 min after each self-injection, patients completed the post-injection SIAQ, consisting of 21 items in total across six domains: ‘feelings about injections’, ‘self-image’, ‘self-confidence’, ‘injection site reactions’, ‘ease of use’, and ‘satisfaction with self-injection’. Patients assigned to the SSy and the AI completed versions 2.0 and 2.1 of the SIAQ, respectively. The pre- and post-injection SIAQ versions were identical, except for the 11th question in the post-injection SIAQ which discusses the use of a plunger (version 2.0; SSy) or depression of the device (version 2.1; AI). Individual item scores were transformed from a Likert-type scale rating of 1–5 (ease of use domain: 1–6 scale) to a 0–10 scale. This conversion allowed for comparison between items, domains, and questionnaires. Domain scores were calculated as a mean of the item scores if at least 50% of the items in the domain had been completed and also ranged from 0 to 10.

Injection site-related pain was measured within 15 min of completing the injection using a VAS; patients marked a line on a 100 mm scale, with 0 representing ‘no pain’ and 100 representing the ‘worst possible pain’. Additionally, post-use structural and functional integrity of the devices was evaluated by trained personnel after each self-injection.

Bioequivalence Studies (UP0068/UP0119)

For both UP0068 and UP0119, the following PK parameters were assessed as primary endpoints: area under the plasma concentration time curve from time zero to infinity (AUC), area under the plasma concentration time curve from time zero to the last quantifiable concentration (AUC0–t), and maximum observed plasma drug concentration (Cmax). Safety endpoints were treatment-emergent AEs, treatment-emergent serious AEs (SAEs), and ADEs.

Statistical Analysis

Self-Injection Experience Studies (DV0002/DV0006)

The median and range of the pre- and post-injection SIAQ domain scores, and VAS scores, were reported. AEs were recorded from the time of informed consent until study completion, and coded and classified by System Organ Class (SOC), high level term (HLT), and preferred term (PT) according to Version 19.0 of the Medical Dictionary for Regulatory Activities (MedDRA®). Only ADEs were documented in DV0002 and DV0006 while other AEs were recorded in a common database for BE BRIGHT, and reported in a previous publication [12]. Treatment-emergent ADEs were defined as events that occurred during or following the first self-administration of bimekizumab and up to 7 days following delivery of the final injection. Missing data were not imputed and observed case was used for the analysis.

Bioequivalence Studies (UP0068/UP0119)

Whole blood samples were collected to measure plasma concentration of bimekizumab at various timepoints across 140 days, after a single dose in all participants. Plasma concentrations of bimekizumab were determined using validated electrochemiluminescence immunoassays (ECLIA) based on a double‑antibody sandwich ligand binding assay using the Meso‑Scale Discovery (MSD) Sector Imager platform. PK parameters were derived via noncompartmental analysis of the bimekizumab plasma concentration–time profile using Phoenix® WinNonlin®. For PK parameters, summary statistics included geometric mean, geometric coefficient of variation, 95% confidence intervals (CIs) for the geometric mean, arithmetic mean, standard deviation (SD), median, minimum, and maximum.

Bioequivalence was evaluated on the primary PK parameters (AUC, AUC0–t, and Cmax) by an analysis of variance (ANOVA) model following loge transformation and included a fixed effect term for treatment. In UP0119, the study pair was also included as a fixed effect. For comparison of treatment arms, the difference between the least squares means (LSMs) was estimated and back transformed to obtain the geometric mean ratio (GMR) and associated 90% CI for the ratio. Bioequivalence was concluded if the 90% CIs for the ratio of the comparison were fully included in the acceptance range from 0.8 (80%) to 1.25 (125%) for AUC, AUC0–t, and Cmax.

All AEs were coded and categorised by relationship to bimekizumab; any AE with onset before study treatment or post 140 days after the dose was not considered treatment-emergent. An ADE was an AE related to the use of an investigational medical device, including any AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device, as well as any event resulting from use error or from intentional misuse of the investigation medical device.

Missing data were not imputed. The safety set was used for the patient demographic and safety analyses, whereas the PK set, a subset of the safety set, was used for the PK analysis.

Results

Self-Injection Experience Studies (DV0002/DV0006)

Patient Disposition and Baseline Characteristics

For full patient disposition in DV0002 and DV0006, see Fig. S3 (Supplementary Material), and for full details of the patient demographics and baseline characteristics, see Table 1.

Table 1.

Patient demographics and baseline characteristics in DV0002 and DV0006

DV0002 DV0006
BKZ-SSy-1 × 2 mL, n = 19 BKZ-AI-1 × 2 mL, n = 19 BKZ-SSy-1 × 2 mL, n = 44 BKZ-AI-1 × 2 mL, n = 45
Age (years), mean (SD) 50.3 (15.8) 43.0 (12.4) 46.0 (12.4) 48.3 (12.4)
Male, n (%) 10 (52.6) 10 (52.6) 31 (70.5) 34 (75.6)
White, n (%) 16 (84.2) 16 (84.2) 44 (100) 45 (100)
Weight (kg), mean (SD) 93.2 (30.9) 95.8 (23.9) 90.6 (18.0) 91.3 (17.9)
BMI (kg/m2), mean (SD) 32.4 (8.0) 33.3 (7.3) 29.6 (5.3) 29.9 (5.7)
Disease duration (years), mean (SD) 19.1 (13.0) 25.2 (14.4) 21.1 (11.5) 23.9 (12.8)
Country, n (%)
 Canada 11 (57.9) 7 (36.8) – –
 USA 8 (42.1) 12 (63.2) – –
 Germany – – 11 (25.0) 16 (35.6)
 Hungary – – 11 (25.0) 7 (15.6)
 Poland – – 22 (50.0) 22 (48.9)
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1 × 2 mL, a single 2 mL self-injection; AI, auto-injector; BKZ, bimekizumab; BMI, body mass index; SD, standard deviation; SSy: safety syringe

A total of 38 patients were randomised to either BKZ-SSy-1 × 2 mL (320 mg; n = 19) or BKZ-AI-1 × 2 mL (320 mg; n = 19) in DV0002; in the BKZ-AI-1 × 2 mL arm, one patient discontinued the sub-study as a result of anaemia (an AE not related to the device). Generally, patients’ baseline demographics and characteristics were similar between the two treatment arms in DV0002, except for mean age (SD) which was higher in the BKZ-SSy-1 × 2 mL group compared with the BKZ-AI-1 × 2 mL group (50.3 [15.8] versus 43.0 [12.4]) and mean disease duration (SD) which was higher in the BKZ-AI-1 × 2 mL group (25.2 years [14.4] versus 19.1 years [13.0]) compared with the BKZ-SSy-1 × 2 mL group.

A total of 89 patients were randomised to receive either BKZ-SSy-1 × 2 mL (n = 44) or BKZ-AI-1 × 2 mL (n = 45) in DV0006; one patient in the BKZ-SSy-1 × 2 mL arm withdrew consent and did not complete the study, and was not included in the analysis. The patient baseline demographics were consistent between the BKZ-SSy-1 × 2 mL and BKZ-AI-1 × 2 mL groups.

Safe and Effective Self-Injection

In DV0002, at baseline, all 38 patients in both groups (BKZ-SSy-1 × 2 mL, 100%; and BKZ-AI-1 × 2 mL, 100%) were able to administer safe and effective self-injections. All 19 (100%) patients in the BKZ-SSy-1 × 2 mL group and 18/19 (94.7%) patients in the BKZ-AI-1 × 2 mL group were able to administer safe and effective self-injections at week 8. The one patient that did not administer a safe and effective self-injection in the BKZ-AI-1 × 2 mL group injected an incomplete dose as a result of an ADE (injection site pain) that was mild, not serious, and did not lead to discontinuation.

In DV0006, all 44 (100%) and 45 (100%) patients in the BKZ-SSy-1 × 2 mL and BKZ-AI-1 × 2 mL groups, respectively, were able to self-administer safe and effective injections at baseline and week 8.

SIAQ

In both DV0002 and DV0006, patients reported a positive self-injection experience with the devices including patient satisfaction, confidence, and ease of use.

The acceptability of self-injection was high at baseline prior to injections with the BKZ-SSy-1 × 2 mL or BKZ-AI-1 × 2 mL devices. SIAQ scores were also high post-injection at baseline and week 8 in DV0002 (Fig. 1) and DV0006 (Fig. 2) for both devices. At baseline, median pre-injection SIAQ subscale score for “satisfaction with current mode of administration” was 10.0 for both BKZ-SSy-1 × 2 mL and BKZ-AI-1 × 2 mL subgroups of patients, in DV0002. For DV0006, median subscale scores were 10.0 for BKZ-SSy-1 × 2 mL and 7.5 for BKZ-AI-1 × 2 mL.

Fig. 1.

Fig. 1

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Self-Injection Assessment Questionnaire (SIAQ) responses pre-injection at baseline and post-injection at baseline and week 8 in DV0002: i) bimekizumab delivered via a single 2 mL self-injection using a safety syringe (BKZ-SSy-1 × 2 mL) and ii) BKZ delivered via 1 × 2 mL using an auto-injector (BKZ-AI-1 × 2 mL) (observed case [OC]). an=16 at the post-injection Week 8 visit. For pre-injection SIAQ at baseline, patients were also asked about their “satisfaction with current mode of administration”, which is not reported here as it does not relate to the SSy or AI. Median values are shown. 1 × 2 mL a single 2 mL self-injection, AI auto-injector, BKZ bimekizumab, OC observed case, SIAQ Self-Injection Assessment Questionnaire, SSy safety syringe

Fig. 2.

Fig. 2

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Self-Injection Assessment Questionnaire (SIAQ) responses pre-injection at baseline and post-injection at baseline and week 8 in DV0006: i) bimekizumab delivered via a single 2 mL self-injection using a safety syringe (BKZ-SSy-1 × 2 mL) and ii) BKZ delivered via 1 × 2 mL using an auto-injector (BKZ-AI-1 × 2 mL) (observed case [OC]). For pre-injection SIAQ at baseline, patients were also asked about their “satisfaction with current mode of administration”, which is not reported here as it does not relate to the SSy or AI. Median values are shown. 1 × 2 mL a single 2 mL self-injection, AI auto-injector, BKZ bimekizumab, OC observed case, SIAQ Self-Injection Assessment Questionnaire, SSy safety syringe

In DV0002, at baseline and week 8 post-injection with BKZ-SSy-1 × 2 mL, the median SIAQ score for all subscales was ≥ 7.5 (high scores = higher satisfaction; scale 0–10). When BKZ-AI-1 × 2 mL was used, the median SIAQ score for all subscales post-injection was ≥ 9.3 at baseline and ≥ 8.3 at week 8. Similarly, in DV0006, the median SIAQ score for all subscales was ≥ 7.5 for the BKZ-SSy-1 × 2 mL and BKZ-AI-1 × 2 mL groups at baseline and week 8.

Pain VAS

After self-injection using the BKZ-SSy-1 × 2 mL or the BKZ-AI-1 × 2 mL in DV0002, injection-related pain scores were variable between the devices but generally low at both baseline and week 8 (all ≤ 11.5/100) (Fig. 3i). In the BKZ-SSy-1 × 2 mL and BKZ-AI-1 × 2 mL groups, the median VAS scores were 6.0 and 11.5, respectively, at baseline, and 2.0 and 10.5, respectively, at week 8. Pain scores were consistent for the BKZ-AI-1 × 2 mL group at baseline and week 8 (11.5 vs 10.5, respectively), but variable for the BKZ-SSy-1 × 2 mL group (6.0 vs 2.0). Similarly, in DV0006, injection-related pain scores after self-injection with the BKZ-SSy-1 × 2 mL or BKZ-AI-1 × 2 mL were variable between the devices but generally low. Pain scores were consistent between baseline and week 8 for the BKZ-SSy-1 × 2 mL and BKZ-AI-1 × 2 mL groups; the median VAS scores were 5.5 and 12.0, respectively, at baseline, and 7.0 and 10.0, respectively, at week 8 (Fig. 3ii). Pain scores were also consistent for each group at baseline and week 8.

Fig. 3.

Fig. 3

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Injection site-related pain visual analogue scale (VAS) at baseline and week 8 in i) DV0002 and ii) DV0006 (observed case [OC]). OC observed case, VAS visual analogue scale

Structural Integrity and Functionality

None of the devices in either DV0002 (38 BKZ-SSy-1 × 2 mL and 38 BKZ-AI-1 × 2 mL) or DV0006 (88 BKZ-SSy-1 × 2 mL and 90 BKZ-AI-1 × 2 mL) were reported to show any signs of post-use structural integrity issues or functional compromise. Both device presentations functioned as intended.

Safety

Self-injection with the BKZ-SSy-1 × 2 mL and BKZ-AI-1 × 2 mL was well tolerated in DV0002 and DV0006. Two ADEs were reported in DV0002: both were injection site reaction AEs (one patient each in the BKZ-SSy-1 × 2 mL and BKZ-AI-1 × 2 mL device groups). Neither event was serious, severe, or led to study discontinuation, and both were resolved. No ADEs or injection site reactions were reported in DV0006.

Bioequivalence Studies (UP0068/UP0119)

Participant Disposition and Baseline Characteristics

For full participant disposition in UP0068 and UP0119, see Fig. S4 (Supplementary Material), and for full details of the baseline demographics and characteristics, see Table 2.

Table 2.

Participant demographics and baseline characteristics in UP0068 and UP0119

UP0068 UP0119
BKZ-SSy-1 × 2 mL, n = 18 BKZ-Ssy-2 × 1 mL, n = 18 BKZ-AI-1 × 2 mL, n = 17 BKZ-AI-2 × 1, n = 18 BKZ-AI-1 × 2 mL, n = 60 BKZ-AI-2 × 1 mL, n = 61
Age (years), mean (SD) 52.6 (12.8) 51.1 (15.8) 46.8 (15.7) 46.7 (15.7) 45.6 (11.7) 44.8 (11.3)
Male, n (%) 6 (33.3) 5 (27.8) 4 (23.5) 5 (27.8) 36 (60.0) 37 (60.7)
White, n (%) 17 (94.4) 17 (94.4) 17 (100.0) 18 (100.0) 50 (83.3) 50 (82.0)
Weight (kg), mean (SD) 68.7 (12.9) 68.4 (10.3) 68.5 (10.7) 72.9 (12.8) 77.1 (12.5) 76.5 (12.3)
BMI (kg/m2), mean (SD) 23.9 (3.5) 23.7 (3.5) 24.0 (3.4) 25.1 (3.3) 26.0 (2.5) 25.5 (3.0)
Country, n (%)
 Germany 18 (100.0) 18 (100.0) 17 (100.0) 18 (100.0) 33 (55.0) 34 (55.7)
 USA – – – – 27 (45.0) 27 (44.3)
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1 × 2 mL a single 2 mL injection, 2 × 1 mL two 1 mL injections, AI auto-injector, BKZ bimekizumab, BMI body mass index, SD standard deviation, SSy safety syringe

A total of 71 participants, randomised across four arms (SSy-1 × 2 mL [n = 18], SSy-2 × 1 mL [n = 18], AI-1 × 2 mL [n = 17], and AI-2 × 1 mL [n = 18]), were enrolled in UP0068. All randomised participants completed the study. Overall, participant baseline demographics were similar between the four treatment arms in UP0068, except for mean weight (kg [SD]) which was slightly higher in the BKZ-AI-2 × 1 mL group (72.9 kg [12.8]) compared to the BKZ-SSy-1 × 2 mL (68.7 kg [12.9]), BKZ-SSy-2 × 1 mL (68.4 kg [10.3]), and BKZ-AI-1 × 2 mL (68.5 kg [10.7]) groups.

In UP0119, a total of 121 participants were enrolled and randomised to BKZ-AI-1 × 2 mL (n = 60) and BKZ-AI-2 × 1 mL (n = 61). One participant in the BKZ-AI-2 × 1 mL treatment group discontinued on day 2 and was replaced. A total of 118 participants completed the study (BKZ-AI-1 × 2 mL [n = 59] and BKZ-AI-2 × 1 mL [n = 59]); two participants were lost to follow-up (1.7%) and one participant withdrew consent (not due to AE; 0.8%). There were missing data for two participants in the BKZ-AI-2 × 1 mL treatment arm as AUC and AUC0–t parameters were not calculable and thus were excluded from the analysis (n = 59). Participant baseline demographics were similar between BKZ-AI-1 × 2 mL and BKZ-AI-2 × 1 mL groups in UP0119.

Pharmacokinetics

For UP0068, the geometric mean (with 95% CI) plasma concentrations of bimekizumab were consistent between the BKZ-SSy-1 × 2 mL and BKZ-SSy-2 × 1 mL groups (Fig. 4i). Geometric mean AUC, AUC0–t, and Cmax were similar between the two BKZ-SSy-1 × 2 mL and BKZ-SSy-2 × 1 mL groups (Table 3). The geometric mean ratio (90% CIs) of BKZ-SSy-1 × 2 mL and BKZ-SSy-2 × 1 mL groups, as measured by AUC, AUC0–t, and Cmax, was 103.4% (86.4, 123.8), 102.8% (87.0, 121.5), and 104.0% (90.3, 119.7), respectively. Bioequivalence was demonstrated between the BKZ-SSy-1 × 2 mL and BKZ-SSy-2 × 1 mL groups, as the 90% CIs for the ratios of AUC, AUC0–t, and Cmax fell entirely within the acceptance range of 80.0 to 125.0.

Fig. 4.

Fig. 4

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Geometric mean (with 95% CI) plasma concentrations versus scheduled time for i) bimekizumab delivered via a single 2 mL injection using a safety syringe (BKZ-SSy-1 × 2 mL; n = 18) and BKZ delivered via two 1 mL injections using an SSy (BKZ-SSy-2 × 1 mL; n = 18), and ii) BKZ delivered via a single 2 mL injection using an auto-injector (BKZ-AI-1 × 2 mL; n = 17) and BKZ delivered via two 1 mL injections using an AI (BKZ-AI-2 × 1 mL; n = 18) in UP0068. 1 × 2 mL a single 2 mL injection, 2 × 1 mL, two 1 mL injections, AI auto-injector, BKZ bimekizumab, CI confidence interval, SSy safety syringe

Table 3.

Bioequivalence outcomes reported for UP0068, comparing bimekizumab delivered via a single 2 mL injection using a safety syringe (BKZ-SSy-1 × 2 mL) with BKZ delivered via two 1 mL injections using an SSy (BKZ-SSy-2 × 1 mL) and BKZ delivered via a single 2 mL injection using an auto-injector (BKZ-AI-1 × 2 mL) with BKZ delivered via two 1 mL injections using an AI (BKZ-AI-2 × 1 mL)

BKZ-SSy-1 × 2 mL, n = 18 BKZ-SSy-2 × 1 mL, n = 18 BKZ-AI-1 × 2 mL, n = 17 BKZ-AI-2 × 1 mL, n = 18
Parameter Geo LSM (90% CI) Geo LSM (90% CI) GMR (90% CI) Geo LSM (90% CI) Geo LSM (90% CI) GMR (90% CI)
AUC (day·μg/mL) 1665 (1466.2, 1891.2) 1610 (1417.5, 1828.4) 103.4 (86.4, 123.8)* 1560 (1390.5, 1750.0) 1357 (1213.4, 1517.3) 115.0 (97.9, 135.0)
AUC0–t (day·μg/mL) 1551 (1377.8, 1745.6) 1509 (1340.4, 1698.2) 102.8 (87.0, 121.5)* 1469 (1317.9, 1637.6) 1296 (1166.0, 1439.9) 113.4 (97.4, 131.9)
Cmax (μg/mL) 43.6 (39.4, 48.1) 41.9 (37.9, 46.3) 104.0 (90.3, 119.7)* 42.2 (38.2, 46.7) 36.9 (33.5, 40.7) 114.3 (99.5, 131.4)
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Geometric mean ratio (GMR) calculated as (parameter for 1 × 2 mL BKZ/parameter for 2 × 1 mL BKZ) × 100. Asterisks indicate bioequivalence has been demonstrated since the 90% confidence internal (CI) ratios fall within the 80.0–125.0% acceptance range

1 × 2 mL a single 2 mL injection, 2 × 1 mL two 1 mL injections, AI auto-injector, AUC area under the plasma concentration–time curve from time 0 to infinity, AUC0–t AUC to last non-zero concentration, BKZ bimekizumab, CI confidence interval, Cmax maximum observed plasma drug concentration, Geo geometric, GMR geometric mean ratio, LSM least squares mean, SSy safety syringe

The geometric mean (with 95% CI) plasma concentrations of bimekizumab were consistently higher for the BKZ-AI-1 × 2 mL group compared with the BKZ-AI-2 × 1 mL group in UP0068 (Fig. 4ii). The geometric mean ratios (90% CIs) of BKZ-AI-1 × 2 mL and BKZ-AI-2 × 1, as measured by AUC, AUC0–t, and Cmax were 115.0 (97.9, 135.0), 113.4 (97.4, 131.9), and 114.3 (99.5, 131.4), respectively (Table 3). As the 90% CIs for the ratios of AUC, AUC0–t, and Cmax fell outside of the acceptance range of 80.0 to 125.0, bioequivalence was not demonstrated. As UP0068 had to close prematurely and did not reach participant enrolment targets, this led to the development of UP0119 where bioequivalence was tested again between the BKZ-AI-1 × 2 mL and BKZ-AI-2 × 1 mL groups.

UP0119 recruited the planned sample size (n = 120), was completed, and demonstrated robust results, fulfilling the predefined bioequivalence limits as described in regulatory guidelines [29, 35, 36]. The geometric mean (with 95% CI) plasma concentrations of bimekizumab were consistent between the BKZ-AI-1 × 2 mL and BKZ-AI-2 × 1 mL injections (Fig. 5). The geometric mean AUC, AUC0–t, and Cmax values were consistent between the BKZ-AI-1 × 2 mL and BKZ-AI-2 × 1 mL groups (Table 4). The geometric mean ratio (90% CIs) of bimekizumab, as measured by AUC, AUC0–t, and Cmax, was 97.5% (90.2, 105.4), 97.1% (90.1, 104.6), and 96.2% (88.6, 104.5), respectively. Bioequivalence was demonstrated between BKZ-AI-1 × 2 mL and BKZ-AI-2 × 1 mL as the 90% CIs for this comparison fell entirely within the acceptance range of 80.0 to 125.0 for the PK parameters AUC, AUC0–t, and Cmax.

Fig. 5.

Fig. 5

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Geometric mean (with 95% CI) plasma concentrations versus scheduled time of bimekizumab delivered via a single 2 mL injection using an auto-injector (BKZ-AI-1 × 2 mL; n = 60) and BKZ delivered via two 1 mL injections using an AI (BKZ-AI-2 × 1 mL; n = 61) in UP0119. 1 × 2 mL a single 2 mL injection, 2 × 1 mL two 1 mL injections, AI auto-injector, BKZ bimekizumab, CI confidence interval

Table 4.

Bioequivalence outcomes reported for UP0119, comparing bimekizumab delivered via a single 2 mL injection using an auto-injector (BKZ-AI-1 × 2 mL) with BKZ delivered via two 1 mL injections using an auto-injector (BKZ-AI-2 × 1 mL)

BKZ-AI-1 × 2 mL, n = 60 BKZ-AI-2 × 1 mL, n = 59
Parameter Geo mean (95% CI) Geo mean (95% CI) GMR (90% CI)
AUC (day·μg/mL) 1223 (1146.1, 1306.1) 1255 (1174.2, 1341.1) 97.5 (90.2, 105.4)*
AUC0–t (day·μg/mL) 1186 (1114.7, 1262.9) 1223 (1147.3, 1302.6) 97.1 (90.1, 104.6)*
Cmax (μg/mL) 35.2 (32.8, 37.7) 36.6 (34.1, 39.2)a 96.2 (88.6, 104.5)*
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aFull cohort (n = 61). Geometric mean ratio (GMR) calculated as (parameter for 1 × 2 mL BKZ/parameter for 2 × 1 mL BKZ) × 100. Asterisks values indicate bioequivalence has been demonstrated since the 90% confidence interval (CI) ratios fall within the 80.0–125.0% acceptance range. As a result of early discontinuation, there were missing data for two participants in the BKZ-AI-2 × 1 mL treatment arm as area under the plasma concentration–time curve from time 0 to infinity (AUC) and AUC to last non-zero concentration (AUC0–t) parameters were not meaningful and thus were excluded from the analysis

1 × 2 mL a single 2 mL injection, 2 × 1 mL two 1 mL injections, AI auto-injector, AUC area under the plasma concentration–time curve from time 0 to infinity, AUC0–t AUC to last non-zero concentration, BKZ bimekizumab, CI confidence interval, Cmax maximum observed plasma drug concentration, Geo geometric, GMR geometric mean ratio

Safety

Bimekizumab was generally well tolerated in UP0068 and UP0119 and revealed no new safety concerns on the basis of the existing acceptable safety profile of bimekizumab.

TEAEs (any) occurred in both studies (Table S3, Supplementary Material). The most commonly reported TEAEs in UP0068 (full analysis set, n = 71 [SSy-1 × 2 mL, n = 18; SSy-2 × 1 mL, n = 18; AI-1 × 2 mL, n = 17; AI-2 × 1 mL, n = 18]) were musculoskeletal and connective tissue disorders (n = 14) and nervous system disorders (n = 14), whereas in UP0119 (safety set, n = 121 [AI-1 × 2 mL, n = 60; AI-2 × 1 mL, n = 61]) they were infections and infestations (n = 24) and nervous system disorders (n = 18). There were no serious TEAEs, severe TEAEs, or TEAEs leading to discontinuation or death in UP0068 or UP0119.

In UP0068, one participant in the BKZ-SSy-1 × 2 mL and one participant in the BKZ-AI-1 × 2 mL treatment group reported an ADE; these were an injection site haematoma and injection site pain, respectively. Three participants in the BKZ-AI-2 × 1 mL treatment group also reported an ADE, two reported injection site haematoma and one reported pain in extremity and injection site haematoma. One participant in the BKZ-AI-1 × 2 mL treatment group in UP0119 reported a non-serious ADE of injection site pain. Across UP0068 and UP0119, all ADEs reported were mild, non-serious, did not lead to discontinuation and were resolved.

Discussion

Patients using self-injection have reported a variety of barriers with this method of treatment administration, including anxiety and fear of needles [7, 37, 38]. When coupled with differing preferences for self-injection design features and delivery methods among patients, having a selection of self-injection devices to choose from on the basis of personal preference may help patients to overcome the psychological barriers to self-injection [27, 39, 40]. Patients with moderate to severe plaque psoriasis were able to safely and effectively self-inject bimekizumab using both devices for a single 2 mL (320 mg) self-injection at 8 weeks and baseline, meaning both the primary and secondary objectives were met, respectively. Overall, patients reported positive self-injection experiences and low injection-related pain scores, regardless of the device. All pain scores were mild to no pain, according to VAS scale categories presented in Bodian et al. and Jensen et al.; however, the VAS scale categories were not presented to patients during measurement of injection site-related pain in DV0002 and DV0006 [41, 42]. The two ADEs reported in DV0002 were mild and did not lead to study discontinuation; no ADEs were reported in DV0006. These findings demonstrate that DV0002 and DV0006 support the use of the 2 mL SSy and AI devices as alternative treatment options for self-injection for patients with moderate to severe plaque psoriasis. The results could also have implications for patients with HS, for whom the indicated dose of bimekizumab is 320 mg, currently delivered via two 160 mg injections with 1 mL devices [19, 43].

Patients who have more treatment choices, such as different delivery methods, have previously reported improved self-injection experiences, which also has the potential to improve treatment adherence [39, 44, 45]. This is particularly important for patients with arthritis in their hands or wrists; estimates vary, but up to 30% of patients with psoriasis will develop psoriatic arthritis [46–49]. This subpopulation of patients may particularly benefit from only delivering one injection rather than two, since symptoms of arthritis may impact their grip and pinch strength which could affect their ability to deliver self-injections [50–52]. Furthermore, patient choice extends beyond selecting a device on the basis of personal preference or specific needs; it empowers patients to be involved with their treatment plans and healthcare decisions, a desire that has previously been expressed by patients [39]. The desire to alleviate the pain of injection has also been highlighted in experiences of patients with chronic disease, with injection site pain also contributing to a reduction in medication adherence [39, 53, 54].

The outcomes reported here were consistent with the findings of Bagel et al., where both the SSy and the AI were used for two 1 mL self-injections by patients with moderate to severe plaque psoriasis [7]. When results from Bagel et al. and this current study were compared, pain scores were numerically lower with one 2 mL injection compared to two 1 mL injections, and SIAQ scores, including satisfaction with self-injection, were similar, reflecting a similar self-injection experience [7]. Injection site pain is a significant barrier to self-injection, and so the low pain scores reported in this study further emphasise the potential benefits of these devices to patients [55].

Beyond the similar self-injection experience reported for the two 1 mL and single 2 mL self-injection devices, there was also no notable difference in the PK observed when bimekizumab was administered either as a single 2 mL or two 1 mL subcutaneous injections for both SSy and AI devices. The assessment of bioequivalence was performed following regulatory guidance [29, 35, 36]. For UP0068, bioequivalence was assessed using two one-sided tests at a 5% significance level. Despite operational challenges that arose from conducting the trial during the COVID-19 pandemic that meant that the study was closed prematurely, at least 17 participants per arm were included, which exceeded the minimum number of 12 evaluable subjects that is outlined in the guidance [29, 35, 36]. In general, a study with fewer than the total number of planned participants reduces the likelihood of establishing bioequivalence if the true ratio of PK parameters is between 80% and 125%. However, it would not affect the probability of a false positive result (type I error) i.e. the chance of truly non-bioequivalent test treatment achieving bioequivalence. Therefore, the results of UP0068 confirmed that the 2 mL SSy can be considered therapeutically equivalent to the approved 1 mL device, but necessitated the conduct of UP0119 to confirm bioequivalence of the AI devices; this means these studies support the use of the 2 mL SSy and AI devices [29]. Delivery of bimekizumab via a single dose self-injection device is in line with the device options for secukinumab and risankizumab, other biologic treatments for moderate to severe plaque psoriasis, which both offer an SSy and AI single dose self-injection option [56–58].

Limitations

A small number of patients were recruited for the self-injection experience studies and received only two bimekizumab self-injections. Therefore, the findings may not be applicable to a broader population of patients using bimekizumab self-injection devices over an extended period. Mean age and mean disease duration differed between the SSy and AI study arms in DV0002. Additionally, patient demographics and baseline characteristics differed between DV0002 and DV0006. Given results were generally consistent between groups and across studies, the perceived impact of these differences is expected to be minimal. An individual’s perception of pain is complex, impacted by a combination of biological, psychological, and socio-cultural factors, and so this could have led to variability in the self-injection pain scores between devices [59].

Operational challenges that arose from conducting UP0068 during the COVID-19 pandemic meant that the study was closed prematurely, enrolling 71 of 400 participants at the time of termination. As a result, bioequivalence was not demonstrated for the 2 mL AI device. The difference in the baseline characteristics for body weight in the AI groups in UP0068 could have also partly contributed to why bioequivalence was not demonstrated for the BKZ-AI-1 × 2 mL and BKZ-AI-2 × 1 mL groups.

Finally, the studies reported here may not be fully reflective of real-world situations for patients as they were carried out in a controlled clinical trial context.

Conclusion

Patients reported the 2 mL SSy and AI devices for bimekizumab (320 mg) safe and effective, with positive self-injection experience and low injection site pain. These devices have been shown to deliver the same dose as two 1 mL injections (2 × 160 mg) without significant differences in PK. Both devices offer a convenient option for patients living with moderate to severe plaque psoriasis; they may also benefit patients with HS, who are also treated with the same dose of bimekizumab (320 mg). This allows for personalised device choice in collaboration with healthcare professionals.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PDF 367 KB) (390KB, pdf)

Acknowledgements

The authors thank the participants who took part in these studies. The authors would also like to thank the investigators and their teams, including Dr Dennis Ruff, MD, Dr Rainard Fuhr, MD, and Dr Ronald Vender, MD. The authors also acknowledge Inés Dueñas Pousa, PhD, UCB, Spain, for publication coordination, Daljit Tatla, UCB, for contribution to DV0002 and DV0006, and Francesca Lewns, PhD, and Olivia Edwards, BSc, from Costello Medical, UK, for medical writing and editorial assistance based on the authors’ input and direction; support for this assistance was funded by UCB. All included studies were funded by UCB.

Medical Writing/Editorial Assistance

The authors acknowledge Francesca Lewns, PhD, and Olivia Edwards, BSc, from Costello Medical, UK, for medical writing and editorial assistance based on the authors’ input and direction; support for this assistance was funded by UCB.

Author Contributions

Substantial contributions to study conception and design: Michael Sebastian, Jerry Bagel, Bengt Hoepken, Bertram Knapp, Ceyhun Bicer, Merran MacPherson, Richard G. Langley; substantial contributions to analysis and interpretation of the data: Michael Sebastian, Jerry Bagel, Bengt Hoepken, Bertram Knapp, Ceyhun Bicer, Merran MacPherson, Richard G. Langley; drafting the article or revising it critically for important intellectual content: Michael Sebastian, Jerry Bagel, Bengt Hoepken, Bertram Knapp, Ceyhun Bicer, Merran MacPherson, Richard G. Langley; final approval of the version of the article to be published: Michael Sebastian, Jerry Bagel, Bengt Hoepken, Bertram Knapp, Ceyhun Bicer, Merran MacPherson, Richard G. Langley.

Funding

This article was based on the original studies BE BRIGHT (NCT03598790), UP0068, and UP0119, all of which were sponsored by UCB. Support for third-party writing assistance for this article, provided by Francesca Lewns, PhD, and Olivia Edwards, BSc, Costello Medical, UK, was funded by UCB in accordance with Good Publication Practice (GPP) guidelines (https://www.ismpp.org/gpp-2022). The journal’s Rapid Service Fee was funded by UCB. Funding for the creation and publication of the graphical abstract was from the same source as the original manuscript.

Data Availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Underlying data from this manuscript may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymised individual participant-level data and redacted trial documents, which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at http://www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Declarations

Conflict of Interest

Michael Sebastian: Cooperations with the following companies: AbbVie, Affibody, Allergan, Alumis, Almirall, Apogee, AstraZeneca, August Wolff, Boehringer Ingelheim, Bristol Myers Squibb, Dermapharm, Dermira, Galderma, Incyte, Ipsen, Janssen-Cilag, LEO Pharma, MedImmune, Menlo Therapeutics, Moonlake, MSD, Mundipharma, Novartis, Pfizer, Regeneron, Sanofi, Takeda, and UCB Pharma; Jerry Bagel: Speaker, investigator and/or consultant for AbbVie, Celgene, Eli Lilly and Company, LEO Pharma, Novartis, Ortho Dermatologics; research funds payable to Psoriasis Treatment Center from AbbVie, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, CorEvitas, Dermavant Sciences, Dermira, Eli Lilly and Company, Glenmark Pharmaceuticals, Janssen, Kadmon Corporation, LEO Pharma, Lycera, Menlo Therapeutics, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sun Pharma, Taro, and UCB; consultant fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis, Sun Pharma, and UCB; and fees for speaking from AbbVie, Celgene, Eli Lilly and Company, Janssen, and Novartis; Bengt Hoepken, Bertram Knapp, Merran MacPherson: employees of UCB; Ceyhun Bicer: statistical consultant at UCB; Richard G. Langley: Principal investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, LEO Pharma, Merck, Novartis, Pfizer, and UCB Pharma; served on scientific advisory boards for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, LEO Pharma, Merck, Novartis, Pfizer, and UCB Pharma; provided lectures for AbbVie, Amgen, Celgene, Eli Lilly, LEO Pharma, Merck, Novartis, and Pfizer.

Ethical Approval

All studies were conducted in accordance with the principles of the Declaration of Helsinki and were approved by an independent review board and independent ethics committee. All participants provided informed written consent. All the results presented in this article are in aggregate form, and no personally identifiable information was used for this study.

Footnotes

Prior Presentation: Bimekizumab safe and effective self-administration using 2 mL devices by patients with moderate to severe plaque psoriasis: Results from two multicentre, randomised, open-label studies, by Bagel J, Knapp B, Vaux T, Hoepken B, and Sebastian M, was previously presented at the 33rd European Academy of Dermatology and Venereology Congress, in Amsterdam, the Netherlands, 25–28 September 2024.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplementary file1 (PDF 367 KB) (390KB, pdf)

Data Availability Statement

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Underlying data from this manuscript may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymised individual participant-level data and redacted trial documents, which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at http://www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

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