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The safety syringe and auto-injector provide patients with psoriasis with 2 options for the self-administration of bimekizumab.
A recent investigation into self-injections of bimekizumab through a 1 mL safety syringe or auto-injector found that both devices provided a safe and effective option for patients with plaque psoriasis to self-administer the medication.
Investigators noted that biologics are often administered subcutaneously via self-injection, which offers patients the benefit of having control over the injection setting and schedule. Self-injection also reduces costs for the healthcare system, with patients no longer needing to visit hospitals or clinics for routine injections.
Needle phobia and a lack of confidence have led to complications regarding self-injection. However, the design of self-injection devices have aided patients in overcoming these fears.
As such, Jerry Bagel, MD, Psoriasis Treatment Center of Central New Jersey, East Windsor, and a team of investigators evaluated the ability of patients with plaque psoriasis to self-inject bimekizumab using the safety syringe or the auto-injector.
The primary and secondary objectives established for the study were to evaluate each device for the ability of patients to self-administer bimekizumab 8 weeks safely and effectively after receiving training in self-injection and immediately after training, respectively.
Additional objectives included evaluating patient experience of self-injection via the pain visual analog scale (VAS) and the Self-Injection Assessment Questionnaire (SIAW) as well as the structural and mechanical integrity of each device.
Participants were previously enrolled in sub-studies of the BE BRIGHT trial, which was an open-label extension of 3 phase 3 randomized control studies. All patients involved in the present study were 18 years and older who were diagnosed with moderate-to-severe plaque psoriasis, willing to self-inject bimekizumab, and considered reliable and capable of adhering to the protocol by the investigator.
The bimekizumab safety syringe was designed with an extended finger flange and plunger rod with a soft grip thumb area, while the bimekizumab auto-injector was designed with a large grip area to facilitate manipulation of the device, and included a hidden needle and a window where the contents of the enclosed syringe could be seen.
Patients received bimekizumab 320 mg every 4 week or every 8 weeks depending on the Psoriasis Area Severity Index (PASI) score achieved in the feeder trials.
At baseline, patients were randomized 1:1 to the safety syringe or auto-injector group and received training on self-injection technique for their assigned device.
Patients self-injected at baseline immediately after training and at week 8, while other injections of bimekizumab were administered by study personnel.
Among the 134 patients enrolled in the study, 66 were randomized to the safety syringe while 68 were randomized to the auto-injector arm. Only 1 patient randomized to the safety syringe arm did not perform any self-injections and was excluded from subsequent analysis sets.
Among patients randomized to the safety syringe arm, 98.5% (64/65) completed the study, with 64 and 63 evaluable patients at Baseline and Week 8, respectively.
Of the patients randomized to the auto-injector arm, 89.7% (61/68) completed the study with 68 and 62 evaluable patients at Baseline and Week 8, respectively.
Bagel and colleagues observed that 100% of evaluable patients who used the safety syringe (n=63) and the auto-injector (n=62) were able to safely and effectively self-inject bimekizumab at Week 8 , and 100% of evaluable patients who used the safety syringe (n=64) and 97.1% of evaluable patients (n=66/68) who used the auto-injector were able to safely and effectively self-inject bimekizumab immediately after training at baseline.
Of the 254 safety syringes used in the study, none showed signs of impaired structural integrity, product quality, or functional compromise. Of the 258 auto-injectors used, 2 (0.8%) showed signs of functional compromise during inspection after the first self-injection at Baseline.
“The safety syringe and auto-injector provide patients with psoriasis two options for the self-administration of bimekizumab that are safe, effective and associated with an overall positive self-administration experience,” the team wrote. “By providing both options, patients have the choice to use the device that best suits their preferences on the level of control over the self-injection process.”