Usability validation of the Sensoready® pen in patients with relapsing multiple sclerosis.

Background: The Sensoready® pen is intended for self-administration of subcutaneous 20 mg ofatumumab at home. This human factors summative study assessed the usability of the Sensoready pen in relapsing multiple sclerosis patients. Methods: 32 patients (injection-experienced [n = 17] and injection-naive [n = 15]) across five locations in the USA were asked to complete two simulated injections using the Sensoready pen. Results: In the first and second simulated injections, 90.6 and 96.9% of patients, respectively, successfully delivered a full dose, while 81.3 and 84.4%, respectively, successfully performed the injection without any use errors. Conclusion: The Sensoready pen is safe and effective for its intended use by intended users and in the intended use environment. This pen has a low harm potential and high injection success rate in patients, even without prior training or experience.

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

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.6274THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Efficacy of a 28-compartment pillbox for improving iron supplement compliance in healthy pregnant women: a randomised controlled trial.

A randomised controlled trial was conducted. The primary objective was to evaluate the efficacy of a pillbox for increasing iron supplement compliance by comparing the proportion of pregnant women who had no remaining iron tablets between pregnant women attending ANC who were given a pillbox to use and women with no pillbox in four-week period between ANC visits. The secondary objective was to evaluate the reasons for poor compliance and possible factors associated with the non-compliance. One hundred and ninety pregnant women were enrolled, 95 participants were randomised into each of the groups. The proportion of pregnant women who had no remaining iron tablets at the end was statistically significantly lower in the pillbox group than in the control group [53.3% and 23.1%, respectively, p < .001, RR2.308 (95% CI 1.515 - 3.517)]. The most common reason given for having of iron tablets remaining was forgetfulness. The visual analog scale (VAS) scores indicated that patient's responsibility feeling, duration of sleep each day and presence of a handicapped or small child in care significantly influenced the proportion of pregnant women who had remaining iron tablets at the end in both groups. We concluded that a pillbox was found to be an effective tool for improving pregnant women's compliance with taking their iron supplements.IMPACT STATEMENTWhat is already known about this subject? Antenatal care (ANC) influences maternal and neonatal outcomes. The incidence of anaemia in pregnant women is reported to be around 42% and approximately 50% result from iron deficiency. Maternal anaemia increases the risk of foetal low birth weight, preterm birth, perinatal mortality, stillbirth and maternal mortality.What do the results of this study add? The 28-compartment pillbox is effective for improving iron supplement compliance in healthy pregnant women. Forgetfulness is the most common reason given for having remaining iron tablets. The lower score on the visual analog scale of patient's feeling of responsibility, long duration of sleep a day and the presence of a handicapped or small child in their care were significantly associated with having remaining iron tablets.What are the implications are of these finding for clinical practice and/or further research? The 28-compartment pillbox can be implied to routine antenatal care for improving iron supplement compliance in healthy pregnant women. Health care providers should be reminded to encourage compliance with iron supplement prescription in pregnant women who are at risk of poor compliance as indicated by low VAS of the patient's feeling of responsibility, long duration of sleep in a day and pregnant women who have responsibility to take care of handicapped or small children.

Self-administration of adrenaline for anaphylaxis during in-hospital food challenges improves health-related quality of life.

OBJECTIVE: To assess the impact of anaphylaxis on health-related quality of life (HRQL) and self-efficacy in food-allergic patients undergoing in-hospital food challenge. DESIGN: Secondary analysis of a randomised controlled trial. SETTING: Specialist allergy centre. PATIENTS: Peanut-allergic young people aged 8-16 years. INTERVENTIONS: Double-blind, placebo-controlled food challenge to peanut, with HRQL and self-efficacy assessed using validated questionnaire, approximately 2 weeks prior to and 2 weeks after challenge. Where possible, anaphylaxis was treated with self-injected adrenaline (epinephrine). MAIN OUTCOME MEASURES: Change in HRQL and self-efficacy. RESULTS: 56 participants had reactions at food challenge, of whom 16 (29%) had anaphylaxis. Overall, there was an improvement in HRQL (mean 2.6 points (95% CI 0.3 to 4.8); p=0.030) and self-efficacy (mean 4.1 points (95% CI 2.4 to 5.9); p<0.0001), independent of whether anaphylaxis occurred. Parents also reported improved HRQL (mean 10.3 points (95% CI 5.9 to 14.7); p<0.0001). We found evidence of discordance between the improvement in HRQL and self-efficacy as reported by young people and that perceived by parents in their child. CONCLUSIONS: Anaphylaxis at food challenge, followed by self-administration of injected adrenaline, was associated with an increase in HRQL and self-efficacy in young people with peanut allergy. We found no evidence that the occurrence of anaphylaxis had a detrimental effect. Young people should be encouraged to self-administer adrenaline using their autoinjector device to treat anaphylaxis at in-hospital challenge. TRIAL REGISTRATION NUMBER: NCT02149719.

Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire.

BACKGROUND: Patient-reported outcome (PRO) instruments provide robust and effective means of evaluating patients' treatment experience; however, none adequately cover experience using self-injection devices with enhanced features, such as an electromechanical autoinjector (e-Device). The aim of this study was to develop a PRO instrument that accurately assesses patient experience of using an e-Device and to evaluate its psychometric properties. METHODS: A mixed-methods approach was taken; two parallel, targeted literature reviews were conducted to identify relevant concepts and existing self-injection PRO instruments that could be adapted. Patient feedback obtained from two focus groups was used to inform initial instrument development. The pilot instrument was then administered in a multicenter, open-label, phase 3 clinical study in which patients self-injected certolizumab pegol using an e-Device, to gather evidence of its psychometric qualities. Exit interviews were conducted with a sub-sample of patients enrolled in the study to confirm the appropriateness and clarity of the items included and cognitively debrief the instrument. Confirmatory factor analysis (CFA) was conducted on all items, and each domain's internal consistency was measured using Cronbach's ɑ. RESULTS: The literature searches identified several e-Device-specific concepts related to device features, device function, side effects/reactions/pain, confidence, and interference/convenience in daily life. Seven existing PRO instruments were identified. The Self-Injection Assessment Questionnaire (SIAQ), containing pre- and post-injection questionnaire modules, was selected as most suitable and adapted using feedback from 19 patients in the two focus groups to form the pilot Assessment of Self-Injection (ASI) questionnaire. CFA resulted in some changes to the grouping of items in the post-injection module domains following psychometric evaluation of the ASI. Internal consistency was satisfactory for all pre- and post-injection domains (ɑ > 0.8). Cognitive debriefing results from 12 patient exit interviews confirmed the ASI's appropriateness and clarity. CONCLUSIONS: The ASI was developed iteratively with patient input and was evaluated in its intended clinical context of use. Psychometric analyses indicated promising cross-sectional results; the ASI was well understood and considered relevant by patients self-injecting using the e-Device, suggesting that it could be used in real-world settings to aid with clinical decision making. TRIAL REGISTRATION: NCT03357471.

Prefilled pen versus prefilled syringe: a pilot study evaluating two different methods of methotrexate subcutaneous injection in patients with JIA.

BACKGROUND: Methotrexate is the most commonly used disease-modifying antirheumatic drug recommended in the treatment of juvenile idiopathic arthritis. It can be administered orally or subcutaneously, the latter method is associated with fewer side effects and higher drug bioavailability. Nevertheless, the pain associated with injection is a considerable drawback of this treatment option in the pediatric population. Currently, there are two single-use subcutaneous injection devices available: the prefilled syringe and the prefilled pen. This prospective, two-sequence crossover study aimed to compare ease of use, frequency of therapy side effects, injection-site pain and parent/patient preference of those methotrexate parenteral delivery systems. METHODS: Twenty-three patients with juvenile idiopathic arthritis, already treated with subcutaneous methotrexate in the form of prefilled syringe in the period October 2018 - April 2019 completed a questionnaire evaluating their experience with this device. Subsequently, children received a one-month supply of pen autoinjector and completed the same questionnaire, regarding their experience with the new methotrexate delivery system. If the patient was not performing the injections himself the questionnaires were completed by the caregiver administrating MTX. The results obtained in both questionnaires were compared using the Wilcoxon matched-pairs signed-rank test. RESULTS: 82,6% patients and their caregivers voted for the prefilled pen as their preferred method of subcutaneous methotrexate administration. Moreover, the injection with the prefilled pen was reported as less painful in comparison to the prefilled syringe (p < 0.01). Side effects of methotrexate were less pronounced after the prefilled pen treatment, this difference was most prominent regarding gastrointestinal adverse events associated with the injection (p < 0.01). CONCLUSION: Administration of methotrexate using the pen device is a promising way of subcutaneous methotrexate delivery in children with juvenile idiopathic arthritis, as the injection is less painful and associated with fewer side effects.

Inhaler devices in asthma and COPD patients - a prospective cross-sectional study on inhaler preferences and error rates.

BACKGROUND: Inhalation therapy is the backbone of asthma and COPD control. However, inhaler adherence and device mishandling continue to be a problem in real life. Some studies have shown that using a patient-preferred inhaler may reduce device handling errors and improve adherence to prescribed chronic inhaler drug therapy. The aim of this study was to compare the preferences for commonly used inhaler devices in Germany in patients with chronic obstructive respiratory disease. We also pursued the question which properties of an inhaler device are particularly important to the user and what effects age, gender and type of disease (asthma or COPD) may have on device preference and handling errors. METHODS: Prospective, open-label cross-sectional study in which 105 patients with asthma (58%) or COPD (42%) participated. Validated checklists were used to objectively assess inhaler technique and errors with 10 different placebo devices. For each device, patients were asked to test the handling, to assess the device properties and to name the device that they would most or least prefer. RESULTS: Across the 10 placebo inhaler devices tested, patients needed an average of 1.22 attempts to error-free use. The device with the lowest mean number of attempts was the Turbohaler® (1.02), followed by the Nexthaler® (1.04), the Diskus® (1.07) and the Spiromax® (1.10). Patients over 60 years vs. younger age (p = 0.002) and COPD vs. asthma patients (p = 0.016) required more attempts to ensure correct use. 41% of the study participants chose one of the devices they already used as the most preferred inhaler. Overall, 20% opted for the Spiromax®, 15% for the Nexthaler® and 14% for the Turbohaler® or a pMDI. The least preferred device was the Elpenhaler® (0%). From a selection of 7 predefined inhaler attributes, patients stated easy handling as the most important for them. This was followed by short inhalation time and low inhalation resistance. CONCLUSIONS: Patient preference may vary between inhaler devices. The lowest number of attempts to error-free use was reported for the Turbohaler® and the Nexthaler®. The Spiromax® and the Nexthaler® achieved the best overall ratings and were the devices most preferred by patients.

Self-injectable epinephrine: doctors' attitude and patients' adherence in real-life.

PURPOSE OF REVIEW: Epinephrine is the only life-saving treatment of anaphylaxis. Prescription and administration rates of self-injectable epinephrine are generally low. It is unclear whether this is because of availability, low prescription rates, fear of using epinephrine, or a combination of these issues. RECENT FINDINGS: This review focuses on what self-injectable epinephrine devices (SIED), such as auto-injectors and prefilled syringes, are preferred by patients and healthcare professionals (HCP). Our findings suggest that a device's ease to use, proper and frequent training on its operability, and availability have an impact on preferences and adherence to treatment with SIEDs. After prescribing a patient with a SIED, clinicians should emphasize its use in anaphylaxis, educate patients/caregivers to identify anaphylaxis and on how to use the SIED, and encourage constant practicing with training devices. SUMMARY: Epinephrine is the sole recommended anaphylaxis treatment and SIEDs are of critical usefulness in the community setting. Further studying of these devices is needed to optimize education for HCPs and patients and their accessibility to SIEDs.

A pen device for injection of recombinant human growth hormone: a European usability engineering study.

OBJECTIVE: The Aluetta™ reusable pen device and instructions for use (IFU) for growth hormone (r-hGH; Saizen®, Merck KGaA, Darmstadt, Germany) administration were tested for Human-Factors Usability, to ensure it could be used safely and effectively by the intended users in the intended use environment. RESEARCH DESIGN AND METHODS: Usability testing was conducted under simulated conditions in three groups of participants: pediatric or adult patients with growth hormone deficiency (GHD), participants without GHD, and healthcare professionals (HCPs). The testing comprised a 45-minute training session, a 2-hour testing session, and a participant-feedback session. RESULTS: Twenty-six participants completed the training session and performed all critical tasks related to the pen use across three scenarios. The most difficult tasks were related to the preparation, checking, and maintenance of the device; only 8% of use errors occurred during tasks related to the injection process. Eighty-five percent considered the pen safe and effective to use without further modifications and the training to be clear and effective. CONCLUSIONS: The pen device and associated materials benefited from Human Factors Engineering throughout the development process. These evaluations show that patients and HCPs could safely and effectively use the pen device, and the IFU and training were clear and effective.

Biological agents for severe asthma: the evolution of the at-home self-injection approach.

PURPOSE OF REVIEW: New biological agents, in addition to the well-established omalizumab, have been nowadays introduced into clinical practice for severe asthma. This suggested the possibility of an at-home self-administration, as currently happening for other biological agents for immune-mediated diseases. RECENT FINDINGS: In the very recent years, there were structured clinical trials investigating the self at home administrations of biologicals for severe asthma, showing with different principles, a possible advantage and convenience for the patient, and a socioeconomic saving. SUMMARY: The literature analysis currently shows that the at-home self-administration of biologicals for severe asthma is a promising approach to improve the treatment of such disease.

Autoinjector device for rapid administration of drugs and antidotes in emergency situations and in mass casualty management.

There are several situations such as medical emergencies and incidents involving mass casualties where drugs and antidotes have to be administered immediately along with other first aid at the site of the event. Self-administration by the affected person or by a companion is required as a life-saving measure. Autoinjector devices (AIDs) are useful for the rapid administration of drugs and antidotes and they can also be used by those who have not been medically trained. This makes them very convenient for emergency and mass casualty management. An AID has a drug cartridge with an embedded needle for subcutaneous or intramuscular injection, which is usually painless. The drugs are delivered slowly by the AID across a large area in the muscle, which increases the absorption and the drug effects are equal to that of intravenous administration. A variety of AIDs are available, such as atropine and pralidoxime for nerve agent poisoning, epinephrine for anaphylactic shock and allergy, diazepam for seizures, sumatriptan for migraine, amikacin for antibacterial treatment, buprenorphine for pain relief and monoclonal antibodies for a variety of diseases. This review describes the published peer-reviewed literature identified by online searches of journal databases.

Estimation of available epinephrine dose in expired and discolored autoinjectors via quantitative smartphone imaging.

Epinephrine autoinjectors (EAIs) are important first aid medications for treating anaphylaxis. A 10-fold price increase over the past 12 years and evidence that expired EAIs may still contain significant doses of available epinephrine have motivated interest in the efficacy of expired EAIs as treatments of last resort. Degradation of expired EAIs, which can be caused by improper storage conditions, results in various degrees of discoloration of the epinephrine solution. Previous studies have determined that significant epinephrine remains available in expired EAIs, but these have only considered EAIs that show no discoloration. Here, we investigate the potential for colorimetric estimation of available epinephrine dose based on the degree of discoloration in expired EAIs. The correlation of available epinephrine dose and time since expiration date was poor (r = - 0.37), as determined by an industry standard UHPLC protocol. Visible absorbance of the samples integrated across the range 430-475 nm correlated well with available epinephrine dose (r = - 0.71). This wavelength corresponds to the blue channel of a typical smartphone camera Bayer filter. Smartphone camera images of the EAI solutions in various illumination conditions were analyzed to assign color indices representing the degree of discoloration. Color index of the samples showed similar correlation (|r| > 0.7) with available epinephrine dose as that of visible spectrophotometry. Smartphone imaging colorimetry is proposed as a potential point-of-use epinephrine dose estimator for expired and degraded EAIs. Graphical abstract.

Usability of mepolizumab single-use prefilled autoinjector for patient self-administration.

Objective: To evaluate usability of mepolizumab as a liquid drug product self-administered via a single-use prefilled autoinjector (AI) by patients with severe eosinophilic asthma (SEA), or their caregivers, in-clinic and at home.Methods: This open-label, single-arm, Phase IIIa study (NCT03099096; GSK ID: 204959) included patients aged ≥12 years with SEA who were either receiving mepolizumab (100 mg subcutaneously [SC]) every 4 weeks (Q4W) for ≥12 weeks before screening or not receiving mepolizumab but met criteria indicative of SEA. Patients/caregivers self-administered mepolizumab (100 mg SC) via an AI Q4W for 12 weeks. The first (Week 0) and third (Week 8) doses were observed in-clinic; the second dose (Week 4) was administered unobserved at home. Primary and secondary endpoints were the proportion of patients who successfully self-administered their third and second doses, respectively (determined by investigator/site staff). Patient experience, mepolizumab trough concentrations, blood eosinophil count (BEC), and safety were also assessed.Results: Of 159 patients/caregivers who self-administered ≥1 dose of mepolizumab, 157 completed the study. Nearly all patients successfully self-administered their third mepolizumab dose in-clinic and second dose at home (≥98% and ≥96%, respectively); this was further confirmed by mepolizumab trough concentrations/BEC. At study end, ≥88% of patients were "very" or "extremely" confident about using the AI correctly. Incidence of on-treatment drug-related adverse events (AEs) was low (3%); no fatal AEs occurred.Conclusions: Patients/caregivers successfully self-administered mepolizumab via the AI both in-clinic and at home; no new safety concerns were identified.

Usability of mepolizumab single-use prefilled syringe for patient self-administration.

Objective: A liquid mepolizumab formulation in a single-use prefilled syringe (PFS) is under development. We evaluated the usability of mepolizumab self-injected via PFS by patients with severe eosinophilic asthma (SEA), or their caregivers, in clinic and at home.Methods: This open-label, single-arm, Phase IIIa study included patients with SEA, aged ≥12 years, and receiving mepolizumab (100 mg subcutaneously) every 4 weeks for ≥12 weeks prior to screening. Patients with SEA not receiving mepolizumab at screening who met additional criteria were also included. Patients/caregivers self-administered mepolizumab (100 mg subcutaneously) via PFS every 4 weeks for 12 weeks. The first (Week 0) and third (Week 8) dose were observed in clinic; the second dose (Week 4) was unobserved at home. Primary and secondary endpoints were the proportion of patients who successfully self-administered their third and second doses, respectively. Injection success was determined by investigator/site staff. Patient experience, mepolizumab trough concentrations, blood eosinophil counts, and safety were also assessed.Results: Of the 56 patients/caregivers who self-administered ≥1 dose of mepolizumab, 55 completed the study. All patients were reported to have successfully self-administered their third mepolizumab dose in clinic (N = 55, 100%); this was further evidenced by trough concentrations/blood eosinophil counts. Most patients/caregivers found the PFS easy and convenient to use with 75% (n = 42) expressing little/no anxiety about using the device at home. Incidence of on-treatment drug-related adverse events was low (4%); none were fatal.Conclusions: Patients/caregivers successfully self-administered mepolizumab via the PFS both in clinic and at home, with no new safety concerns identified.

Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study.

Objectives: Guselkumab, an interleukin-23 antagonist, is approved for self-administration with the UltraSafe Plus™ syringe to treat moderate-to-severe plaque-type psoriasis. We evaluated the efficacy, safety, pharmacokinetics, and acceptability of guselkumab administered using a novel patient-controlled injector (One-Press) in psoriasis patients.Materials and methods: This Phase 3, multicentre, double-blind, placebo-controlled study (ORION, Clinicaltrials.gov identifier-NCT02905331) randomized adults with moderate-to-severe psoriasis (4:1) to guselkumab 100 mg at Weeks 0/4/12/20/28 or placebo at Weeks 0/4/12 with crossover to guselkumab 100 mg at Weeks 16/20/28. Week 16 co-primary endpoints were the proportions of patients achieving Investigator Global Assessment (IGA) cleared/minimal (IGA 0/1) and Psoriasis Area and Severity Index 90% improvement (PASI90) responses. One-Press usability/acceptability was evaluated using the Self-Injection Assessment Questionnaire (SIAQ) and Patient-Controlled Injection Device Questionnaire. Final assessments occurred at Week 40.Results: At Week 16, significantly higher proportions of guselkumab-treated (N = 62) than placebo-treated (N = 16) patients achieved IGA 0/1 (80.6% vs. 0.0%, p < .001) and PASI90 (75.8% vs. 0.0%, p < .001) responses. Adverse events were comparable between treatments. SIAQ results demonstrated 99% (68/69) of patients were satisfied/very satisfied with One-Press at Week 28.Conclusions: Guselkumab administered using the One-Press patient-controlled injector was efficacious and well-tolerated in moderate-to-severe psoriasis patients, consistent with previously reported Phase-3 studies of guselkumab administered using UltraSafe Plus. One-Press was highly acceptable to patients.

The SYDNEY Device Study: A Multicenter, Randomized, Open-label Usability Study of a 2-mL Alirocumab Autoinjector Device.

PURPOSE: The proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab has produced significant reductions in LDL-C at a dose of 300 mg q4w administered as 2 separate 150-mg injections via a 1-mL autoinjector (AI). A recently developed 2-mL device (SYDNEY) permits the administration of a single 300mg dose of alirocumab. METHODS: We assessed the usability and product technical complaints (PTCs) reported by patients using the 2-mL SYDNEY device in unsupervised settings, adverse events, and effects on LDL-C, in a multicenter, randomized, open-label, 16-week study conducted in the United States. For their first dose, 69 patients with hypercholesterolemia despite receiving statin with or without other lipid-lowering therapy randomly received supervised, self-administered alirocumab 300 mg via 1 × 300 mg injection with the SYDNEY device (n = 35) or 2 × 150-mg injections with the currently approved AI (n = 34). All continuing patients subsequently received unsupervised, self-administered alirocumab 300 mg q4w using the SYDNEY device at weeks 4, 8, and 12. The primary end point was the proportion of SYDNEY device-associated PTCs related to the use of the unsupervised injections. FINDINGS: Baseline characteristics between the study arms varied only in a higher percentage of males being randomized to the study arm using the SYDNEY device (74.3%) compared with the AI arm (44.1%). A single PTC was reported during the unsupervised injections (0.5%; 1 of 196 injections; 95% CI, 0.0%-3.2%). This event was classified as patient related as opposed to device related. No PTCs occurred during supervised injections. Mean LDL-C reductions from baseline at week 4 were 66.2% with SYDNEY and 51.2% with the AI; after adjustment for sex differences between groups, mean LDL-C reductions were 63.5% and 53.9%, respectively. LDL-C reductions persisted for 16 weeks. The most common adverse event was upper respiratory tract infection (3 with SYDNEY and 0 with the AI during weeks 0-4). IMPLICATIONS: The SYDNEY device allowed for a single 2-mL injection of alirocumab 300 mg, providing substantial LDL-C reductions with no new product technical issues or no new safety concerns compared with the currently marketed 1-mL AI device. In conclusion, the 2-mL SYDNEY device provides patients with the possibility of injecting the 300-mg alirocumab dose as a single injection. ClinicalTrials.gov identifier: NCT03415178.