Abstracts

Rationale:
Treatment satisfaction is associated with medication adherence. ARTEMIS-2/P261-402 (NCT01529034) is a Phase III, open‐label extension trial in patients (≥12 years) with seizure clusters (SCs) who completed randomized controlled trial ARTEMIS‐1/P261-401 (NCT01390220). ARTEMIS-1 has shown clinical efficacy of midazolam nasal spray (MDZ-NS) (Detyniecki et al. Epilepsia 2019;60:1797-1808). This ARTEMIS-2 analysis assessed treatment satisfaction, anxiety level, and confidence about traveling with MDZ-NS after repeated intermittent use in the outpatient setting.
Method:
Caregivers administered MDZ‐NS 5 mg when patients experienced a SC; a second dose could have been given if seizures did not end within 10 min or recurred within 10 min–6 h. Patient satisfaction with MDZ-NS was assessed with the Treatment Satisfaction Questionnaire for Medication (TSQM). Patient and caregiver perceptions of how having access to MDZ-NS might impact their lives was assessed with the Intranasal Therapy Impact Questionnaire (ITIQ). The questionnaires were completed by the patient and caregiver at each visit. At Visits (V)1 (Screening) and 2, patients received one kit (containing two 5 mg MDZ-NS doses, enough to treat one episode); at later visits, they received two kits. Patients and caregivers returned to study center following one treated SC after V1 and V2, and following two treated SCs thereafter. At least 3 days (72 h) was required between treatments. TSQM and ITIQ analyses were exploratory (descriptive statistics) and performed on the Efficacy Evaluable Set (patients who received ≥1 MDZ-NS dose and had a post-treatment efficacy assessment).
Results:
Of 175 enrolled patients, 161 (92.0%) were in the Efficacy Evaluable Set. At Last Visit, at least 135 patients had values for each TSQM scale (and Baseline), and 145 patients and 160 caregivers completed the ITIQ. All TSQM scales showed improvement from Baseline at Last Visit (Fig. 1). Mean change from Baseline showed a tendency to improve at V1­ to V10 for all TSQM scales except side-effects, and improvement generally increased over repeated MDZ-NS use for all scales. Mean change in anxiety level since receiving MDZ-NS (ITIQ; ranging from −7 to 7; 0=no change; 7=best) improved from 2.5 (standard deviation 2.5) (V1) to 3.5 (2.7) (Last Visit) in patients and from 2.6 (2.5) to 3.6 (2.7) in caregivers, and generally improved over repeated MDZ-NS use in patients and caregivers. The proportions of patients and caregivers who answered ‘strongly agree’ or ‘agree’ for confidence about traveling with an intranasal spray remained at 79% or higher and rose over repeated MDZ-NS use from V1 to V10 (Fig. 2).
Conclusion:
Patients perceived MDZ-NS to be a favorable therapy, as shown by an improvement from Baseline on perceived effectiveness, side-effects, convenience, and global satisfaction. This is supported by improvement in anxiety level and consistently high confidence about traveling with MDZ-NS in patients and caregivers over repeated intermittent use.
Funding:
:UCB Pharma-sponsored