Dataset Information

A Qualitative Study to Explore Patient Perspectives of Prophylactic Treatment with OnabotulinumtoxinA for Chronic Migraine.

ABSTRACT:

Introduction

OnabotulinumtoxinA (OBT-A) is one of the most studied prophylactic treatments for chronic migraine. Large clinical trials, and now real-world studies, continue to provide evidence to support the use of OBT-A as an effective treatment to manage chronic migraine. The objective of this study was to explore patient experience and perception of prophylactic treatment with OBT-A for chronic migraine.

Methods

Data were collected using semi-structured interviews using open-ended questions to uncover rich descriptive data on patient experiences. Interviews were transcribed and analysed using NVivo data analysis software to code and identify themes across the dataset. Three patient groups were included in the analysis: (1) patients who were receiving continued OBT-A treatment; (2) patients who discontinued OBT-A treatment; (3) patients who were recommended for OBT-A treatment but did not proceed.

Results

For patients who received at least one OBT-A treatment, four main themes emerged, which described patients' expectations, experiences, and feelings towards their treatment decisions. Two main themes emerged that were common to patients, who had discontinued their treatment and those, who were recommended for OBT-A treatment but did not proceed, which were identified as potential barriers to initiate or continue prophylactic treatment with OBT-A.

Conclusion

Understanding patients' perspective is an important part of clinical practice and may impact on decision-making. Qualitative data can provide a more holistic view of patient care and treatment insights that may not be evaluated during a clinical trial. This study revealed potential barriers to treatment that can inform future policy and practice.

SUBMITTER: Wilderman I

PROVIDER: S-EPMC8586057 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionOnabotulinumtoxinA is approved in the USA for the prevention of headache in adults with chronic migraine, a debilitating neurologic disease characterized by headaches occurring on ≥ 15 days per month for > 3 months and including migraine features on ≥ 8 days per month.ObjectiveThe COMPEL Study (NCT01516892), a 108-week, multi-center, open-label study, evaluated the long-term efficacy and safety of onabotulinumtoxinA in adults with chronic migraine. The objective of this subanalysis was to examine the safety and tolerability of onabotulinumtoxinA after each of nine treatment cycles.MethodsOnabotulinumtoxinA 155 U was administered every 12 weeks. Safety and tolerability, overall and by treatment cycle, were assessed. Treatment-emergent adverse events reported between successive treatments were attributed to the preceding treatment. The safety population received one or more doses of onabotulinumtoxinA. The primary efficacy outcome was the reduction in headache days at week 108 compared with baseline.ResultsOf 716 patients enrolled, 373 patients (52.1%) completed the study and 343 (47.9%) withdrew; 481 patients (67.2%) received 60 weeks of treatment and 402 (56.1%) received 108 weeks of treatment. In total, 436 (60.9%) patients reported treatment-emergent adverse events; most were mild/moderate in severity. Thirty-two patients (4.5%) discontinued the study after experiencing treatment-emergent adverse events. The incidence of treatment-emergent adverse events typically decreased with repeated onabotulinumtoxinA treatment: first cycle, 24.2%; fourth cycle, 18.4%; ninth cycle, 12.2%. Neck pain (2.7%), eyelid ptosis (1.8%), musculoskeletal stiffness (1.4%), injection-site pain (1.3%), and headache (1.3%) were the most common treatment-emergent adverse events after the first cycle. Seventy-five patients (10.5%) reported serious treatment-emergent adverse events, 13 (1.8%) withdrew. Treatment-related adverse events were reported by 131 patients (18.3%), one was considered serious. OnabotulinumtoxinA significantly reduced headache day frequency by 10.7 (6.4) days per 28-day period (p < 0.0001) at week 108.ConclusionsOnabotulinumtoxinA treatment was well tolerated over 108 weeks; no new safety signals were identified. The overall incidence of treatment-emergent adverse events and the most common individual events decreased with repeated onabotulinumtoxinA administration.Clinical trial registrationClinicalTrials.gov; NCT01516892.