Real-world evidence has demonstrated that onabotulinumtoxinA therapy leads to a decrease in health care resource utilization (HRU) and provides long-term benefits in patients with chronic migraine. This is according to research published in The Journal of Headache and Pain.
In the current study, researchers analyzed health care resource utilization in a subset of the 2-year, prospective, noninterventional, observational, open-label REPOSE study cohort (ClinicalTrials.gov identifier NCT01686581), with particular emphasis on the German patient population. REPOSE was conducted from 2012 to 2016 at 78 centers in 7 countries and included adults prescribed onabotulinumtoxinA for the treatment of chronic migraine.
Study outcomes included treatment effectiveness measured by the change from baseline in patient estimates of frequency of headache days and results of the Migraine Specific Quality of Life Questionnaire (MSQ) and the EuroQol 5-Dimension Questionnaire (EQ-5D).
REPOSE enrolled 641 patients, of whom 633 received 1 or more onabotulinumtoxinA treatments and were included in the Safety Analysis Set. Of these patients, 128 completed 24 months and were included in the Per-Protocol Set. Of the initial 633 patients, 22.7% discontinued treatment.
Approximately 60% of patients included in the Safety Analysis Set were treated at German study centers; 70% of these patients completed the health economics questionnaire. These patients had baseline characteristics similar to those of the overall study population (mean age, 46.3±11.8 years; 84.4% women).
REPOSE patients received a mean of 5.5±3.0 onabotulinumtoxinA treatment sessions for chronic migraines, with a mean dose of 155.1±21.4 U and 31.4±4.3 injection sites across a mean of 6.9±0.6 muscle areas per session. Median time from baseline to treatment administration visit 8 was 21.7 months.
In the overall population, headache day frequency was significantly reduced from baseline through administration visit 8 (mean 20.6±5.4 days to 7.4±6.6 days) and from 18.9±4.5 days to 6.0±5.8 days in the German population. In both populations, total MSQ scores significantly increased at all post-baseline visits — indicating an improvement in patient reported quality of life. EQ-5D results also showed a similar significant improvement. The majority of patients both overall and at German study centers indicated satisfaction with treatment and rated treatment tolerability as good or very good across the 2-year observation period.
In both the overall and German study populations, health care resource utilization decreased significantly from baseline with onabotulinumtoxinA treatment for chronic migraine. There was a significant reduction in overall headache-related hospital admissions, from 6.0% to 1.7% at administration visit 2, with a continued decrease to 1.0% at visit 8. Results in the German population were similar, with a decrease in visits from 4.2% to 0.8% at baseline and visit 8, respectively.
Trends in other countries were consistent with overall findings, although no statistical analyses were performed.
The proportion of patients who visited any health care provider in the 3-month period prior to baseline was 45.8% and 35.8% in the overall and German populations, respectively. By administration visit 8, these proportions decreased significantly: 12.5% and 8.1% in the overall and German populations. There was also a statistically significant decrease in the number of primary care and outpatient consultations in both groups.
The German Analysis set also included 264 patients with available health economics data. Results of a health economics questionnaire indicated that health services were used most frequently in the 6 months prior to baseline (visit to a medical specialist, 61.7%, and visit to a family doctor, 41.7%). Medication for acute headache treatment was taken by 71.2% of patients.
At each study timepoint, the proportion of patients utilizing health services since their previous visit was less than the proportion of patients with respective service utilization during the 6-month pre-baseline period. At administration visit 8, only 13.5% of patients reported a visit to a family doctor — significantly fewer than the pre-baseline number of 41.7%.
The number of patients who reported the use of remedies, including massage, physiotherapy, and manual therapy, also decreased during the 2-year observation period (32.6% to 16.7% from baseline to visit 8).
Fewer patients also reported inpatient treatment or acute medication use at administration visit 8 vs baseline, but differences were not statistically significant. Just over 6% of patients reported inpatient treatment at an acute care hospital within 6 months of their baseline visit, which decreased to 2.6% at visit 2 and 0% at visit 8. There was also a decrease in the percentage of patients who reported taking acute headache treatment medication (71.2% vs 58.3% at baseline and visit 8).
Reports of incapacity for work, absenteeism, and impaired performance due to headache also significantly improved with onabotulinumtoxinA treatment, as did absences from school or work. Patients reporting disability also decreased, although the change was not significant.
Adverse drug reactions were reported by 18.3% of patients, and these reactions were primarily mild or moderate (7.1% and 7.4%, respectively). In more than 2% of patients, these reactions included eyelid ptosis, neck pain, and musculoskeletal stiffness.
Study limitations include the possibility that patients may have been taking concomitant preventive medications; possible discontinuation of onabotulinumtoxinA treatment due to lack of efficacy, leading to an enriched patient population and potential confounding of results; and the small number of patients reporting health care resource utilization at later visits, possibly reflecting patients who responded to treatment.
“[Chronic migraine] treatment with onabotulinumtoxinA was associated with a significant reduction in monthly headache days and decreased [healthcare resource utilization] in German patients,” the researchers concluded. “These data support the long-term benefits associated with the use of onabotulinumtoxinA…in German clinical practice.”
Disclosure: This clinical trial was supported by Allergan. Please see the original reference for a full list of authors’ disclosures.
Kollewe K, Gaul C, Gendolla A, Sommer K. Real-life use of onabotulinumtoxinA reduces healthcare resource utilization in individuals with chronic migraine: the REPOSE study. J Headache Pain. 2021;22(1):50. doi:10.1186/s10194-021-01260-4