Neurological
Onabotulinum toxin A therapy leads to a lower use of health resources in chronic migraines
Real-world evidence has shown that onabotulinum toxin A therapy results in a reduction in health care resource use (HRU) and provides long-term benefits in patients with chronic migraines. This comes from a study published in the Journal of Headache and Pain.
In the current study, the researchers analyzed resource use in healthcare in a subset of the 2-year, prospective, non-interventional, observational, open REPOSE study cohort (ClinicalTrials.gov identifier NCT01686581) with a special focus on the German patient population. REPOSE was conducted in 78 centers in 7 countries from 2012 to 2016 and included adults prescribed onabotulinum toxin A for the treatment of chronic migraines.
Study results included treatment effectiveness, as measured by the change from baseline in patient estimates of the frequency of headache days and the results of the Migraine-Specific Quality of Life Questionnaire (MSQ) and the EuroQol 5-Dimension Questionnaire (EQ-5D).
Continue reading
REPOSE enrolled 641 patients, 633 of whom received one or more onabotulinum toxin A treatments and were included in the safety analysis kit. Of these patients, 128 completed 24 months and were included in the Per-Protocol Set. Of the initial 633 patients, 22.7% discontinued treatment.
About 60% of the patients included in the Safety Analysis Set were treated in German study centers; 70% of these patients completed the health economics questionnaire. At baseline, these patients had similar characteristics to the total study population (mean age 46.3 ± 11.8 years; 84.4% women).
REPOSE patients received an average of 5.5 ± 3.0 onabotulinum toxin A treatment sessions for chronic migraine with an average dose of 155.1 ± 21.4 U and 31.4 ± 4.3 injection sites over an average of 6.9 ± 0.6 muscle areas per session. The median time from baseline to treatment appointment 8 was 21.7 months.
In the total population the frequency of the headache days was up from the baseline value up to the administration visit 8 (mean value 20.6 ± 5.4 days to 7.4 ± 6.6 days) and in the German population from 18.9 ± 4.5 days Significantly reduced 6.0 ± 5.8 days. In both populations, total MSQs increased significantly in all post-baseline exams, indicating an improvement in patient-reported quality of life. The EQ-5D results also showed a similarly significant improvement. The majority of patients, both overall and in German study centers, reported satisfaction with the treatment and the tolerability of the treatment as good or very good over the 2-year observation period.
In the total population as well as in the German study population, the use of health resources during the treatment of chronic migraines with OnabotulinumtoxinA decreased significantly compared to the initial value. Overall, there was a significant reduction in headache-related hospital admissions from 6.0% to 1.7% on visit 2, with a continued decrease to 1.0% on visit 8. The results in the German population were similar, with one decrease of visits from 4.2% to 0.8% at the beginning of the study or visit 8.
Trends in other countries were consistent with the overall results, although statistical analysis was not carried out.
The proportion of patients who visited a health care provider in the three months prior to the start of the study was 45.8% and 35.8% in the total population and in the German population. By the administrative visit 8, these proportions decreased significantly: 12.5% and 8.1% in the total population and in the German population. The number of general practitioner and outpatient consultations also decreased statistically significantly in both groups.
The German analysis set also included 264 patients with available health economic data. The results of a health economic questionnaire showed that health services were most frequently used in the 6 months prior to the start of the study (specialist doctor 61.7% and family doctor 41.7%). Drugs used to treat acute headache were taken by 71.2% of the patients.
At every point in the study, the proportion of patients who had made use of health services since their previous visit was lower than the proportion of patients who made use of corresponding services during the 6-month period prior to the start of the study. With administration 8, only 13.5% of the patients reported a visit to a family doctor – significantly less than the value before the start of the study 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 the use of acute medication at the administration visit 8 compared to baseline, but the differences were not statistically significant. Slightly more than 6% of the patients reported inpatient treatment in an acute hospital within 6 months of their first visit, which fell to 2.6% on visit 2 and 0% on visit 8 Drugs for the treatment of acute headaches (71.2% vs. 58.3% at the beginning of the study and visit 8).
Reports of incapacity for work, absenteeism and performance restrictions due to headaches also improved significantly under treatment with onabotulinum toxin A, as did absenteeism from school or work. The number of patients reporting a disability also decreased, although the change was not significant.
Adverse drug reactions were reported by 18.3% of the patients and these reactions were mainly 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 restrictions include the possibility that patients have been taking preventive medications at the same time; possible discontinuation of treatment with OnabotulinumtoxinA due to lack of efficacy, which leads to an enrichment of the patient population and potential falsification of the results; and the small number of patients who reported health resource utilization on subsequent visits, possibly due to patients who responded to treatment.
“[Chronic migraine] Treatment with onabotulinum toxin A was associated with a significant reduction in the number of monthly headache days and decreased [healthcare resource utilization] in German patients, ”concluded the researchers. “These data demonstrate the long-term benefit associated with the use of onabotulinum toxin A in German clinical practice.”
Disclosure: This clinical study was sponsored by Allergan. For a full list of the author’s disclosures, see the original reference.
reference
Kollewe K, Gaul C, Gendolla A, Sommer K. The practical application of onabotulinum toxinA reduces the use of health resources in people with chronic migraines: the REPOSE study. J headache pain. 2021; 22 (1): 50. doi: 10.1186 / s10194-021-01260-4
This article originally appeared on Clinical Pain Advisor