Evidence map›Paper›PMID 34078259›Full record

Observational studyThe journal of headache and pain2021

Real-life use of onabotulinumtoxinA reduces healthcare resource utilization in individuals with chronic migraine: the REPOSE study.

Katja Kollewe, Charly Gaul, Astrid Gendolla, Katherine Sommer

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in The journal of headache and pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01686581 (A 24-month, Prospective, Non-interventional Study to Describe the Long Term, Real-Life Use of BOTOX® for the Symptomatic Treatment of Adults With Chronic Migraine, Measuring Healthcare Resource Utilization, and Patient Reported Outcomes Observed in Practice), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01686581 completednot on this map

A 24-month, Prospective, Non-interventional Study to Describe the Long Term, Real-Life Use of BOTOX® for the Symptomatic Treatment of Adults With Chronic Migraine, Measuring Healthcare Resource Utilization, and Patient Reported Outcomes Observed in Practice

TypeobservationalSponsorAllerganRan2012 to 2016Enrolled641ConditionsMigraine DisordersArmsbotulinum toxin Type A
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Observational
  4. Review
  5. Observational
  6. Observational
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 2 countries.

Katja KolleweMedical School Hannover, Carl-Neuberg-Straße 1, 30625, Hannover, Germany. Kollewe.Katja@mh-hannover.de.
Charly GaulMigraine and Headache Clinic, Königstein, Germany.
Astrid GendollaPraxis fur Neurologie, Essen, Germany.
Katherine SommerAllergan, An AbbVie Company, Marlow, Buckinghamshire, UK.
Allergan (United Kingdom) · GBMedizinische Hochschule Hannover · DEMigräne Klinik Königstein · DETierärztliche Praxis für Neurologie · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic migraine (CM) is associated with substantial economic burden. Real-world data suggests that onabotulinumtoxinA treatment for CM reduces healthcare resource utilisation (HRU) and related costs.

methodsREPOSE was a 2-year prospective, multicentre, non-interventional, observational study to describe the real-world use of onabotulinumtoxinA in adult patients with CM. This analysis examined the impact of onabotulinumtoxinA on HRU. Patients received onabotulinumtoxinA treatment approximately every 12 weeks according to their physicians' discretion, guided by the summary of product characteristics (SPC) and PREEMPT injection paradigm. HRU outcome measures were collected at baseline and all administration visits and included headache-related hospitalizations and healthcare professional (HCP) visits. Health economic data, including family doctor and specialist visits, inpatient treatment for headache, acupuncture, technical diagnostics, use of nonpharmacologic remedies, and work productivity were also collected for patients enrolled at German study centres.

resultsOverall, 641 patients were enrolled at 78 study centres across 7 countries (Germany, UK, Italy, Spain, Norway, Sweden, and Russia), 633 received ≥1 onabotulinumtoxinA dose, and 128 completed the 2-year study. Patients were, on average, aged 45 years, 85% were female, and 60% (n = 377) were from Germany. At the end of the 2-year observation period, significantly fewer patients reported headache-related hospitalizations (p < 0.02) and HCP visits (p < 0.001) within the past 3 months than in the 3 months before baseline. In the German population, reductions were observed across all health services at all follow-up visits compared with baseline. The percentage of patients who saw a family doctor decreased from 41.7% at baseline to 13.5% at administration visit 8 and visits to a medical specialist decreased from 61.7% to 5.2% of patients. Inpatient acute treatment and technical diagnostics declined from 6.4% and 19.7% of patients at baseline to 0.0% and 1.0% at administration 8, respectively. The use of nonpharmacologic remedies and medication for the acute treatment of migraine also decreased with continued onabotulinumtoxinA treatment. Work incapacity, disability, absenteeism, and impaired performance at school/work improved with onabotulinumtoxinA treatment for CM over the 2-year observation period.

conclusionsReal-world evidence from REPOSE demonstrates that onabotulinumtoxinA treatment is associated with decreased HRU and supports the long-term benefits associated with the use of onabotulinumtoxinA for CM in clinical practice.

trial registrationNCT01686581 . Name of registry: ClinicalTrials.gov. URL of registry: Date of retrospective registration: September 18, 2012. Date of enrolment of first patient: July 23, 2012.

Indexed as

Botulinum Toxins, Type AMigraine DisordersAdultChronic DiseaseFemaleGermanyHumansItalyMaleNorwayProspective StudiesRetrospective StudiesSpainSwedenTreatment OutcomeBotulinum Toxins, Type ABurdenChronic migraineEconomicHeadacheHealthcareHealthcare resource utilizationOnabotulinumtoxinA

Identifiers

PMID34078259
PMCPMC8173963
OpenAlexW3164812668

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.