New Migraine Burden Index Proves Accurate, Strongly Correlates With Patient Satisfaction

Investigators conducted a 9-month study that demonstrated the correlation of the MBI, calculated as the sum of headache days times the maximum intensity of headache on each headache day, with satisfaction of migraine status.

Data from a recent study suggest that a new instrument, the Migraine Burden Index (MBI), is an accurate measure for assessing migraine-related clinical disability. These findings were presented at the 2021 Virtual American Headache Society (AHS) 63rd Annual Scientific Meeting, June 3-6, by Allison Koutsandreas, FNP-BC, headache center, George Washington Medical Faculty Associates.1

“We lack a simple standardized instrument for reliably assessing the clinical burden imposed by migraine,” Koutsandreas and colleagues wrote. In order to address this, they developed and evaluated the MBI, a novel instrument for assessing migraine burden, in a population of patients with migraine being treated with onabotulinumtoxinA (Botox; Abbvie).

The investigators calculated a baseline MBI using pretreatment headache diaries. They calculated the MBI as the sum of headache days times the maximum intensity of headache on each headache day, ranked from “1,” defined as mild headache/no limitation on activity; “2,” defined as moderate headache limiting but not prohibiting routine activity; and “3,” defined as headache prohibiting routine activity for at least 1 hour. The MBI score ranges from 0 to 90. The investigators also assessed patient satisfaction with their current migraine status according to a 5-point Likert scale and total headache and migraine days were recorded via the headache diaries.

Koutsandreas and colleagues administered at least 1 set of onabotulinumtoxinA injections to 170 patients with chronic migraine. Of these patients, 160 (94%) completed 3 treatments and were available for assessment at 9 months. These patients had a baseline MBI score of 30.7 and a baseline Likert score of migraine status satisfaction of 1.8.

READ MORE: Medication Overuse Headache in Chronic Migraine Linked to High Burden

The investigators found that all patients that had reported a Likert score of 4 or 5 at month 9 (n = 108; 67.5%) recorded a reduction in MBI of at least 50% for month 8 of treatment relative to baseline. This reduction in MBI was a more sensitive predictor of patient satisfaction than reduction in total monthly headache days and monthly migraine days.

“In our population of chronic migraine patients treated with onabotulinumtoxinA, the MBI, an instrument blending headache frequency and severity, correlated more strongly with patient satisfaction than change in monthly headache days or monthly migraine days,” Koutsandreas and colleagues concluded.

Another recent investigation on migraine burden was the real-world, 6-month observational, non-interventional, ATTAIN study (Assessment of TolerabiliTy and Effectiveness in migrAINe Patients using Preventive Treatment) of 234 patients with episodic (EM) or chronic migraine (CM) initiating or changing preventive treatment at 28 primary care of neurology clinics in the US.2

The ATTAIN study found that 70.1% of patients studied had not used preventive treatments despite having an average of 9.6 (standard deviation [SD], 5.0) headache days per month. Patients that did use preventive treatments reported a lack of efficacy, leading to poor adherence. These patients (n = 70) had a mean 12.4 headache days (SD, 7.0) per month. The study collected data between March 2016 and October 2017, prior to the introduction of novel calcitonin gene-related peptide (CGRP) antagonists in 2018.

A majority of patients in the study had a severe Migraine Disability Assessment score, with 110 (67.1%) treatment-naïve patients and 54 (77.1%) treatment-experienced patients falling under this category. Similar results were seen in Headache Impact Test scores, with scores indicating severe impairment seen in 145 (88.4%) treatment-naïve and 62 (88.6%) treatment-experienced patients.

"Recent regulatory approvals for CGRP biologics, a new class of migraine preventive drugs, provide an additional treatment option with favorable efficacy and side effect profile with substantially lower discontinuation rates in clinical trials compared to other available oral preventive therapies. The rapidity of onset and favorable tolerability of CGRP biologics are attributes that promise to address the considerable limitations of previously available oral preventive options for migraine,” senior author Richard B. Lipton, MD, director, Montefiore Headache Center, and colleagues wrote in the paper.

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REFERENCES
1. Rothrock JF, Koutsandreas AK. “Migraine Burden Index”: A new instrument for assessing migraine-related clinical disability. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P135.
2. Kawata AK, Shah N, Poon JL, et al. Understanding the migraine treatment landscape prior to the introduction of calcitonin gene‐related peptide inhibitors: Results from the Assessment of TolerabiliTy and Effectiveness in MigrAINe Patients using Preventive Treatment (ATTAIN) study. Headache. doi: 10.1111/head.14053