Content Validity of HIT‐6 as a Measure of Headache Impact in People With Migraine: A Narrative Review

Houts, Carrie R.; Wirth, R.; McGinley, James S.; Gwaltney, Chad J.; Kassel, Eric; Snapinn, Steven; Cady, Roger

doi:10.1111/head.13701

Cited by 54 publications

(54 citation statements)

References 51 publications

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“…Enrolled patients were requested to carefully fill out a daily headache diary during a run-in month period (baseline) and the entire duration of the study, to report monthly migraine days (MMDs) for HFEM patients, all monthly headache days (MHDs) of at least moderate intensity for CM subjects, and monthly painkillers intake (MPI). Patients were also asked to rate pain severity (0–10 Numerical Rating Scale, NRS) of the monthly most painful attack and fill out migraine disability questionnaires (Headache Impact Test, HIT-6 [ 24 ], monthly, and the MIgraine Disability Assessing Scale [ 25 ], MIDAS, quarterly).…”

Section: Methodsmentioning

confidence: 99%

Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study)

et al. 2021

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Background The clinical benefit of galcanezumab, demonstrated in randomized clinical trials (RCTs), remains to be quantified in real life. This study aimed at evaluating the effectiveness, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic migraine (CM) in a real-life setting. Methods This multicenter prospective observational cohort study was conducted between November 2019 and January 2021 at 13 Italian headache centers. Consecutive adult HFEM and CM patients clinically eligible were enrolled and treated with galcanezumab subcutaneous injection 120 mg monthly with the first loading dose of 240 mg. The primary endpoint was the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients after 6 months of therapy (V6). Secondary endpoints were the Numerical Rating Scale (NRS), monthly painkiller intake (MPI), HIT-6 and MIDAS scores changes, ≥50% responder rates (RR), the conversion rate from CM to episodic migraine (EM) and Medication Overuse (MO) discontinuation. Results One hundred sixty-three patients (80.5% female, 47.1 ± 11.7 years, 79.8% CM) were included. At V6, MMDs reduced by 8 days in HFEM and MHDs by 13 days in CM patients (both p < .001). NRS, MPI, HIT-6 and MIDAS scores significantly decreased (p < .001). Ten patients (6.1%) dropped out for inefficacy and classified as non-responders. Patients with ≥50%RRs, i.e. responders, were 76.5% in the HFEM and 63.5% in the CM group at V6. Among CM patients, the V6 responders presented a lower body mass index (p = .018) and had failed a lower number of preventive treatments (p = .013) than non-responders. At V6, 77.2% of CM patients converted to EM, and 82.0% ceased MO. Adverse events, none serious, were reported in up to 10.3% of patients during evaluation times. Conclusions Galcanezumab in real life was safe, well tolerated and seemed more effective than in RCTs. Normal weight and a low number of failed preventives were positively associated with galcanezumab effectiveness in CM patients. Trial registration ClinicalTrials.govNCT04803513.

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Section: Methodsmentioning

confidence: 99%

Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study)

et al. 2021

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“…For both scales, the seven possible responses were categorized as “very much improved”, “much improved”, “minimally improved”, “no change”, “minimally worse”, “much worse”, or “very much worse”. The HIT-6 v1.0 [ 7 , 9 ]—which has been validated in patients with chronic migraine [ 10 – 12 ] —was administered at screening, day 0, and each study visit through week 32. Scores of ≥60 denote severe life impact, 56–59 indicate substantial life impact, 50–55 represent some life impact, and ≤ 49 demonstrates little or no life impact [ 13 ]; full details of the scoring system have been reported [ 6 ].…”

Section: Methodsmentioning

confidence: 99%

Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy–2) study

et al. 2020

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Background PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide–targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment. Methods Patients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32). Results A total of 1072 adults received treatment: eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366. The reduction in mean monthly migraine days observed during the first dosing interval (100 mg, − 7.7 days; 300 mg, − 8.2 days; placebo, − 5.6 days) was further decreased after an additional dose (100 mg, − 8.2 days; 300 mg, − 8.8 days; placebo, − 6.2 days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The ≥50% and ≥ 75% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (≥50% MRRs weeks 13–24: 100 mg, 61.0%; 300 mg, 64.0%; placebo, 44.0%; and ≥ 75% MRRs weeks 13–24: 100 mg, 39.3%; 300 mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events. Conclusion Eptinezumab 100 mg or 300 mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24 weeks and demonstrated an acceptable safety profile in patients with chronic migraine. Trial registration ClinicalTrials.gov (Identifier: NCT02974153). Registered November 23, 2016.

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“…It was conducted as part of two ongoing observational longitudinal multicentric studies on the real-life use of erenumab (the EARLY-ErenumAb in Real Life in ItalY-study) and galcanezumab (the GARLIT-GalcanezumAb in Real Life in ITaly-study), two monoclonal antibodies inhibiting the CGRP pathway, in different headache centers across Italy. The EARLY [3] and GARLIT [4] studies investigate the effectiveness of erenumab or galcanezumab, prescribed upon clinical indication [5], by prospectively collecting monthly migraine days (MMDs), monthly painkiller intake (MPI), and monthly disability scale (i.e., Headache Impact Test-HIT-6, Italian version 1.1). All patients were educated on the headache diary use at the beginning of the GARLIT and EARLY studies.…”

Section: Methodsmentioning

confidence: 99%

Locking down the CGRP pathway during the COVID-19 pandemic lockdown: the PandeMig study

et al. 2020

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Objectives The COVID-19 pandemic and the consequent lockdown came as a storm disrupting people's everyday life. This study aimed at observing whether the COVID-19 related lockdown influenced migraine frequency and disability in migraine patients on therapy with monoclonal antibodies inhibiting the CGRP pathway. Methods In this longitudinal observational cohort study, 147 consecutive patients receiving monthly administration of erenumab or galcanezumab were enrolled in four Italian headache centers. All patients filled a questionnaire concerning working and household settings, recent flu symptoms or COVID-19 diagnosis, and family loss due to COVID-19 infection. Monthly migraine days (MMDs), monthly painkiller intake (MPI), and HIT-6 disability relative to the first month of lockdown imposition (T-lock) and the month before (T-free) were also collected. Results From T-free to T-lock, the cohort displayed a reduction in MMDs (from 10.5 ± 7.6 to 9.8 ± 7.6, p = .024) and HIT-6 scores (from 59.3 ± 8.3 men reduced MPI more frequently than women (p = .005). Conclusions Our study observed that the lockdown impact to 57.8 ± 8.8, p = .009), while MPI resulted unchanged (from 11.6 ± 11.5 to 11.1 ± 11.7; p = .114). MMDs, MPI, and HIT-6 variations from T-free to T-lock did not differ according to work settings or household. Patients beyond the first 3 months of therapy presented less often a reduction in MMDs (p = .006) and on everyday life did not affect the migraine load in patients receiving monoclonal antibodies inhibiting the CGRP pathway. Patients in the first months of therapy experienced a greater improvement according to drug pharmacokinetics, while women more frequently needed rescue medications, possibly indicating presenteeism or cephalalgophobia.

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Content Validity of HIT‐6 as a Measure of Headache Impact in People With Migraine: A Narrative Review

Cited by 54 publications

References 51 publications

Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study)

Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study)

Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy–2) study

Locking down the CGRP pathway during the COVID-19 pandemic lockdown: the PandeMig study

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