Development and Validation of the Inclusion Body Myositis-Health Index: A Disease-Specific Patient-Reported Outcome Measure for Use in Clinical Trials and Drug-Labeling Claims.

Irwin, Charlotte; Rosero, Spencer; Seabury, Jamison; Weinstein, Jennifer; Engebrecht, Charlotte; Varma, Anika; Zizzi, Christine; Heatwole, John; Bhagchandani, Perya; Gibson, Cynthia; Dilek, Nuran; Martens, Bill; Heatwole, Chad

doi:10.1097/CND.0000000000000564

Development and Validation of the Inclusion Body Myositis-Health Index: A Disease-Specific Patient-Reported Outcome Measure for Use in Clinical Trials and Drug-Labeling Claims.

2026-06-03, Journal of clinical neuromuscular disease (10.1097/CND.0000000000000564) (online)
Charlotte Irwin, Spencer Rosero, Jamison Seabury, Jennifer Weinstein, Charlotte Engebrecht, Anika Varma, Christine Zizzi, John Heatwole, Perya Bhagchandani, Cynthia Gibson, Nuran Dilek, Bill Martens, and Chad Heatwole (?)

As novel therapeutic interventions are considered for individuals with inclusion body myositis (IBM), valid outcome measures are needed to quantify therapeutic gain and disease progression during clinical trials. To meet this need, we developed and validated the Inclusion Body Myositis-Health Index (IBM-HI), a regulatory-grade, disease-specific, patient-reported outcome measure capable of measuring a patient's perception of their point-in-time disease burden.

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Development and Validation of the Inclusion Body Myositis-Health Index: A Disease-Specific Patient-Reported Outcome Measure for Use in Clinical Trials and Drug-Labeling Claims.