Use of the Glucocorticoid Toxicity Index-Metabolic Domains Instrument to Quantify Glucocorticoid Toxicity in Adults With Chronic Inflammatory Demyelinating Polyneuropathy Using Electronic Health Records in the United States
Author(s)
CECILE BLEIN, PhD1, Clémence Arvin-Berod, PharmD1, John H. Stone, MD2, Swapna Karkare, MS3, Martha Stone, BA4, Rucha Kulkarni, MHS5, Yachendra Challa, BTech6, Pranav Moudgalya, BTech6, Anthony Nguyen, PhD7, Amit Goyal, MBA8;
1argenx BVBA, Ghent, Belgium, 2Harvard Medical School, Boston, MA, USA, 3argenx US, Inc, Boston, MA, USA, 4Steritas, Concord, MA, USA, 5ZS Associates, Consultant, Bethesda, MD, USA, 6ZS Associates, Bangaluru, India, 7ZS Associates, Evanston, IL, USA, 8ZS Associates, Princeton, NJ, USA
1argenx BVBA, Ghent, Belgium, 2Harvard Medical School, Boston, MA, USA, 3argenx US, Inc, Boston, MA, USA, 4Steritas, Concord, MA, USA, 5ZS Associates, Consultant, Bethesda, MD, USA, 6ZS Associates, Bangaluru, India, 7ZS Associates, Evanston, IL, USA, 8ZS Associates, Princeton, NJ, USA
Presentation Documents
OBJECTIVES: The Glucocorticoid Toxicity Index-Metabolic Domains (GTI-MD) is a validated clinical outcome assessment that quantifies change in steroid toxicity and has been applied in various contexts beyond clinical settings. The aim of this study is to assess the feasibility of adapting the GTI-MD for chronic inflammatory demyelinating polyneuropathy (CIDP) using retrospective data.
METHODS: This study utilized de-identified Optum® Market Clarity data (Jan 2007-Sep 2023) to identify adults with CIDP based on: (1) ≥2 CIDP claims, ≥30-≤365 apart, and (2) ≥1 nerve conduction test within 90 days of a confirmed CIDP diagnosis. Patients with >1 CIDP claim during the selection period (Jan 2014 - Jun 2022) were included. Steroid utilizers (CIDP-SU) were defined by first steroid claim (index date) after CIDP claim in selection period while steroid-naïve patients (CIDP-SN) were matched based on age, gender, days to steroid use from first CIDP diagnosis in selection period. The original GTI-MD criteria include body mass index, blood pressure, glucose levels, and lipid levels labs. Due to limited sample size, we adapted the criteria. Baseline characteristics including age (at index) and Charlson Comorbidity Index (CCI, 1-year pre-index) were assessed.
RESULTS: Among 14,070 identified CIDP patients, 134 CIDP-SU and 66 CIDP-SN patients met eligibility criteria for GTI-MD analysis. Mean (SD) age was 63.0 (11.5) for CIDP-SU and 62.2 (11.4) years for CIDP-SN, with CCI (SD) score of 3.5 (3.0) and 3.2 (2.7), respectively. Most common CIDP comorbidities identified in the CIDP-SU and CIDP-SN cohorts include neuropathic pain (74.6% and 72.7%), hypertension (71.6% and 69.7%), hypercholesterolemia (60.4% and 50.0%), and diabetes wo CC (53.0% and 62.1%).
CONCLUSIONS: Our results suggest that quantifying steroid toxicity using GTI-MD in patients with CIDP is feasible. The GTI-MD, an innovative tool, can be applied across settings (clinical trials, practice, and real-world-data analyses) to expand the body of evidence of steroid use in different diseases.
METHODS: This study utilized de-identified Optum® Market Clarity data (Jan 2007-Sep 2023) to identify adults with CIDP based on: (1) ≥2 CIDP claims, ≥30-≤365 apart, and (2) ≥1 nerve conduction test within 90 days of a confirmed CIDP diagnosis. Patients with >1 CIDP claim during the selection period (Jan 2014 - Jun 2022) were included. Steroid utilizers (CIDP-SU) were defined by first steroid claim (index date) after CIDP claim in selection period while steroid-naïve patients (CIDP-SN) were matched based on age, gender, days to steroid use from first CIDP diagnosis in selection period. The original GTI-MD criteria include body mass index, blood pressure, glucose levels, and lipid levels labs. Due to limited sample size, we adapted the criteria. Baseline characteristics including age (at index) and Charlson Comorbidity Index (CCI, 1-year pre-index) were assessed.
RESULTS: Among 14,070 identified CIDP patients, 134 CIDP-SU and 66 CIDP-SN patients met eligibility criteria for GTI-MD analysis. Mean (SD) age was 63.0 (11.5) for CIDP-SU and 62.2 (11.4) years for CIDP-SN, with CCI (SD) score of 3.5 (3.0) and 3.2 (2.7), respectively. Most common CIDP comorbidities identified in the CIDP-SU and CIDP-SN cohorts include neuropathic pain (74.6% and 72.7%), hypertension (71.6% and 69.7%), hypercholesterolemia (60.4% and 50.0%), and diabetes wo CC (53.0% and 62.1%).
CONCLUSIONS: Our results suggest that quantifying steroid toxicity using GTI-MD in patients with CIDP is feasible. The GTI-MD, an innovative tool, can be applied across settings (clinical trials, practice, and real-world-data analyses) to expand the body of evidence of steroid use in different diseases.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
RWD145
Topic
Real World Data & Information Systems
Disease
SDC: Neurological Disorders