Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2026
Determining the minimal important difference of EQ-5D-5 L utility values in CIDP patients using data from a large clinical trial.
Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is a rare autoimmune disorder characterized by limb weakness and sensory disturbances. This study aimed to estimate the minimal important difference (MID) of EQ-5D-5 L utility values in CIDP patients.
methodsADHERE, the largest CIDP trial to date, demonstrated the efficacy of efgartigimod. In Stage A (open-label; n = 322), patients received efgartigimod for up to 12 weeks or until evidence of clinical improvement (ECI). Patients with ECI entered Stage B, receiving efgartigimod (n = 111) or placebo (n = 110) for up to 48 weeks. An open-label extension (OLE) included 229 patients treated for up to 48 weeks. Disability was assessed using the adjusted INCAT (aINCAT) score (0-10). EQ-5D-5 L and aINCAT were recorded at baseline and end of Stage A. Perceived improvement was captured using the Patient Global Impression of Change (PGIC). Anchor-based methods were applied to estimate the MID: mean utility change for patients reporting "a little better" on PGIC; mean utility change in patients with a 1-point aINCAT decrease; regression of utility change versus aINCAT change; receiver-operating characteristic (ROC) curve. A distribution-based estimate was also derived (0.5x baseline SD).
resultsMID estimates were 0.11 (PGIC), 0.14 (1-point aINCAT decrease), 0.10 (regression), 0.10 (ROC), and 0.14 (distribution-based). In the OLE, 66.5% of patients achieved the MID by week 12 (n = 188).
conclusionThe PGIC-based MID (0.11) aligns with estimates in other conditions and supports interpretation of utility changes in future evaluations. Most patients in the OLE achieved this threshold, indicating sustained quality-of-life improvement with efgartigimod.
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