A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: Many options, no standards

Futamura, Masaki; Leshem, Yael Anne; Kim, Thomas; Nankervis, Helen; Williams, Hywel C; Simpson, Eric L.

doi:10.1016/j.jaad.2015.09.062

Cited by 187 publications

(180 citation statements)

References 28 publications

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“…Both instruments consider the intensity of erythema, oedema/papulation, excoriation, and lichenification. The oSCORAD index also includes the intensity of oozing/crusting and dryness of unaffected skin [14] . The IGA has never been inaugurated as an outcome measurement.…”

Section: Discussionmentioning

confidence: 99%

Assessment of Intra- and Inter-Rater Reliability of Three Methods for Measuring Atopic Dermatitis Severity: EASI, Objective SCORAD, and IGA

Bożek

Reich²

2017

Dermatology

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Background: Numerous different scoring systems have been proposed for assessing the severity of atopic dermatitis (AD). Many of these methods did not undergo proper validation and reliability testing. Objective: The aim of our study was to compare the reliability and reproducibility of the Eczema Area and Severity Index (EASI), objective Scoring Atopic Dermatitis (oSCORAD), and Investigator Global Assessment (IGA). Methods: On the scoring day, 10 trained dermatologists evaluated 10 adult patients with AD using the EASI, oSCORAD, and IGA. All subjects were assessed twice by each physician. Correlations between measures were analysed using the Pearson correlation coefficient. The intra-class correlation coefficient (ICC) was calculated to assess intra-rater reliability; the coefficient of variation (CV) was used to assess inter-rater variability. Results: Significant positive correlations were observed between each scale in both assessments. The ICCs for the EASI and oSCORAD were 0.71 and 0.66, respectively, indicating good reliability, while the ICC for the IGA (0.54) indicated only fair reliability. The CVs for the oSCORAD and IGA were 28.1 and 33.0, respectively, indicating moderate variability. The CV for the EASI was 66.5, indicating high variability. Conclusion: Among the 3 compared scales, the oSCORAD had the highest inter-rater reliability, whereas the EASI had the highest intra-rater reliability. None of the 3 scoring methods showed a significant advantage over the other. Thus, a reliable assessment of AD severity requires the use of at least 2 independent measurements simultaneously.

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Section: Discussionmentioning

confidence: 99%

Assessment of Intra- and Inter-Rater Reliability of Three Methods for Measuring Atopic Dermatitis Severity: EASI, Objective SCORAD, and IGA

Bożek

Reich²

2017

Dermatology

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“…The primary end point was the proportion of patients with an IGA score of 0 or 1 (clear or almost clear) 20 and a reduction from baseline of at least 2 points in the score at week 16. The proportion of patients who had an improvement from baseline at week 16 of at least 75% on the Eczema Area and Severity Index (EASI-75) was a key secondary end point (and was identified as a coprimary end point by regulators in the European Union and Japan).…”

Section: End Pointsmentioning

confidence: 99%

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis

2017

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“…Properly designed global assessment scores are acceptable as outcome measures for establishing primary endpoints in clinical trials for some dermatologic conditions, 16 such as atopic dermatitis, psoriasis, and acne. Global assessments have also been used in studies for infantile hemangioma, 17 which is also not life-threatening, but does result in disfigurement and functional deficits, and has a negative influence on the patient's psyche.…”

Section: Assessment Of Tumor Number and Sizementioning

confidence: 99%

“…Differences between global assessment scales for a specific condition underscore the need for standardization among investigators within the field such that data may be compared across studies. 16 Currently, there is not a global assessment scale for cNF, and thus development of such a scoring system is an unmet need for clinical research in this area. Effect on patient well-being Patient-reported outcomes (PROs) are likely to be important in the assessment of therapeutic efficacy for cNF to provide information regarding the patients' perceived burden of disease, benefit of an intervention, or burden of drug toxicity.…”

Section: Assessment Of Tumor Number and Sizementioning

confidence: 99%

Clinical trial design for cutaneous neurofibromas

et al. 2018

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Objective Several clinical trials targeting cutaneous neurofibromas (cNF) have been conducted; however, none has resulted in meaningful changes to care. The Clinical Trial Design and Development subgroup's goals were to (1) define key considerations in the design of clinical trials for cNF, (2) summarize existing data in relation to these considerations, and (3) provide consensus recommendations about key elements of trial design to accelerate the clinical development of therapies for cNF. MethodsThe subgroup, with experts from genetics, dermatology, neurology, oncology, and basic science, spanning academia, government research, and regulatory programs, and industry, reviewed published and unpublished data on clinical trials for cNF and other diseases in the skin. Discussions of these data resulted in formulation of a list of priority issues to address in order to develop efficient and effective clinical trials for cNF.

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A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: Many options, no standards

Cited by 187 publications

References 28 publications

Assessment of Intra- and Inter-Rater Reliability of Three Methods for Measuring Atopic Dermatitis Severity: EASI, Objective SCORAD, and IGA

Assessment of Intra- and Inter-Rater Reliability of Three Methods for Measuring Atopic Dermatitis Severity: EASI, Objective SCORAD, and IGA

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis

Clinical trial design for cutaneous neurofibromas

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