Comparison of patient (POEM), observer (EASI, SASSAD, TIS) and corneometry measures of emollient effectiveness in children with eczema: findings from the COMET feasibility Trial

Abstract

Background

Eczema affects ~20% of children but multiple different outcome measures have hampered research into the effectiveness of different treatments.

Objectives

To compare the change in scores and correlations within and between five measures of eczema severity: Patient Orientated Eczema Measure (POEM), Eczema Area Severity Index (EASI), Six Area Six Sign Atopic Dermatitis (SASSAD), Three Item Severity (TIS), and skin hydration (corneometry).

Methods

Data from a feasibility trial that randomised young children with eczema to one of four emollients were used. Participants were followed for three months (84 days). Descriptive statistics (by emollient over time) and Spearman's correlation coefficients comparing scores at each time-point and absolute change (between adjacent time-points) for each outcome measure were calculated.

Results

197 children, mean age (SD) of 21.7 (12.8) months, were randomised. POEM and TIS appeared to capture a range of eczema severity at baseline but only POEM had close approximation to normal distribution. Mean POEM, EASI, SASSAD and TIS scores improved month-by-month, with POEM showing the greatest sensitivity (effect size 0.42). Correlations within POEM, EASI, SASSAD and TIS were moderate-to-good, decreasing over time. Correlations between measures were strongest for EASI, SASSAD and TIS. By contrast, corneometry scores were more variable, correlated less well over time, and were poorly correlated with the other measures.

Conclusions

Except for corneometry, all measures appear to change in relation to emollient use over time and correlate well with themselves. POEM demonstrated the greatest range of scores at baseline and change in eczema severity over the first 28 days.

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Cost-effectiveness of omalizumab for the treatment of Chronic Spontaneous Urticaria

Summary

Background

Chronic spontaneous urticaria (CSU) is a skin disease, with itchy hives and / or angioedema that last for at least 6 weeks without an obvious external trigger.

Objectives

The objective of this study was to determine the cost-effectiveness of omalizumab relative to standard of care (SoC; up to 4 times the daily dose of H1-antihistaminics) for the Netherlands from a societal perspective.

Methods

The Markov model used consisted of five health states based on Urticaria Activity Score over seven days (UAS7). Model settings and characteristics of the Dutch patient population were based on an online survey among clinical experts and were validated during an expert committee meeting. Transition probabilities were derived from the GLACIAL trial. Healthcare consumption, quality of life (using EQ-5D) and productivity losses were derived from a burden of illness study (ASSURE-CSU) among 93 Dutch patients. Healthcare consumption and productivity losses were valued using the Dutch costing manual. Comparator treatment was SoC, consisting of (up dosed) antihistamines. A ten-year time horizon was used.

Results

The incremental cost-effectiveness ratio (ICER) of omalizumab versus SoC was €17,502 per quality adjusted life year (QALY) gained. Productivity costs played an important role in the value of the ICER; discarding productivity costs resulted in an ICER of €85,310 per QALY.

Conclusions

Omalizumab is cost-effective compared to SoC. The outcomes of this study were used to establish omalizumab as third-line treatment in the Dutch treatment guidelines for CSU.

This article is protected by copyright. All rights reserved.

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A randomized split-scalp study comparing Calcipotriol assisted MAL-PDT with Conventional MAL-PDT for the treatment of Actinic Keratosis

Summary

Background

Topical photodynamic therapy (PDT) is an approved treatment for actinic keratosis (AK). To enhance the efficacy of PDT for AKs, physical (ablative lasers and microneedling) and chemical (pro-differentiating drugs) pretreatments have been suggested.

Objectives

To compare the efficacy and safety of the combination of topical calcipotriol (CAL) before methylaminolevulinate (MAL)-PDT for AKs of the scalp versus conventional MAL-PDT in a randomized controlled-clinical trial.

Materials and Methods

Twenty patients with multiple AKs on the scalp were randomized to receive conventional MAL - PDT with previous curettage on one side of the scalp and CAL – assisted MAL-PDT applied once a day for fifteen days before the illumination with red light-emitting diode (37J/cm²) on the other side. After three months, patients were evaluated for the clearance of AKs, side effects and histopathology before and after the procedure. Protoporphyrin IX (PpIX) fluorescence was measured before and after illumination on both sides.

Results

All twenty patients completed the study. Overall AK clearance was 92.07% and 82.04% for CAL-PDT and conventional PDT respectively (p< 0.001). The AKs grade I showed similar response rate of 92.83% and 87.29% (p=0.055) respectively for CAL and MAL-PDT sides. However, AKs grade II showed more improvement on the CAL-PDT side (89.55%) compared with MAL-PDT (62.90%) (p<0.001). Before illumination, PpIX fluorescence intensity was higher on the CAL-assisted side (p=0.048). The treatment was more painful on the CAL-PDT side, although well tolerated. The mean VAS score was 5.40±1.43 on the CAL-PDT side and 3.95±0.69 on the conventional MAL-PDT side (p=0.001). Side effects such as erythema (p=0.019), edema (p=0.002), crusts (p<0.001) were more pronounced on the CAL-assisted side. Histopathological analyses were obtained from five patients and both sides showed improved keratinocyte atypia following PDT, with a slight more improvement on CAL- assisted side.

Conclusion

CAL-assisted PDT proved to be safe and more effective than conventional MAL-PDT for the treatment of AKs on the scalp. CAL pretreatment increased PpIX accumulation within the skin and may have enhanced the efficacy in this first human trial. As this is the first CAL-assisted PDT study in human skin, further and larger trials are needed to corroborate our findings.

This article is protected by copyright. All rights reserved.

http://ift.tt/2EOz6nT

Comparison of patient (POEM), observer (EASI, SASSAD, TIS) and corneometry measures of emollient effectiveness in children with eczema: findings from the COMET feasibility Trial

Abstract

Background

Eczema affects ~20% of children but multiple different outcome measures have hampered research into the effectiveness of different treatments.

Objectives

To compare the change in scores and correlations within and between five measures of eczema severity: Patient Orientated Eczema Measure (POEM), Eczema Area Severity Index (EASI), Six Area Six Sign Atopic Dermatitis (SASSAD), Three Item Severity (TIS), and skin hydration (corneometry).

Methods

Data from a feasibility trial that randomised young children with eczema to one of four emollients were used. Participants were followed for three months (84 days). Descriptive statistics (by emollient over time) and Spearman's correlation coefficients comparing scores at each time-point and absolute change (between adjacent time-points) for each outcome measure were calculated.

Results

197 children, mean age (SD) of 21.7 (12.8) months, were randomised. POEM and TIS appeared to capture a range of eczema severity at baseline but only POEM had close approximation to normal distribution. Mean POEM, EASI, SASSAD and TIS scores improved month-by-month, with POEM showing the greatest sensitivity (effect size 0.42). Correlations within POEM, EASI, SASSAD and TIS were moderate-to-good, decreasing over time. Correlations between measures were strongest for EASI, SASSAD and TIS. By contrast, corneometry scores were more variable, correlated less well over time, and were poorly correlated with the other measures.

Conclusions

Except for corneometry, all measures appear to change in relation to emollient use over time and correlate well with themselves. POEM demonstrated the greatest range of scores at baseline and change in eczema severity over the first 28 days.

This article is protected by copyright. All rights reserved.

http://ift.tt/2ERsPrN

Cost-effectiveness of omalizumab for the treatment of Chronic Spontaneous Urticaria

Summary

Background

Chronic spontaneous urticaria (CSU) is a skin disease, with itchy hives and / or angioedema that last for at least 6 weeks without an obvious external trigger.

Objectives

The objective of this study was to determine the cost-effectiveness of omalizumab relative to standard of care (SoC; up to 4 times the daily dose of H1-antihistaminics) for the Netherlands from a societal perspective.

Methods

The Markov model used consisted of five health states based on Urticaria Activity Score over seven days (UAS7). Model settings and characteristics of the Dutch patient population were based on an online survey among clinical experts and were validated during an expert committee meeting. Transition probabilities were derived from the GLACIAL trial. Healthcare consumption, quality of life (using EQ-5D) and productivity losses were derived from a burden of illness study (ASSURE-CSU) among 93 Dutch patients. Healthcare consumption and productivity losses were valued using the Dutch costing manual. Comparator treatment was SoC, consisting of (up dosed) antihistamines. A ten-year time horizon was used.

Results

The incremental cost-effectiveness ratio (ICER) of omalizumab versus SoC was €17,502 per quality adjusted life year (QALY) gained. Productivity costs played an important role in the value of the ICER; discarding productivity costs resulted in an ICER of €85,310 per QALY.

Conclusions

Omalizumab is cost-effective compared to SoC. The outcomes of this study were used to establish omalizumab as third-line treatment in the Dutch treatment guidelines for CSU.

This article is protected by copyright. All rights reserved.

http://ift.tt/2FtUpwi

A randomized split-scalp study comparing Calcipotriol assisted MAL-PDT with Conventional MAL-PDT for the treatment of Actinic Keratosis

Summary

Background

Topical photodynamic therapy (PDT) is an approved treatment for actinic keratosis (AK). To enhance the efficacy of PDT for AKs, physical (ablative lasers and microneedling) and chemical (pro-differentiating drugs) pretreatments have been suggested.

Objectives

To compare the efficacy and safety of the combination of topical calcipotriol (CAL) before methylaminolevulinate (MAL)-PDT for AKs of the scalp versus conventional MAL-PDT in a randomized controlled-clinical trial.

Materials and Methods

Twenty patients with multiple AKs on the scalp were randomized to receive conventional MAL - PDT with previous curettage on one side of the scalp and CAL – assisted MAL-PDT applied once a day for fifteen days before the illumination with red light-emitting diode (37J/cm²) on the other side. After three months, patients were evaluated for the clearance of AKs, side effects and histopathology before and after the procedure. Protoporphyrin IX (PpIX) fluorescence was measured before and after illumination on both sides.

Results

All twenty patients completed the study. Overall AK clearance was 92.07% and 82.04% for CAL-PDT and conventional PDT respectively (p< 0.001). The AKs grade I showed similar response rate of 92.83% and 87.29% (p=0.055) respectively for CAL and MAL-PDT sides. However, AKs grade II showed more improvement on the CAL-PDT side (89.55%) compared with MAL-PDT (62.90%) (p<0.001). Before illumination, PpIX fluorescence intensity was higher on the CAL-assisted side (p=0.048). The treatment was more painful on the CAL-PDT side, although well tolerated. The mean VAS score was 5.40±1.43 on the CAL-PDT side and 3.95±0.69 on the conventional MAL-PDT side (p=0.001). Side effects such as erythema (p=0.019), edema (p=0.002), crusts (p<0.001) were more pronounced on the CAL-assisted side. Histopathological analyses were obtained from five patients and both sides showed improved keratinocyte atypia following PDT, with a slight more improvement on CAL- assisted side.

Conclusion

CAL-assisted PDT proved to be safe and more effective than conventional MAL-PDT for the treatment of AKs on the scalp. CAL pretreatment increased PpIX accumulation within the skin and may have enhanced the efficacy in this first human trial. As this is the first CAL-assisted PDT study in human skin, further and larger trials are needed to corroborate our findings.

This article is protected by copyright. All rights reserved.

http://ift.tt/2EOz6nT

Editorial Board

Publication date: 1 March 2018
Source:Journal of Neuroscience Methods, Volume 297





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