Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families

Abstract

Introduction

The impact of crisaborole ointment, a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis (AD), on quality of life (QoL) was assessed in two identically designed phase 3 studies (AD-301: NCT02118766; AD-302: NCT02118792, both at http://www.clinicaltrials.gov).

Methods

In both studies, patients aged ≥ 2 years with mild to moderate AD per the Investigator's Static Global Assessment were randomly assigned 2:1 to receive crisaborole or vehicle twice daily for 28 days. QoL was assessed using the Children's Dermatology Life Quality Index (CDLQI) (2–15 years), the Dermatology Life Quality Index (DLQI) (≥ 16 years), and the Dermatitis Family Impact Questionnaire (DFI) (parents/caregivers/family of patients aged 2–17 years). Established QoL score severity bands provided clinical context.

Results

Greater mean improvement in QoL was observed in crisaborole-treated patients than in vehicle-treated patients at day 29 [mean change from baseline (∆BL), CDLQI: − 4.6 vs. − 3.0; P < 0.001; DLQI: − 5.2 vs. − 3.5; P = 0.015]. At baseline, more than half the patients had a "moderate effect" or higher of AD on QoL. At day 29, there was a trend toward more crisaborole- than vehicle-treated patients having "small effect" to "no effect", The QoL of parents/caregivers/family improved more for crisaborole-treated than for vehicle-treated patients (∆BL, DFI: − 3.7 vs. − 2.7; P = 0.003).

Conclusion

Crisaborole treatment results in clinically meaningful improvement in QoL for patients and their parents/caregivers/families.

Trial Registration

AD-301: http://www.clinicaltrials.gov, NCT02118766; AD-302: http://www.clinicaltrials.gov, NCT02118792.

Funding

Anacor Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., New York, NY.

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Publication date: Available online 21 October 2018

Source: Oral Oncology

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Description  

A 75-year-old woman presented with a 3-week history of escalating nocturnal neuropathic pain affecting her left thigh. This pain was described as sharp and 'shooting' in nature, primarily in the upper outer part of her thigh, with a severity of '10/10' at its worst. She had a medical history of osteoarthritis, hypercholesterolaemia, paroxysmal atrial fibrillation, a complete left bundle branch block with normal cardiac function and intestinal metaplasia for which she was undergoing regular endoscopic surveillance. She provided a strong family history of malignancy, with colorectal cancer in her sister, ovarian cancer in her mother, oesophageal cancer in her father, and lung and prostate cancer in her brother. Of note, in this time she had not experienced any trauma, fevers, fatigue, altered bowel habits, or weight loss.

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Description  

An 11-year-old girl presented with global developmental delay. As part of her routine work-up for her developmental disability, MRI of the brain was performed and demonstrated a contrast-enhancing lesion with reduced diffusivity in the right parietal lobe (figure 1). A stereotactic robotic-assisted needle biopsy revealed microglial proliferation and lymphocytic inflammation, indicating potential microglioma or gliofibroma; however, a more definitive diagnosis was not established given the limited tissue. Early repeat MRI showed areas of progression, and gross total resection was performed. The pathology demonstrated a moderately cellular proliferation of spindle cells with scattered mitotic figures, and a mixed inflammatory infiltrate of scattered lymphocytes, plasma cells and eosinophils (figure 2A). The areas of nodular spindle cell proliferation were diffusely immunopositive for CD68 and negative for CD30, CD34, smooth muscle actin, desmin, S100, CD1a, CD117, CD3, CD20, CD15, synaptophysin, glial fibrillary acidic protein (GFAP) and leucocyte...

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