Dupilumab, ruxolitinib deliver benefits to atopic dermatitis patients

Treatment with dupilumab increases the levels of bone alkaline phosphatase (BALP), a marker of bone mineralization, in paediatric patients with moderate-to-severe atopic dermatitis (AD), regardless of asthma comorbidity, reports a study presented at ACAAI 2023.

“Low BALP levels and bone mineral density seen in children with moderate-to-severe AD, combined with chronic exposure to inhaled corticosteroid (ICS) from ICS-treated comorbid asthma, could contribute to a higher lifetime risk of fractures and osteoporosis, as well as ICS-related growth retardation, compared with healthy children,” said the investigators, led by Alan Irvine, consultant dermatologist at Children’s Health Ireland and at St James’s Hospital, and professor of dermatology at Trinity College Dublin, Ireland.

Irvine and colleagues conducted a retrospective analysis to assess the impact of dupilumab on BALP levels in children aged 6 to <12 years with moderate-to-severe AD, with and without comorbid asthma. Participants came from two phase III trials, namely LIBERTY AD PEDS (NCT03345914) and LIBERTY AD PED-OLE (NCT02612454). BALP levels were assessed at baseline and at weeks 8, 12, 16, and 52.

Dupilumab treatment resulted in a significant increase in geometric mean levels of BALP in children with moderate-to-severe AD at 16 weeks, regardless of asthma comorbidity, compared with those who received placebo (with asthma: 100/200 mg Q2W, n=63, p<0.0001; 300 mg Q4W, n=58, p<0.001; without asthma: 100/200 mg Q2W, n=59, p<0.05; 300 mg Q4W, n=64, p<0.01). [ACAAI 2023, abstract D010]

At week 52, BALP levels increased from baseline and were comparable with reference intervals for patients with and without asthma (with asthma: placebo vs placebo transitioned to dupilumab, n=60, p=0.0001; 100/200 mg Q2W, n=59, p<0.01; 300 mg Q4W, n=64, p<0.001; without asthma: placebo vs placebo transitioned to dupilumab, n=63, p=0.0001; 100/200 mg Q2W, p<0.001; 300 mg Q4W, p<0.01).

“Overall results suggest an increase in BALP [levels] in paediatric patients with moderate-to-severe AD, regardless of asthma comorbidity, following dupilumab treatment,” the investigators said.

Disease control

In terms of long-term disease control, another study presented at ACAAI 2023 reported the beneficial effects of as-needed ruxolitinib cream monotherapy over a 44-week period in adults and adolescents with AD, indicating a potential reduction in the need for therapy escalation. [ACAAI 2023, abstract D020]

In the 12 months preceding study enrolment, a mean of 5.1 recurrent AD flares occurred in 428 patients initially randomized to receive 1.5% ruxolitinib cream. Of these, 67.1 percent and 77.8 percent achieved an Investigator's Global Assessment (IGA) score of 0/1 at weeks 8 and 52, respectively.

For patients who completed treatment until week 52 (n=244), the median cumulative time off treatment due to lesion clearance increased from 25.0 percent (week 8‒12) to 43.9 percent (week 8‒52). The median time to mild or worse disease (IGA ≥2) was 36.1 weeks among patients achieving IGA 0/1 at week 8 with as-needed ruxolitinib cream. Similar results were seen with 0.75% ruxolitinib cream.

Ruxolitinib is a Janus kinase (JAK) 1/JAK2 inhibitor.