Patients with AD and a comorbid allergic condition achieved the same efficacy endpoints as patients without allergic conditions in a study.
Abrocitinib is efficacious in patients with atopic dermatitis (AD) and comorbid allergic conditions such as asthma, conjunctivitis, and rhinitis, according to a recent post hoc analysis published in Allergy.
The post hoc analysis reviewed data from 3 monotherapy trials, 1 (NCT02780167) being a phase 2b trial and 2 (NCT03349060, NCT03575871) being phase 3 trials. In these trials, patients with AD were treated with a 100 mg or 200 mg dose of abrocitinib or a vehicle control.
Investigators of the analysis sought to explore the efficacy of abrocitnib in patients with AD and comorbid allergic conditions, noting that efficacy has not been analyzed in the relationship between abrocitinib and comorbid status.
Patients involved in the previous studies were 18 (phase 2b) or 12 (phase 3) years of age and older with a moderate-to-severe AD diagnosis and an inadequate response to prior topical therapy, including an inability to receive treatment with topical therapies.
In all 3 studies, patients were randomly assigned to receive a once-daily dose of abrocitinib (specified dosage) or the placebo for a 12-week study period. The post hoc analysis only included patient data from those who had been treated with the placebo or a 100 mg or 200 mg dose of abrocitinib, as opposed to alternate dosing (30 mg or 10 mg) in the phase 2b trial.
Efficacy of abrocitinib in the post hoc analysis was analyzed from baseline to week 12 of the trials. In this case, efficacy was also determined based on the percentage of patients with and without comorbid allergic conditions who had achieved Investigator's Global Assessment (IGA) response of 0 or 1, indicative of clear or almost clear skin.
Efficacy was also based on the proportion of patients achieving clearance as determined by the Eczema Area and Severity Index (EASI), Pruritus or PP-NRS, Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), SCORing Atopic Dermatitis (SCORAD), and Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) scales.
At weeks 0, 2, 4, 8, and 12, eosinophil levels were measured and assessed. Throughout the respective studies, safety and treatment-emergent adverse events (TEAE) were monitored.
In total, 53% (n=498) of patients in the pooled population (n=942) self-reported the presence of an allergic comorbidity, the most common of which included allergic asthma, food allergies, allergic conjunctivitis, allergic rhinitis, or a combination of multiple allergic conditions.
At baseline, the cohort of patients with allergic comorbidities had, on average, more severe disease and were less likely to have adult-onset AD than the cohort of patients without a comorbid allergic condition.
Regardless of whether patients reported the presence of comorbidities, a higher percentage of patients who had been treated with abrocitinib in either dosing achieved clearance determined by IGA 0/1, PP-NRS4, DLQI 0/1, EASI-50, EASI-75, or EASI-90 responses as early as 2 weeks into the trials. Furthermore, these responses were maintained through week 12. Additionally, in both patient cohorts, those treated with abrocitinib experienced greater changed in SCORAD, POEM, and PSAAD scores from baseline compared to those treated with the placebo.
TEAE were reported as being mostly mild to moderate in nature with a 9% greater proportion of patients with allergic comorbidities experiencing common TEAE, such as nausea, nasopharyngitis, upper respiratory tract infection, and headache.
"This post hoc analysis suggests that abrocitinib is efficacious and well tolerated in patients with moderate-to-severe AD with and without allergic comorbidities," wrote study authors. "Thus, abrocitinib can be considered as a treatment option for AD regardless of the presence of allergic comorbidities."
Schmid-Grendelmeier P, Gooderham M, Hartmann K, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies. Allergy. https://doi.org/10.1111/all.15952