The current treatment landscape in adult atopic dermatitis in the United States: results from a cross-sectional real-world study

Background This study describes the current treatment landscape in adult atopic dermatitis (AD), overall and by disease severity. Methods Adult patients with an AD diagnosis in dermatology-specific electronic medical records during 2018 were identified and linked to an administrative claims database. Disease severity was determined using Physician’s Global Assessment (PGA). Written and dispensed prescriptions, within and between class cycling for AD therapies occurring in 2018 were assessed. Results In total, 4,364 patients were included. Among patients with available PGA, 43.2% had clear-to-mild, 37.3% had moderate, and 19.6% had severe disease. Most patients (71.0%) had written prescriptions for topical therapies only in 2018. Among the patients with claims for topical therapies alone, 80.7% used topical corticosteroids only. Within and between class cycling was observed in 33.7% and 12.8% of topical users, respectively. In patients with systemic therapy (40.6%), nearly 84.9% also used topical therapy, 25.8% cycled within systemic drug classes, and 24.8% cycled between systemic drug classes. Overall, cycling was more prevalent in patients with more severe disease. Conclusion Cycling within and between both topical and systemic drug classes was more common in patients with more severe disease, indicating difficulty of managing these patients and highlighting a need for more treatment options

Inadequate response and treatment patterns in adults diagnosed with atopic dermatitis and treated with topical therapy

Background Treatment for atopic dermatitis (AD) is complex, particularly in patients with inadequate response to topical therapies. Currently, there is little clinical guidance for the treatment of these patients. Methods A real-world retrospective study utilizing electronic medical records (EMR) and administrative claims data selected patients with AD between January 01 2016 and June 30 2018. Patients had a written prescription for a topical therapy (first observed script = index date) and no prior systemic treatment. Disease severity at index, follow-up treatment response and prescriptions patterns were assessed. A subset of patients linked to claims was evaluated for treatment patterns. Results We identified 137,214 adult topical-treated AD patients with no prior systemic therapy. Among the 16,035 patients with available Physician Global Assessment (PGA) at index, 8169 (50.9%) had the moderate-to-severe disease. Among these patients, 60% had an inadequate response to topical therapy. Of 4475 patients linked to claims, 13.0% had claims for systemic therapy during follow-up, most initiated systemic steroids (95.2%), and oral immunosuppressants and biologics were initiated in 3.3% and 3.8%, respectively. Conclusion In this real-world study, inadequate response to topical therapy among moderate-to-severe AD patients was high and initiation of systemic treatment was low which suggests a need for additional AD-indicated systemic treatment options in this patient population

Disease response and patient-reported outcomes among initiators of ixekizumab

Objectives There is limited real-world evidence on using ixekizumab in psoriasis patients. Therefore, we characterized patients with psoriasis initiating ixekizumab and report 6-month changes in disease and patient-reported outcomes. Methods Adult patients with psoriasis who initiated ixekizumab and completed a 6-month follow-up visit were enrolled from the Corrona Psoriasis Registry. Disease characteristics and outcomes were assessed at ixekizumab initiation. Outcomes included the mean 6-month change in Psoriasis Area and Severity Index (PASI), body surface area (BSA), Investigator Global Assessment (IGA), and IGA*BSA. Results From baseline to follow-up in all patients (n = 136), means decreased for IGA*BSA (−45.5) and BSA (−12.4), and a higher % achieved an absolute PASI ≤ 5 (84.6%), BSA 0–3 (72.1%), and IGA 0/1 (50.7%). Within stratified groups, means decreased for PASI <12 for IGA*BSA (−21.1) and BSA (−6.3); PASI≥12 for IGA*BSA (−94.8) and BSA (−24.6); weight <100 kg for IGA*BSA (−45.1) and BSA (−12.4); weight ≥100 kg for IGA*BSA (−46.2) and BSA (−12.3); concomitant PsA for IGA*BSA (−56.0) and BSA (−15.3); and in no concomitant PsA for IGA*BSA (−36.9) and BSA (−10.0). Conclusions We provide real-world evidence on the benefits of ixekizumab for treating psoriasis, regardless of baseline disease severity, weight, or concomitant PsA

Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5)

Background: Baricitinib, an oral selective Janus kinase 1/Janus kinase 2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults. Objective: To evaluate the efficacy and safety of baricitinib monotherapy in a North American phase 3 trial (BREEZE-AD5/NCT03435081) of adults with moderate-to-severe AD who responded inadequately or were intolerant to topical therapy. Methods: Patients (N = 440) were randomized 1:1:1 to once-daily placebo or baricitinib (1 mg or 2 mg). The primary endpoint was the proportion of patients achieving ≥75% reduction in the Eczema Area and Severity Index at week 16. A key secondary endpoint was the proportion of patients achieving a validated Investigator Global Assessment for AD score of 0 (clear)/1(almost clear) with ≥2-point improvement. Results: At week 16, the proportion of patients achieving Eczema Area and Severity Index was 8%, 13%, and 30% (P \u3c.001, 2 mg vs placebo) and those with a validated Investigator Global Assessment for AD score of 0/1 were 5%, 13%, and 24% (P \u3c.001, 2 mg vs placebo) for placebo, baricitinib 1 mg, and baricitinib 2 mg, respectively. Safety findings were similar to those of other baricitinib AD studies. Limitations: Short-term clinical trial results may not be generalizable to real-world settings. Conclusion: Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks