Table 1.
Topic area | Statement | Voting Results (Bayesian estimate [95% credibility interval]) | |
---|---|---|---|
Section 1. Treatment Initiation and Maintenance | 1.1 Transitioning from conventional systemic therapy to dupilumab | 1.1.1. Concurrent treatment with traditional systemic therapy and dupilumab does not alter either drug’s intrinsic risk profile | 97.8% (97.1–98.2%) |
1.1.2. When initiating dupilumab, concurrent systemic therapies may be tapered according to clinical response following dupilumab introduction, except in cases of adverse event or intolerance to traditional systemic agent necessitating withdrawal as abruptly as permitted relative to the safety issue | 98.6% (98.3–99.3%) | ||
1.2 Evaluation and maintenance of patients with AD on dupilumab | 1.2.1. For patients with adequate clinical response to dupilumab, continued use at the approved dose regimen will provide optimal long-term benefit, unless PROs fail to improve | 96.2% (95.4–96.9%) | |
1.2.2. For patients who do not achieve clinical improvement in AD by week 16–24, re-evaluation of diagnosis and alternative treatment may improve outcome | 98.4% (97.4–98.8%) | ||
1.3 Management of partial or non-durable responders and concomitant systemic therapies | 1.3.1. Increasing to weekly dosing may be considered in patients with partial or non-durable response to dupilumab | 92.7% (90.0–94.9%) | |
1.3.2. For patients not achieving adequate response on dupilumab, the addition of a traditional systemic agent may provide benefit | 98.3% (97.3–98.7%) | ||
Section 2. Special Populations | 2.1 Pregnancy and breastfeeding | 2.1.1. Dupilumab exposure during pregnancy poses little risk to mother and fetus | 89.9% (86.3–92.9%) |
2.1.2. There is negligible absorption of dupilumab by infants who are breast fed by women taking dupilumab | 97.0% (96.1–97.9%) | ||
2.2 Malignancy | 2.2.1. There is no known additional risk in treating patients with prior malignancy and most active malignancies with dupilumab. Exclusion of CTCL prior to dupilumab initiation is an important safety consideration | 92.7% (90.1–94.9%) | |
2.3 Patients with pre-existing immune disorders | 2.3.1. Dupilumab is unlikely to increase risks associated with pre-existing immune disorders including patients with HIV, patients with HIES, and organ transplant recipients. Drug-drug interactions are an important consideration when using traditional systemic agents in patients with pre-existing immune disorders | 95.6% (94.2–97.0%) | |
2.4 AD in older adults | 2.4.1. Dupilumab has no additive safety concerns in older patients with AD and should be considered preferential to traditional systemic agents where contraindications, polypharmacy, and co-existing conditions complicate their use | 95.2% (94.0–96.8%) | |
2.4.2. A confirmed diagnosis of AD in older adults with atypical presentation, especially to rule out CTCL, is crucial before initiating any systemic therapy, including dupilumab | 95.8% (94.9–96.9%) | ||
2.5 Patients with suspected or confirmed COVID-19 infection | 2.5.1. Dupilumab may be continued in patients with COVID-19 | 91.7% (88.8–94.1%) | |
2.5.2 Dupilumab is unlikely to impact COVID-19 vaccine effectiveness and is not associated with additional safety risk | 92.8% (89.2–95.5%) | ||
Section 3. Management of Potential Adverse Events | 3.1 Conjunctivitis | 3.1.1. Prophylactic measures such as artificial tears may reduce the incidence of conjunctivitis in patients with AD taking dupilumab | 92.8% (92.0–94.1%) |
3.2 Recalcitrant head and neck dermatitis | 3.2.1. Dupilumab-associated recalcitrant head and neck dermatitis may respond to short courses of low- to mid-potency topical steroids, topical calcineurin inhibitors and/or topical ketoconazole without dupilumab interruption | 98.4% (98.2–99.1%) | |
3.2.2. A short course of itraconazole or adjunct systemic therapy has provided benefit in some patients not responding to topical therapy | 81.8% (75.8–87.0%) | ||
3.3. Psoriasis | 3.3.1. Psoriasiform eruption has been reported in patients receiving dupilumab for AD. Most cases are localized and can be managed with topical anti-psoriatic therapy without dupilumab discontinuation | 85.7% (80.3–90.2%) | |
3.4. Arthrosis | 3.4.1. Arthrosis and arthralgia are rare in patients receiving dupilumab, and their association with dupilumab therapy is uncertain | 86.7% (82.9–90.0%) |
Please see S1 in the electronic supplementary material for details on the Individual and composite agreement plots of panelists including calculation of mean and Bayesian estimates
AD atopic dermatitis, CTCL cutaneous T-cell lymphoma, HIV human immunodeficiency virus, HIES hyper-IgE syndrome, COVID-19 coronavirus disease of 2019