Comorbid health disorders
Comorbid health disorders linked to AD are varied and include atopic comorbidities such as asthma or wheeze, hay fever or oculonasal symptoms, food allergy, recurrent infections such as herpes simplex virus, mental health disorders, alopecia areata, Th1-mediated comorbidities, and adverse events to medication such as venous thromboembolism, hypertension, and impaired renal or liver function. “All of these are important because if the patients have these at baseline, they may not be good candidates for some therapies that cause these types of side effects,” Dr. Silverberg said.
Response to therapy, intensity of lesions
As for response to therapy, clinicians can ask patients, “How do you feel you’re improving?” But it’s also important to assess the signs, symptoms, frequency of flares, and comorbidities as part of that response to therapy, “and of course the adverse events and treatment burden,” he said.
For the intensity of lesions component of DESCRIBE-AD, Dr. Silverberg said that the Investigator’s Global Assessment–AD is an effective tool for clinical use. “You can also use tools like the Eczema Area and Severity Index or the Scoring AD, but recognize these are challenging,” and can be difficult to use if not well trained to use them, he said. “At the very least, do an Investigator’s Global Assessment and do a body surface area measurement.”
In his opinion, four key signs that should be assessed in clinical trials are erythema, edema/papulation, excoriation, and lichenification/prurigo nodules.
Burden of disease
In terms of assessing AD disease burden, guidelines from the American Academy of Dermatology don’t give a specific tool to use, but recommend asking open-ended questions, Dr. Silverberg said. “I would not recommend that, because when you ask an open-ended question, the flood gates open up because most patients are suffering miserably with this disease when it’s uncontrolled.
“That’s why it’s valuable to use structured, validated tools like the Dermatology Life Quality Index and the Patient Reported Outcome Measurement Information System. They don’t take a lot of time to complete, and you can look at the score and determine how burdensome their disease is, even in a busy clinical practice. They’re not going to slow you down; they’re going to speed you up and make you better at your therapeutic decision-making. I can guarantee you that most patients will love you for it. Sometimes patients say to me, ‘you’re the first doctor to ask these questions.’ ”
Extent of disease
Finally, for the extent of disease component of DESCRIBE-AD, he emphasized the importance of doing a full-body exam to appreciate the affected body surface area, flexural versus extensor distribution, and involvement and severity of disease on special sites such as the face, hands, feet, genitals, and scalp.
Dr. Silverberg reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies. He is also a speaker for Regeneron and Sanofi and has received a grant from Galderma.