Ask consistent questions
One of the lessons in that research is the importance of question specificity.
“If you just walk into a patient’s room, who is on systemic therapy, and ask, ‘How are you feeling? Any problems?’ you may well miss having the person report the nausea that he is experiencing. In contrast, you likely would capture that data if you said, ‘I know you’re on methotrexate. Tell me a little about whether you’ve had any abdominal discomfort or nausea or anything else that has to do with your stomach.’ Then follow that with questions about how soon it occurs after taking the drug and if persistent, allowing the doctor to make a decision about the possible relationship to the nausea to methotrexate,” she says. “The more we can be consistent in our data collection, the more value there is for pooling datasets to understand disease better or to understand the outcome of treatment.”
Without uniformity in questioning and a fairly comprehensive collection of data, it’s difficult to get good data from a retrospective review, she says.
“That’s one of the reasons we think prospective registries would be great,” Dr. Paller says.
While establishing prospective registries can be challenging and costly, Dr. Paller and her colleagues in PeDRA and the International Eczema Council are jointly planning to create uniform minimal datasets for use in clinical practice and incorporation into electronic medical records.
These would include the same questions about history, findings on examination, and planned intervention for children with atopic dermatitis that are important to ask in the caring for the patient. This uniform dataset could be tapped to learn more about disease manifestations and treatment outcomes. If successful, a similar process for documentation could be applied to pediatric psoriasis and other diseases.
Comparing apples to apples offers important insight. For example, in the PeDRA-EPPWG study researchers found big differences in gastrointestinal side effects from methotrexate, depending on whether the patients were in Europe versus North America. European children experienced significantly more gastrointestinal side effects from the medication, despite receiving the same amount of folic acid weekly. The difference was that most European kids were given the folic acid to take once a week on the day after the methotrexate; in contrast, the North American children were largely taking a smaller dose of folic acid daily or on the six days when methotrexate was not being given.
“I can tell you that many of our colleagues in Europe have switched to folic acid on six to seven days a week as a result of this study’s data,” Dr. Paller says.
A key study finding: Worldwide, methotrexate is the most commonly used systemic therapy for pediatric psoriasis. Overall, approximately 70% of the children used methotrexate and 27% used tumor necrosis factor (TNF) inhibitors.
Compared to methotrexate, cyclosporin, acitretin and fumaric acid esters (not used in the U.S.) had more medication-related adverse events, overall, and per patient years. TNF inhibitors had fewer overall medication-related adverse events than methotrexate.
Dr. Paller and colleagues are now analyzing this data to consider differences in efficacy, as well as the differences between Europe versus North America beyond the utilization of folic acid, she says.
“This study was a great example of the power of a research collaborative. And, in this particular case, the power of getting investigators together internationally to ask important questions,” Dr. Paller says.
Disclosures: Dr. Paller reports no relevant disclosures.