Clinicians who struggle to get dupilumab approved for their patients with moderate to severe atopic dermatitis (AD) are not alone.
This scenario was illustrated in a 2020 retrospective study of 179 adults with AD who were cared for at the University of Pittsburgh Medical Center, which found that 37% did not start dupilumab, mainly due to insurance denial (19%) and high copay (11%).
"We've all seen this in our practice," Amy S. Paller, MD, said during the Revolutionizing Atopic Dermatitis symposium. "We've also seen the denials until we get step therapy in there, so if I have a child whom I want to treat with dupilumab for safety reasons, I don't like being told that I'm going to have to use cyclosporine or methotrexate or a medication that I think may have higher risks and certainly [would] require blood monitoring — yet that's the state for some patients."
Dupilumab, an interleukin-4 receptor alpha antagonist, is approved for treatment of moderate to severe AD in patients ages 6 and older.
When working to obtain insurance approval of dupilumab, Paller reminded dermatologists to document that the patient has moderate to severe AD "and document the negative effect on quality of life in order to try to help make it easier to get these medications for our patients."
Starting Patients on Dupilumab
Paller, the Walter J. Hamlin Chair and Professor of Dermatology at Northwestern University, Chicago, said that if patients are on another systemic medication prior to starting dupilumab, she allows a transition period of 1-2 months. "Don't just stop that drug because it's ‘not working,' " she said. "I usually do a full dose for the first month, and a half dose for the next month before starting dupilumab. Also, don't stop the use of topical corticosteroids. They can increase treatment response by 10%-20%, even when patients are on dupilumab."
She recommends a 3- to 4-month trial of dupilumab while monitoring changes in disease severity, itch, and quality of life. "Usually there's evidence of early improvement by 2 months in those who are going to do well enough to stay on the drug by about 4 months out," she said. "In my experience, most pediatric patients do very well. In those with an inadequate response, about 50% will do better if you can increase the dose or frequency. Flares can still occur in those who do well. I usually push topicals when that happens."
If patients respond well after starting dupilumab, Paller recommends that they continue on the drug for at least a year before considering a taper with the hope of "resetting" the immune system and having sustained improvement off drug. "Some parents and patients don't want to stop the drug," but for those who do, she tells them that she does not want to abruptly stop treatment, but to "space out the dosing" instead. "If someone is pretty much clear with the medication and is able to continue with topicals as you dial down, that's great. But don't even think about taking them off if somebody's not clear or virtually clear, particularly if they start to flare with lower frequency."
Data on Effectiveness
Real-world data suggest that the effectiveness of dupilumab is similar to the efficacy seen in clinical trials. For example, a recently published systematic review and meta-analysis of 3,303 AD patients on dupilumab found that after 16 weeks of therapy, 60% achieved a 75% improvement in the Eczema Area and Severity (EASI75) score, and 27% achieved an EASI90. In a Dutch study of 210 adults treated with dupilumab for 52 weeks, enrolled in a Dutch registry, the mean percent reduction in EASI score was 70% at 16 weeks and 76.6% by 52 weeks.
In addition, there was at least a 4-point improvement in the Patient-Oriented Eczema Measure (POEM) score and at least a 4-point improvement in the Itch Numeric Rating Scale (NRS), said Paller, who was not involved in the study. "These patient-reported improvements were seen very early on," she noted.
What about drug survival at 1 year? In a retrospective cohort study that drew from insurance databases, 1,963 adults given dupilumab were studied for a mean of 315 days. The rate of persistence was 92% at 6 months and 77% at 12 months. "That means that it's still effective," Paller said.
While that is a short period of time, she compared these results with long-term survival of nonsteroid systemic immunosuppressants such as cyclosporine, referring to a study of adults with AD treated with systemic immunosuppressants, which found "a 32% persistence rate at 12 months in drugs that require more monitoring, so more burden."
Paller disclosed that she is a consultant to and/or an investigator for dupilumab (Dupixent) manufacturers Regeneron and Sanofi, AbbVie, Arena, Bausch, Bristol-Myers Squibb, Dermavant, Eli Lilly, Incyte, Forte, LEO Pharma, LifeMax, Pfizer, and RAPT Therapeutics.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.
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Cite this: Expert Shares Practical Considerations for Dupilumab Treatment - Medscape - Jul 01, 2021.