How Dupixent Improves Moderate-to-Severe AD in Adult and Pediatric Patients

To end an informative first day of dermatology sessions, Sanofi and Regeneron Pharmaceuticals’ representative, Cynthia J. Trickett, physician assistant (PA) in North Dallas, Texas, adjunct faculty member at the University of Texas Southwestern and University of North Texas, and vice chair of the Dermatology PA Foundation, presented treatment results for adult and pediatric patients with moderate-to-severe atopic dermatitis (AD). Most recently, dupilumab (Dupixent; Sanofi and Regeneron Pharmaceuticals, Inc) was approved by the US Food and Drug Administration (FDA) to treat AD patients 6 months and up.¹

The FDA approved dupilumab for children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis on June 7, 2022.² Trickett began her presentation by discussing the importance of considering each patient’s quality of life in the event that topical steroids are ineffective, and the patient’s itch is out of control.¹

“They may come on a day where it’s not flared, and 2 months ago they were just in the worst flare of their life, so please make sure you get the full picture of what their disease is doing in the past 12 months to 24 months,” said Trickett.

The FDA approval of dupilumab to treat AD patients down to 6 months is groundbreaking for dermatologists and patients because^1,2:

1. Dupixent is the first and only biologic approved to treat uncontrolled moderate-to-severe AD from infancy (6 months) to adulthood
2. Patients experienced rapid itch relief at Week 2
3. Adult patients sustained skin clearance at 1 year in adults
4. Dupixent is not an immunosuppressant or steroid
5. There is no requirement for initial lab testing or monitoring

Trickett goes on to explain that this approval is also more reassuring for adult AD patients that have not been prescribed dupilumab yet. If it is safe for an infant down to 6 months to receive treatment, then older pediatric patients or adults can also feel a sense of comfort in the safety and efficacy of the biologic. An estimated 253,000 patients with uncontrolled moderate-to-severe AD have filled at least 1 dupilumab prescription to date as it continues to change the way dermatologists treat their AD patients.

AD is recognized as a chronic, systemic, immune-mediated type 2 inflammatory disease characterized by skin lesions and pruritus. The lesions can present differently on the body depending on the patient's age. For infants, lesions typically appear on their face, scalp, neck, trunk, and extensor surfaces. Lesions can appear on children as polymorphous manifestations, particularly in flexural folds. Lesions on adults also appear as polymorphous manifestations in flexural folds, but also on the hands.¹ Patients describe lesions as chronically recurring, itchy, and a persistent burden.¹

Continuing with the theme of quality of life, Trickett stated that 2.6 million patients (age > 6 months) have uncontrolled moderate-to-severe AD, even despite treatment.¹ Results of a survey asking over 2,000 participants about their disease, patients with moderate-to-severe AD 2 years and older living with flares reported experiencing flareups 136 days per year. Even in remission, 50% of the survey participants expressed they worry about their next flare-up. Trickett explains that there is so much guilt associated with AD and the patient’s caregivers. Many caregivers wonder if they made the bath water just a little too hot for the AD patient, or they should not have had a specific food.

To date, 6 pivotal clinical trials have been conducted with more than 2,800 AD patients.² Many of the patients in the clinical study had a history of comorbidities, with 68% of pediatric patients (6 months to 5 years) reporting having food allergies. Results from the clinical studies include:

• 39% of adult patients reached clear or almost clear at Week 16 compared to 12% of the placebo group,
• 28% of pediatric patients (6 months to 5 years) reached clear or almost clear at Week 16 compared to 4% of the placebo group,
• 24% of pediatric patients (12 to17 years) reached clear or almost clear at Week 16 compared to 2% of the placebo group,
• 68% improvement in itch from baseline for adults and adolescents treated with Dupixent at 18 months.

Dupilumab has no boxed warning, it is not metabolized through the liver or excreted through the kidneys, there are no known drug-to-drug interactions, and live vaccines should be avoided immediately prior to and while receiving dupilumab, said Trickett. She ended her presentation by urging dermatologists to use Dupixent’s support programs to assist their patients through the tedious insurance processes.

References

1. Trickett C. A treatment option for patients with uncontrolled moderate-to-severe atopic dermatitis. Presented at: Maui Derm NP+PA 2022 Summer Conference. June 23-25, 2022. Colorado Springs, Colorado.
2. FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis - Sanofi. Accessed June 29, 2022. https://www.sanofi.com/en/media-room/press-releases/2022/2022-06-07-20-45-00-2458243