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An institution's review of prescriptions in the first year since dupilumab's historic FDA approval for eosinopihlic esophagitis shows patients waited a mean 46 days to initiate the biologic therapy.
In the first year since its approval by the US Food and Drug Administration (FDA), treatment strategies with dupilumab (Dupixent) for the treatment of eosinophilic esophagitis (EoE) has been characterized by difficulties to achieve timely care delivery, with clinicians preferred the biologic for patients not responding or not adhering to topical corticosteroids (TCS), according to new research from a pediatric tertiary center.1
A new study from a team of US investigators, presented in an abstract at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) 2023 Annual Meeting in San Diego this week—elucidated the real-world application of dupilumab in the first year since being approved by the FDA as the first treatment indicated for EoE. The team found prescribing practices with the new agent have been challenging for pediatric patients with EoE, though a majority of successfully delivered prescriptions involved clinicians using dupilumab in response to poor outcomes or adherence to corticosteroids, or for the drug’ comprehensive benefit for atopic disease treatment.
Led by Nathalie Nguyen, MD, associate professor of pediatrics at the Children’s Hospital Colorado, investigators sought to report on the unique prescribing practices, and perspectives of patients and clinicians, of dupilumab for children with EoE. Approved by the FDA in May 2022 for adult and pediatric patients ≥12 years old, dupilumab was not only the first drug to be indicated for the chronic, inflammatory allergic disease—it was the first biologic therapy to show late-stage clinical trial efficacy in treating EoE.2
“A phase 3 clinical trial demonstrated 60% of patients with EoE had clinicohistopathologic improvement with weekly dupilumab compared to placebo, thus supporting its approval by the FDA,” investigators wrote. “While expert opinion was published to guide clinicians on dupilumab’s use, no reports describe its use in the outpatient setting.”
Nguyen and colleagues conducted their analysis at a pediatric tertiary care referral center at which patients with EoE received multidisciplinary care from specialists, as well as at a gastrointestinal disease clinic. Their assessment correlated with the immediate time period after dupilumab’s approval, May 21, 2022 - May 20, 2023.
Pediatric patients with EoE prescribed dupilumab were prompted with a questionnaire including rational for initiating the therapy, as well as the Self-Report Behavioral Automaticity Index (SRBAI)—the latter of which is designed to interpret the habit strength of a specific behavior on a scale from 1 (indicating no habit) to 7 (indicating a strong habit). Patients completed the SRBAI in reference to their TCS use.
Investigators additionally assessed patients’ demographic data and their insurance status, as well as physicians’ rational for prescribing dupilumab, and the time of initiated care.
The team reported that at the care facility in the 12 months immediately proceeding its FDA approval, dupilumab was prescribed to 42 pediatric patients with EoE. All patients received insurance approval for the indication; mean patient age was 15.6 years old (range, 12 - 21).
Additionally, all but 1 patient (98%) required a Prior Authorization for the treatment; another 17% required a Letter of Appeal. A majority of patients (57%) carried private insurance, and 38% were insured by Medicaid.
Regarding physician rationale for treatment, investigators reported that 52% of patients were prescribed dupilumab primarily due to non-response to TCS; another 28% were due to non-adherence to the treatment, and 10% experienced adverse events. Another 5% were primarily prescribed the biologic to help treat multiple atopic diseases in patients beyond EoE, including asthma or atopic dermatitis. A majority of patients (54%) were prescribed dupilumab for ≥1 reason.
More than two-thirds (69%) of patients were prescribed dupilumab primarily through a multidisciplinary EoE program, 24% were prescribed by gastroenterology and 7% were prescribed through an allergy clinic.
Regarding dosage, the 300 mg once-weekly regimen was by far the most popular strategy by prescribers (93%). Mean time from dupilumab prescription to initiation was 46 days (range, 5 - 154).
From the perspective of 15 patients who completed the questionnaire, mean SRBAI score for TCS adherence was 3.4—indicating a moderate strength of habit. A majority of patients had previously tried multiple therapies to treat their EoE, including an inhaler (80%) proton pump inhibitor (73%), budesonide slurry (67%) and diet therapy (67%).
“Physicians are prescribing dupilumab primarily for non-response to TCS and non-adherence,” investigators concluded. “All require prior authorization with a long delay between prescription initiation and start time.”