| Abstrakt: |
Sixty-seven adverse events (AEs) were reported by 20 patients (57.1%) during the OLE study, including 46 AEs by 13 rollover patients (56.5%) and 21 AEs by 7 treatment-naive patients (58.3%). Before the encounter we found that providers should consider the efficacy of TD for each patient, recognize limitations of TD in pediatric populations, collect patient-submitted still photographs of the lesion and area of interest, review clinical history and supplemental images submitted by the patient and/or referring provider, utilize telehealth platforms that ensure confidential, secure communication, and provide the patient with information on how to dress, sit, light, and stage themselves for the best TD outcomes. After the encounter the provider should provide patient with a visit summary via the patient portal, document clinical reasoning and treatment strategies/goals for the referring provider to reference, and provide the patient with clear return-to-clinic indications as well as "red-flags" that should trigger an ED visit, if applicable. A phase 3 study of B-VEC in 31 patients with DEB demonstrated a significant improvement in complete wound healing at 6 months in the B-VEC-treated wounds (67%) vs placebo-treated wounds (22%) and was well tolerated. SP 1 sp Patients from the phase 3 (rollover) and treatment-naive DEB patients were eligible to enroll in the open-label extension (OLE) study. Results: We identified a total of 22 patients diagnosed with KHE from our registry; of those patients 7 did not require any treatment and none of these patients experienced KMP. [Extracted from the article] |
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