Abstracts

Rationale: On June 25, 2018, the U.S. Food & Drug Administration approved Epidiolex (cannabidiol) oral solution for patient two years of age or older in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS).  Epidiolex is the first FDA-approved plant-based drug derived from cannabis.  Although no cannabis-based products were approved prior to that time, many patients used non-FDA approved cannabis-based treatments prior to the approval of Epidiolex . A wide-range of treatments, such as hemp oils and medical marijuana have been used, each with different compositions and concentrations. Challenges for treating physicians include the inconsistency and lack of knowledge of the contents of such products.   Thus, upon approval of Epidiolex, many patients transitioned from non-FDA approved cannabis-based treatments to Epidiolex.  We retrospectively reviewed the experience of patients who transitioned from non-FDA approved cannabis products to Epidiolex to evaluate the success of that transition and determine how often these treatments are used in combination Methods: We retrospectively reviewed all pediatric patients prescribed Epidiolex in our center.  A total of 53 prescriptions for Epidiolex were written since its approval in June 2018.  The charts of all of those patients were reviewed to determine which patients had used cannabis-based treatments prior to Epidiolex.  A total of 26 patients were identified as having used a cannabis-based treatment prior to Epidiolex. Demographic  and clinical information from those patients was recorded for analysis. Results: Of the 26 patients who used cannabis-based treatments prior to Epidiolex, 18 carried a diagnosis of LGS, 3 had DS, and 5 patients had intractable epilepsy (without clear features of LGS or DS). A total of 11 patients (40.7 %) continued to use their original cannabis-based treatment in addition to Epidiolex, 12 (44%) fully discontinued the prior cannabis-based therapy, and 3 (14%) did not report their status. The average duration of Epidiolex use for patients who continued to use other cannabis-based treatments was 6.8 months compared to 6.5 months for patients who discontinued non-FDA approved cannabis treatments. Among the 18 patients with a diagnosis of LGS, 8 (44%) discontinued other cannabis-based treatments, compared to 9 (50%) who continued to use them. Among DS patients, all 3 (100%) discontinued their prior cannabis-based treatments after starting Epidiolex. Conclusions: Although Epidiolex is the only FDA approved cannabis product in the United States, a high percentage (49%) of patients in our center were using non-FDA approved cannabis-based therapies prior to initiation of Epidiolex.  Among those patients who were using a non-FDA approved treatment, 40% remained on that treatment even after Epidiolex was started.  A much higher percentage of LGS patients continued to use non-FDA approved cannabis-based treatments than DS patients, although the DS patients were much smaller in number.  This raises a question of whether DS patients have greater success on Epidolex than LGS patients. These findings also indicate the importance inquiring about continued use of non-FDA approved cannabis treatments in patients on Epidiolex, particularly since such therapies may contribute to side-effects.  Further analysis will be needed to determine the reasons patients remain on these treatments and whether they truly offer any additional benefits with regards to seizure control. Funding: No funding