WASHINGTON -- Children with autism spectrum disorder (ASD) and attention deficit-hyperactivity disorder (ADHD) had improvements in their symptoms with a liquid formulation of methylphenidate (Quillivant), researchers reported here.
In preliminary findings from a small trial, patients given the drug had significant improvement in Clinical Global Impression (CGI) scores after 6 weeks compared with baseline, reported , of Seattle Children's Hospital, and colleagues reported at the American Professional Society of ADHD and Related Disorders (APSARD) meeting.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
"We found the medication was helpful," Stein told 51˶. "There were improvements in overall impressions of symptoms of both ASD and ADHD."
It's well known that many kids with ASD have symptoms of ADHD, especially overactivity, impulsivity, and problems with concentration, Stein said. These children are often treated with stimulant medications, but use of those drugs in this population hasn't been well studied.
Kids also haven't been able to be diagnosed with both conditions simultaneously until recently, Stein said.
"In DSM-IV, if one had autism, one could not have ADHD," Stein said. "But now DSM-5 allows it. It was a diagnostic hierarchy that was changed. It makes sense to separate them and now it's possible to code patients as having both."
That also provided good rationale to study use of stimulants in this population, Stein said. A liquid formulation is especially appealing because these kids are a bit more sensitive to the side effects of stimulants, so a liquid version can be started at a low dose and titrated. Difficulty swallowing pills is also common in this population, so a liquid formulation erases that barrier, he added.
And finally, the extended-release formulation has the potential to mitigate symptoms not only during school hours, but at home as well, Stein said.
For their study, the researchers enrolled 16 children, mean age 9.75 years, with a history of ASD and ADHD, who were recruited from outpatient clinics in the community. Patients were randomized to 6 weeks of either a graduated low-dose titration schedule (5 to 10 mg, mean EOT dose 9.5 mg) or a graduated medium-dose schedule (5 to 20 mg, mean EOT dose 20 mg).
Although Stein said he is hoping to enroll more people, the preliminary results showed a significant decrease in ADHD symptoms and impairment over the 6 weeks of the study.
The mean CGI severity score at 6 weeks was significantly lower than it was at baseline, they found (3.38 versus 4.44, P<0.001).
They also found small but significant improvement in overall social scores as measured by the Social Responsiveness Scale (SRS) at 6 weeks compared with baseline (75.56 versus 80.00, P<0.01).
"Both doses were associated with small improvements [in SRS scores], but they were in the clinical range," Stein said. "We didn't think this medication would cure the social impairments associated with autism, but that improved."
Stein added that the data showed better improvements for patients on the medium dose compared with the lower dose.
He concluded that the drug was very well tolerated, with no unexpected side effects or serious adverse effects. His next steps are to enroll up to six more patients, and to assess pharmacogenetic predictors of response.
Disclosures
Stein disclosed relevant relationships with Pfizer, Shire, Iron Shore Pharmaceuticals, and Alcobra.
Primary Source
American Professional Society of ADHD and Related Disorders
Stein M, et al "Efficacy of Quillivant XR on ADHD in children with autism spectrum disorder (ASD) and ADHD: Preliminary findings" APSARD 2016; Abstract 24.