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5|25: Celebrating Five Years of Autism Science Day 22: Combined Therapies Hold Promise for More Effective Treatments

February 22, 2010 Leave a comment

In honor of the anniversary of Autism Speaks’ founding on Feb 25, for the next 25 days we will be sharing stories about the many significant scientific advances that have occurred during our first five years together. Our 22nd item, Combined Therapies Hold Promise for More Effective Treatments, is from Autism Speaks’ Top 10 Autism Research Events of 2009..

Just over three years ago the FDA’s landmark approval of risperidone for the treatment of ASD represented a significant breakthrough for the autism community. Since then other large-scale autism studies have sought FDA approval for drugs that target core or associated symptoms for autism, but unfortunately few of these trials have proven successful. In 2009, taking a cue from other disorders such as ADHD where a combined effect of both medication and behavioral therapies has proven fruitful, researchers published the first successful combined randomized controlled trial for ASD. The paper in the Journal of the American Academy of Child and Adolescent Psychiatry demonstrated that combined pharmacological and behavioral treatments was more effective than pharmacological treatment alone for reducing challenging behaviors.

Risperidone is approved for reducing aggression and irritability in children and adolescents with autism. However, its use still presents a number of challenges to clinicians. Like other atypical anti-psychotics it can have adverse side effects including weight gain, potentially leading to increased risk for obesity, and GI symptoms such as diarrhea and constipation, which can already be problematic for children with ASD. Clinicians must therefore balance the benefit of treating the problem behaviors with the potential for creating new health challenges for the child. On the other hand, behavioral therapies have been shown to be one of the most reliably effective treatments for improving problem behaviors with limited side effects. Combination therapies create a synergistic therapeutic environment in which medication allows a child to get more from behavioral therapies and, at the same time, the benefits of behavioral therapy may mean lower doses of medication are required.

A new multi-site study by the Research Units on Pediatric Psychopharmacology Autism Network, the same group that conducted the pivotal studies leading to the approval of risperidone, investigated whether combining risperidone treatments with a simultaneous behavioral intervention would be more effective than medication alone. Their 24-week study of 124 children ages 4-13, compared a treatment regime of risperidone alone with a combined treatment regimen of risperidone and a parent training program that followed the principles of applied behavioral analysis. While both the combined and medication-only treatments reduced the severity of non-compliant behaviors, the combined therapy resulted in a significantly greater reduction while using lower doses of risperidone. The combined therapy was also better at reducing other challenging behaviors, such as irritability and hyperactivity.

This study provides hope for a wider range of available treatments and greater flexibility for clinicians who should be encouraged to use combined approaches in cases where medications or behavioral interventions are not effective on their own. Confirming the effectiveness of coordinated treatments that take full advantage of the benefits of both pharmaceutical and behavioral approaches also demonstrates the continued need to support research establishing the most effective treatments in all realms. Finally, the vast majority of clinical trials conducted to date have only addressed how an individual treatment compares to a placebo. Very few studies have been conducted that make head-to-head comparisons of two or more treatments as was done here, so the success of this trial will also serve to highlight the utility of “comparative effectiveness trials” for determining the best treatments for ASD.

Did you know?: Autism Speaks’ funded Interactive Autism Network (IAN) is a web-based family registry and social network that brings together thousands of families with autism research and provides a forum for families to report information about their experiences.  In a recent study on over 5000 children in IAN, 35% of parents reported that their children were taking at least one psychotropic medicine and the use of these drugs increased with age.  The incidence of a comorbid condition such as seizures, ADHD or anxiety increased the likelihood of medication use.  The IAN authors also reported on correlations between insurance access and use of multiple medications, noting that those children using public insurance plans (such as Medicaid) tended to be on more medications, possibly due to an inability to get coverage for behavioral therapies.

5|25: Celebrating Five Years of Autism Science Day 6: FDA Approval of Risperidone

February 6, 2010 Leave a comment

In honor of the anniversary of Autism Speaks’ founding on Feb 25, for the next 25 days we will be sharing stories about the many significant scientific advances that have occurred during our first five years together. Our sixth item, FDA Approval of Risperidone, is from Autism Speaks’ Top 10 Autism Research Events of 2007.

In late 2006 the U.S. Food and Drug Administration (FDA) approved the first medication indicated to treat certain symptoms associated with autism, making 2007 the first year an approved drug for autism was available. The drug, risperidone sold under the brand name Risperdal, is manufactured and marketed by Janssen, L.P., a subsidiary of Johnson & Johnson.

First introduced in 1993 as an atypical antipsychotic to treat schizophrenia, Risperdal can now be marketed as a treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years. This includes symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums and quickly changing moods. Importantly, Risperdal does not treat the core symptoms of autism such as communication problems and trouble with social interactions. However, J&J used two clinical trials to demonstrate the benefits of the drug in treating the associated behavioral disturbances that can interfere with school, learning and family life.

This event not only sets precedence for gaining FDA approval for medications that treat autistic symptoms, it also shows that autism is considered a viable market for the pharmaceutical industry which will hopefully lead to the development of new compounds that will benefit the quality of life for those living with autism.

Update since this story was first run: On November 20, 2009 the FDA approved Abilify (aripiprazole) for the treatment of irritability associated with autism, making it the second medication to receive an autism indication. Specifically, the drug is approved for children 6-17 to help alleviate symptoms of “aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.” Aripiprazole, which is manufactured and marketed as Abilify by Bristol-Myers Squibb, is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder and depression. Although an FDA approval for a medication addressing the core symptoms of autism is still lacking, the approval of Abilify will offer additional options for families and clinicians.

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