Data presented today at a major medical meeting include findings that demonstrate improved handwriting performance in children with Attention Deficit Hyperactivity Disorder (ADHD) when taking CONCERTA® (OROS® methylphenidate HCl Extended-Release Tablets CII) compared to placebo. This data, which was presented by McNeil Pediatrics™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is one of two sub-analyses presented today on pooled data from two randomized, double-blind, placebo-controlled studies examining CONCERTA® efficacy in patients in simulated classroom environments.
"Previous research suggests handwriting can be a challenge in children with ADHD, who may have impaired handwriting performance compared to children without ADHD" said H. Lynn Starr, M.D., director of Medical Affairs for Ortho-McNeil Janssen Scientific Affairs, L.L.C. "Based on this premise, we wanted to examine CONCERTA® treatment in this area more closely. We hope our efforts may provide insight for parents and healthcare professionals interested in this research."
In this sub-analysis (Poster 5.26), the effect of CONCERTA® on handwriting performance was evaluated in 139 patients with ADHD, ages 9 to 12, in simulated classroom settings that compared patients' handwriting skills when they were treated with CONCERTA® versus when they received placebo. Results showed patients had better handwriting performance on the days when they took CONCERTA® than on the days they took placebo.
Handwriting was assessed using the Test of Handwriting Skills-Revised (THS-R). The THS-R is a standardized assessment designed to evaluate neurosensory integration shown in print and cursive writing. In a review of previously published studies, children with ADHD scored significantly lower than children without ADHD using this measure. In the CONCERTA® sub-analysis presented today, the mean THS-R standard scores showed patients scored 91.46 on the day they took CONCERTA® versus 87.03 on the day they took placebo (p<0.0001).
In a separate sub-analysis of data (Poster 5.27) from the pooled classroom studies, CONCERTA® was compared to placebo using a skill-adjusted math test that measures attention in ADHD, known as the PERMP (Permanent Product Measure of Performance).
In this analysis, all 139 patients ages 9 to 12 had a confirmed diagnosis of ADHD, and 15 patients also had a co-morbid math-based learning disability (LD). The PERMP provided patients a series of math problems during the laboratory school day. The patients' performance on problems attempted and problems correctly answered was used to evaluate the effect of CONCERTA® on attention and focus.
Results of this sub-analysis showed patients with a math LD had higher mean PERMP scores for both the number of math problems attempted (93.8 vs. 67.2, respectively; p<0.01) as well as the number of math problems answered correctly (87.8 vs. 63.0, respectively; p<0.01) following treatment with CONCERTA® compared to placebo. Similarly, patients with no math LD also had higher mean PERMP scores in both measures after treatment with CONCERTA® compared to placebo (114.2 vs. 81.6, respectively; p<0.0001; 109.9 vs. 76.8, respectively; p<0.0001).
Adverse events occurring in 10 percent or more of patients in either sub-analysis presented today were consistent with those previously reported for CONCERTA® and included decreased appetite, upper abdominal pain, headache, irritability and initial insomnia. Two patients discontinued due to adverse events. No serious adverse events or deaths were reported.
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