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To assess the efficacy, safety, immunogenicity, and pharmacokinetics through 240 weeks of ustekinumab treatment in paediatric patients from the long-term extension (LTE) of the phase 1, double-blind UniStar trial. Paediatric patients with moderately to severely active Crohn's disease (CD) were randomised 1:1 and stratified by body weight (<40 or =40?kg) to low- or high-dose intravenous ustekinumab followed by a subcutaneous maintenance dose at Week 8. At Week 16, patients were eligible to enter the LTE at the discretion of the investigator and continued maintenance dosing every 8 weeks up to Week 240. Of the 34 patients who entered the LTE, 25 patients with evaluable data completed Week 48, and 41.2% (14/34) achieved clinical remission at Week 48. Among the 24 patients with Week-0 C-reactive protein (CRP) levels =3?mg/L, 29.2% (7/24) achieved normalisation of CRP at Week 48, while imputing missing data as failures. Through Week 240, the most common adverse events were infections (n?=?28) and gastrointestinal disorders (n?=?26). The most common serious adverse event was worsening of CD (n?=?6). Only one patient had detectable antibodies to ustekinumab. Median serum ustekinumab concentrations remained consistent through Week 48, were detectable through Week 224, and trended lower in patients <40?kg. Efficacy and pharmacokinetics through 1 year and safety and immunogenicity through 4 years of ustekinumab treatment in paediatric patients with CD were generally comparable to those previously reported in adults. The UniStar 16-week induction study reported ustekinumab concentrations in paediatric patients with Crohn's disease (CD) and body weight =40?kg were comparable to adults with CD; patients <40?kg may require a different dosing regimen.Efficacy, pharmacokinetics (PK), safety, and immunogenicity of ustekinumab were similar between paediatric and adults with CD. The UniStar 16-week induction study reported ustekinumab concentrations in paediatric patients with Crohn's disease (CD) and body weight =40?kg were comparable to adults with CD; patients <40?kg may require a different dosing regimen. Efficacy, pharmacokinetics (PK), safety, and immunogenicity of ustekinumab were similar between paediatric and adults with CD. In the long-term UniStar extension, 41.2% (14/34) of patients who continued ustekinumab maintained remission at Week 48.Efficacy and PK through 1 year in ustekinumab-treated paediatric patients were comparable to those previously reported in adults. No new safety or immunogenicity signals were reported through 4 years of ustekinumab treatment. In the long-term UniStar extension, 41.2% (14/34) of patients who continued ustekinumab maintained remission at Week 48. Efficacy and PK through 1 year in ustekinumab-treated paediatric patients were comparable to those previously reported in adults. No new safety or immunogenicity signals were reported through 4 years of ustekinumab treatment. The UniStar long-term extension study of ustekinumab in paediatric patients with moderately to severely active Crohn's disease.

The objective of this study was to estimate longitudinal changes in disease progression (measured by Alzheimer's disease assessment scale-cognitive 11-item [ADAS-cog/11] scale) after bapineuzumab treatment and to identify covariates (demographics or baseline characteristics) contributing to the variability in disease progression rate and baseline disease status.

Disability assessment for dementia (DAD) measurements from two phase-3 studies of bapineuzumab in APOEε4 noncarrier and carrier Alzheimer's disease (AD) patients were integrated to develop a disease progression model.