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Simponi effectively treats pediatric moderate-to-severe UC
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ORLANDO — Simponi safely and effectively treated moderate-to-severe ulcerative colitis in pediatric patients, according to a poster presented at the Advances in Inflammatory Bowel Disease annual conference.
Researchers enrolled 35 patients aged between 2 and 17 years with moderate-to-severe UC who previously failed treatment with corticosteroids or immunomodulators and were treatment-naive to anti-TNF treatment, and assigned them induction doses of Simponi (golimumab, Janssen) for 14 weeks. Patients who weighed less than 45 kg received 90 mg/m2 at week 0 and 45 mg/m2 at week 2 and patients weighing greater than 45 kg received 200 mg at week 0 and 100 mg at week 2. At 6 weeks, all patients were evaluated and continued treatment through 14 weeks. A study extension was given (14-126 weeks) and is currently ongoing.
The goal was to determine the safety and efficacy of the treatment on a pediatric population and compare it with results from an adult population.
Overall, the mean serum golimumab concentrations in the pediatric population were 6.5 µg/mL at 2 weeks, 6.5 µg/mL at 4 weeks and 2.6 µg/mL at 6 weeks, which was comparable to concentrations of the adult patients (6.4 µg/mL, 5.6 µg/mL and 2.1 µg/mL). In addition, these mean concentrations stayed comparable through 6 weeks among both populations, according to the abstract. At 14 weeks, mean golimumab concentration was 2.1 µg/mL in the pediatric patients, comparable to the adult patients (1.8 µg/mL).
At 6 weeks, 60% of pediatric patients achieved a clinical response and 42.9% achieved clinical remission. Also at 6 weeks, mucosal healing was evident in 54.3% of patients, with 22.9% of patients achieving complete mucosal healing.
“Overall, efficacy outcomes in the golimumab pediatric UC population were consistent with, or numerically greater compared with those observed in the golimumab adult UC population at week 6,” the researchers wrote.
Through 14 weeks, 94.3% of patients reported at least one adverse event and 8.6% had an adverse event that led to discontinuation of the study. Common adverse events were UC (37.1%), abdominal pain (25.7%) and headache (25.7%). Eleven patients reported 13 serious adverse events, including UC flare (n = 10), and one patient each with abdominal pain, iron deficiency anemia or acute pancreatitis.
“The [pharmacokinetics], efficacy and safety outcomes observed in this pediatric UC population were comparable with those previously reported in the golimumab adult population phase 3 trials,” the researchers concluded. – by Melinda Stevens
Reference: Hyams J, et al. Abstract P-. Presented at Advances in Inflammatory Bowel Diseases; Dec. 10-12, 2015; Orlando, Fla.
Disclosures: Healio Gastroenterology was unable to confirm relevant financial disclosures at the time of publication.