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Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval.
The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC.
In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.
The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab.
Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.
Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said.
The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.
Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.
This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC.
Full prescribing information and medication guide is available online.
A version of this article first appeared on Medscape.com.
Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval.
The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC.
In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.
The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab.
Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.
Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said.
The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.
Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.
This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC.
Full prescribing information and medication guide is available online.
A version of this article first appeared on Medscape.com.
Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval.
The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC.
In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.
The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab.
Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.
Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said.
The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.
Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.
This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC.
Full prescribing information and medication guide is available online.
A version of this article first appeared on Medscape.com.