Abatacept
Abatacept is indicated for rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis.
Source:
EMA
Active Ingredients:
Indications
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex differences in posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
28.8-29.4%
70.6-71.2%
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex differences in data
No sex-specific dose adjustment is recommended; gender did not affect abatacept clearance after correction for body weight.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Uncommon female-specific adverse reactions included amenorrhea and menorrhagia.
Pregnancy / lactation
N / A
Abatacept should not be used during pregnancy unless the woman’s clinical condition requires treatment. Women of childbearing potential should use effective contraception during treatment and for 14 weeks after the last dose. Abatacept may cross the placenta; infants exposed in utero may be at increased risk of infection, and live vaccines are not recommended for 14 weeks after the mother’s last exposure during pregnancy. It is unknown whether abatacept is excreted in human milk; breast-feeding should be discontinued during treatment and for up to 14 weeks after the last dose.
Sex-specific non-clinical findings
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on male fertility.
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on female fertility.
Disease prevalence by sex
Men
28.8-29.4%
Women
70.6-71.2%
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex differences in data
No sex-specific dose adjustment is recommended; gender did not affect abatacept clearance after correction for body weight.
Sex-specific differences in possible side effects
No sex-specific data
Men
No sex-specific data were reported in the evaluated sources.
Women
Uncommon female-specific adverse reactions included amenorrhea and menorrhagia.
Pregnancy / lactation
Men
N / A
Women
Abatacept should not be used during pregnancy unless the woman’s clinical condition requires treatment. Women of childbearing potential should use effective contraception during treatment and for 14 weeks after the last dose. Abatacept may cross the placenta; infants exposed in utero may be at increased risk of infection, and live vaccines are not recommended for 14 weeks after the mother’s last exposure during pregnancy. It is unknown whether abatacept is excreted in human milk; breast-feeding should be discontinued during treatment and for up to 14 weeks after the last dose.
Sex-specific non-clinical findings
Men
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on male fertility.
Women
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on female fertility.
General information
General Efficacy
Primary endpoints: Primary efficacy measures across pivotal trials included ACR20-based response and disease-activity change in rheumatoid arthritis, the proportion of patients achieving ACR20 at Week 24 in psoriatic arthritis, and time to disease flare in the pJIA withdrawal study. In RA, key primary endpoints included mean change in disease activity at 6 months and non-inferiority of ACR20 at 12 months in SC-II. Secondary endpoints: Important supportive endpoints included ACR50 and ACR70 responses, DAS28 remission and disease-activity assessments, radiographic or MRI structural damage progression, HAQ-DI physical function, SF-36 quality of life, PASI skin responses in psoriatic arthritis, and ACR Pedi/ACRP response levels plus inactive disease in pJIA.
General Posology
Dose depends on formulation, indication, age, and body weight. Intravenous adult RA and PsA: 30-minute IV infusion at about 10 mg/kg, using 500 mg if body weight is under 60 kg, 750 mg if 60 to 100 kg, and 1,000 mg if over 100 kg; give at baseline, then at weeks 2 and 4, then every 4 weeks. Subcutaneous adult RA: 125 mg weekly regardless of weight, with or without a single IV loading dose; if used, give the first 125 mg SC dose within a day of the IV infusion, then continue weekly. Subcutaneous adult PsA: 125 mg weekly without IV loading. pJIA IV: ages 6 to 17 years, 10 mg/kg if under 75 kg; if 75 kg or more, use the adult IV regimen, not exceeding 1,000 mg; give at baseline, weeks 2 and 4, then every 4 weeks. pJIA SC pre-filled syringe: ages 2 to 17 years, weekly weight-based dosing of 50 mg for 10 to less than 25 kg, 87.5 mg for 25 to less than 50 kg, and 125 mg for 50 kg or more, without an IV loading dose.
Further Dose Adjustments
Contraindicated in patients with hypersensitivity to abatacept or any excipient and in those with severe and uncontrolled infections such as sepsis or opportunistic infections.
Possible Side Effects
Very common adverse reactions were upper respiratory tract infection, including tracheitis, nasopharyngitis, and sinusitis. Frequently reported adverse reactions at 5% or more also included headache and nausea. Serious adverse reactions included serious infections such as sepsis and pneumonia. Discontinuation due to adverse reactions occurred in 3.0% of abatacept-treated patients, and discontinuation due to acute infusion-related reactions occurred in 0.3% of IV-treated patients.
Contraindications
Hypersensitivity to the active substance or any excipient, and severe and uncontrolled infections such as sepsis and opportunistic infections.
Clinical Trial Type and Population
Abatacept was evaluated in randomised, double-blind, placebo-controlled studies in adults with active rheumatoid arthritis, adults with active psoriatic arthritis, and paediatric patients with polyarticular juvenile idiopathic arthritis. Major trials were RA Studies I (n=339), II (n=638), III (n=389), IV (n=1441), V (n=431), VI (n=509), SC-I (n=1371), SC-II (n=646), and SC-III (n=351); PsA-I (n=170) and PsA-II (n=424) in adults aged 18 years and older; and pJIA IV (n=190, mean age 12.4 years) and pJIA SC (n=219 across ages 2 to 17 years, mean age 10.6 years). The document reports sample sizes and paediatric mean ages, but not the percentage of women/girls in the pivotal trials.
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex differences in posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
28.8-29.4%
70.6-71.2%
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex differences in data
No sex-specific dose adjustment is recommended; gender did not affect abatacept clearance after correction for body weight.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Uncommon female-specific adverse reactions included amenorrhea and menorrhagia.
Pregnancy / lactation
N / A
Abatacept should not be used during pregnancy unless the woman’s clinical condition requires treatment. Women of childbearing potential should use effective contraception during treatment and for 14 weeks after the last dose. Abatacept may cross the placenta; infants exposed in utero may be at increased risk of infection, and live vaccines are not recommended for 14 weeks after the mother’s last exposure during pregnancy. It is unknown whether abatacept is excreted in human milk; breast-feeding should be discontinued during treatment and for up to 14 weeks after the last dose.
Sex-specific non-clinical findings
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on male fertility.
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on female fertility.
Disease prevalence by sex
Men
28.8-29.4%
Women
70.6-71.2%
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex differences in data
No sex-specific dose adjustment is recommended; gender did not affect abatacept clearance after correction for body weight.
Sex-specific differences in possible side effects
No sex-specific data
Men
No sex-specific data were reported in the evaluated sources.
Women
Uncommon female-specific adverse reactions included amenorrhea and menorrhagia.
Pregnancy / lactation
Men
N / A
Women
Abatacept should not be used during pregnancy unless the woman’s clinical condition requires treatment. Women of childbearing potential should use effective contraception during treatment and for 14 weeks after the last dose. Abatacept may cross the placenta; infants exposed in utero may be at increased risk of infection, and live vaccines are not recommended for 14 weeks after the mother’s last exposure during pregnancy. It is unknown whether abatacept is excreted in human milk; breast-feeding should be discontinued during treatment and for up to 14 weeks after the last dose.
Sex-specific non-clinical findings
Men
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on male fertility.
Women
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on female fertility.
General information
General Efficacy
Primary endpoints: Primary efficacy measures across pivotal trials included ACR20-based response and disease-activity change in rheumatoid arthritis, the proportion of patients achieving ACR20 at Week 24 in psoriatic arthritis, and time to disease flare in the pJIA withdrawal study. In RA, key primary endpoints included mean change in disease activity at 6 months and non-inferiority of ACR20 at 12 months in SC-II. Secondary endpoints: Important supportive endpoints included ACR50 and ACR70 responses, DAS28 remission and disease-activity assessments, radiographic or MRI structural damage progression, HAQ-DI physical function, SF-36 quality of life, PASI skin responses in psoriatic arthritis, and ACR Pedi/ACRP response levels plus inactive disease in pJIA.
General Posology
Dose depends on formulation, indication, age, and body weight. Intravenous adult RA and PsA: 30-minute IV infusion at about 10 mg/kg, using 500 mg if body weight is under 60 kg, 750 mg if 60 to 100 kg, and 1,000 mg if over 100 kg; give at baseline, then at weeks 2 and 4, then every 4 weeks. Subcutaneous adult RA: 125 mg weekly regardless of weight, with or without a single IV loading dose; if used, give the first 125 mg SC dose within a day of the IV infusion, then continue weekly. Subcutaneous adult PsA: 125 mg weekly without IV loading. pJIA IV: ages 6 to 17 years, 10 mg/kg if under 75 kg; if 75 kg or more, use the adult IV regimen, not exceeding 1,000 mg; give at baseline, weeks 2 and 4, then every 4 weeks. pJIA SC pre-filled syringe: ages 2 to 17 years, weekly weight-based dosing of 50 mg for 10 to less than 25 kg, 87.5 mg for 25 to less than 50 kg, and 125 mg for 50 kg or more, without an IV loading dose.
Further Dose Adjustments
Contraindicated in patients with hypersensitivity to abatacept or any excipient and in those with severe and uncontrolled infections such as sepsis or opportunistic infections.
Possible Side Effects
Very common adverse reactions were upper respiratory tract infection, including tracheitis, nasopharyngitis, and sinusitis. Frequently reported adverse reactions at 5% or more also included headache and nausea. Serious adverse reactions included serious infections such as sepsis and pneumonia. Discontinuation due to adverse reactions occurred in 3.0% of abatacept-treated patients, and discontinuation due to acute infusion-related reactions occurred in 0.3% of IV-treated patients.
Contraindications
Hypersensitivity to the active substance or any excipient, and severe and uncontrolled infections such as sepsis and opportunistic infections.
Clinical Trial Type and Population
Abatacept was evaluated in randomised, double-blind, placebo-controlled studies in adults with active rheumatoid arthritis, adults with active psoriatic arthritis, and paediatric patients with polyarticular juvenile idiopathic arthritis. Major trials were RA Studies I (n=339), II (n=638), III (n=389), IV (n=1441), V (n=431), VI (n=509), SC-I (n=1371), SC-II (n=646), and SC-III (n=351); PsA-I (n=170) and PsA-II (n=424) in adults aged 18 years and older; and pJIA IV (n=190, mean age 12.4 years) and pJIA SC (n=219 across ages 2 to 17 years, mean age 10.6 years). The document reports sample sizes and paediatric mean ages, but not the percentage of women/girls in the pivotal trials.
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex differences in posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
Not reported in available sources.
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex differences in data
No sex-specific dose adjustment is recommended; gender did not affect abatacept clearance after correction for body weight.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Uncommon female-specific adverse reactions included amenorrhea and menorrhagia.
Pregnancy / lactation
N / A
Abatacept should not be used during pregnancy unless the woman’s clinical condition requires treatment. Women of childbearing potential should use effective contraception during treatment and for 14 weeks after the last dose. Abatacept may cross the placenta; infants exposed in utero may be at increased risk of infection, and live vaccines are not recommended for 14 weeks after the mother’s last exposure during pregnancy. It is unknown whether abatacept is excreted in human milk; breast-feeding should be discontinued during treatment and for up to 14 weeks after the last dose.
Sex-specific non-clinical findings
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on male fertility.
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on female fertility.
Disease prevalence by sex
Not reported in available sources.
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex differences in data
No sex-specific dose adjustment is recommended; gender did not affect abatacept clearance after correction for body weight.
Sex-specific differences in possible side effects
No sex-specific data
Men
No sex-specific data were reported in the evaluated sources.
Women
Uncommon female-specific adverse reactions included amenorrhea and menorrhagia.
Pregnancy / lactation
Men
N / A
Women
Abatacept should not be used during pregnancy unless the woman’s clinical condition requires treatment. Women of childbearing potential should use effective contraception during treatment and for 14 weeks after the last dose. Abatacept may cross the placenta; infants exposed in utero may be at increased risk of infection, and live vaccines are not recommended for 14 weeks after the mother’s last exposure during pregnancy. It is unknown whether abatacept is excreted in human milk; breast-feeding should be discontinued during treatment and for up to 14 weeks after the last dose.
Sex-specific non-clinical findings
Men
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on male fertility.
Women
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on female fertility.
General information
General Efficacy
Primary endpoints: Primary efficacy measures across pivotal trials included ACR20-based response and disease-activity change in rheumatoid arthritis, the proportion of patients achieving ACR20 at Week 24 in psoriatic arthritis, and time to disease flare in the pJIA withdrawal study. In RA, key primary endpoints included mean change in disease activity at 6 months and non-inferiority of ACR20 at 12 months in SC-II. Secondary endpoints: Important supportive endpoints included ACR50 and ACR70 responses, DAS28 remission and disease-activity assessments, radiographic or MRI structural damage progression, HAQ-DI physical function, SF-36 quality of life, PASI skin responses in psoriatic arthritis, and ACR Pedi/ACRP response levels plus inactive disease in pJIA.
General Posology
Dose depends on formulation, indication, age, and body weight. Intravenous adult RA and PsA: 30-minute IV infusion at about 10 mg/kg, using 500 mg if body weight is under 60 kg, 750 mg if 60 to 100 kg, and 1,000 mg if over 100 kg; give at baseline, then at weeks 2 and 4, then every 4 weeks. Subcutaneous adult RA: 125 mg weekly regardless of weight, with or without a single IV loading dose; if used, give the first 125 mg SC dose within a day of the IV infusion, then continue weekly. Subcutaneous adult PsA: 125 mg weekly without IV loading. pJIA IV: ages 6 to 17 years, 10 mg/kg if under 75 kg; if 75 kg or more, use the adult IV regimen, not exceeding 1,000 mg; give at baseline, weeks 2 and 4, then every 4 weeks. pJIA SC pre-filled syringe: ages 2 to 17 years, weekly weight-based dosing of 50 mg for 10 to less than 25 kg, 87.5 mg for 25 to less than 50 kg, and 125 mg for 50 kg or more, without an IV loading dose.
Further Dose Adjustments
Contraindicated in patients with hypersensitivity to abatacept or any excipient and in those with severe and uncontrolled infections such as sepsis or opportunistic infections.
Possible Side Effects
Very common adverse reactions were upper respiratory tract infection, including tracheitis, nasopharyngitis, and sinusitis. Frequently reported adverse reactions at 5% or more also included headache and nausea. Serious adverse reactions included serious infections such as sepsis and pneumonia. Discontinuation due to adverse reactions occurred in 3.0% of abatacept-treated patients, and discontinuation due to acute infusion-related reactions occurred in 0.3% of IV-treated patients.
Contraindications
Hypersensitivity to the active substance or any excipient, and severe and uncontrolled infections such as sepsis and opportunistic infections.
Clinical Trial Type and Population
Abatacept was evaluated in randomised, double-blind, placebo-controlled studies in adults with active rheumatoid arthritis, adults with active psoriatic arthritis, and paediatric patients with polyarticular juvenile idiopathic arthritis. Major trials were RA Studies I (n=339), II (n=638), III (n=389), IV (n=1441), V (n=431), VI (n=509), SC-I (n=1371), SC-II (n=646), and SC-III (n=351); PsA-I (n=170) and PsA-II (n=424) in adults aged 18 years and older; and pJIA IV (n=190, mean age 12.4 years) and pJIA SC (n=219 across ages 2 to 17 years, mean age 10.6 years). The document reports sample sizes and paediatric mean ages, but not the percentage of women/girls in the pivotal trials.
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex differences in posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
Not reported in available sources.
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex differences in data
No sex-specific dose adjustment is recommended; gender did not affect abatacept clearance after correction for body weight.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Uncommon female-specific adverse reactions included amenorrhea and menorrhagia.
Pregnancy / lactation
N / A
Abatacept should not be used during pregnancy unless the woman’s clinical condition requires treatment. Women of childbearing potential should use effective contraception during treatment and for 14 weeks after the last dose. Abatacept may cross the placenta; infants exposed in utero may be at increased risk of infection, and live vaccines are not recommended for 14 weeks after the mother’s last exposure during pregnancy. It is unknown whether abatacept is excreted in human milk; breast-feeding should be discontinued during treatment and for up to 14 weeks after the last dose.
Sex-specific non-clinical findings
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on male fertility.
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on female fertility.
Disease prevalence by sex
Not reported in available sources.
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex differences in data
No sex-specific dose adjustment is recommended; gender did not affect abatacept clearance after correction for body weight.
Sex-specific differences in possible side effects
No sex-specific data
Men
No sex-specific data were reported in the evaluated sources.
Women
Uncommon female-specific adverse reactions included amenorrhea and menorrhagia.
Pregnancy / lactation
Men
N / A
Women
Abatacept should not be used during pregnancy unless the woman’s clinical condition requires treatment. Women of childbearing potential should use effective contraception during treatment and for 14 weeks after the last dose. Abatacept may cross the placenta; infants exposed in utero may be at increased risk of infection, and live vaccines are not recommended for 14 weeks after the mother’s last exposure during pregnancy. It is unknown whether abatacept is excreted in human milk; breast-feeding should be discontinued during treatment and for up to 14 weeks after the last dose.
Sex-specific non-clinical findings
Men
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on male fertility.
Women
Population pharmacokinetic analyses indicated no gender effect on clearance after correction for body weight; in rats, abatacept had no undesirable effects on female fertility.
General information
General Efficacy
Primary endpoints: Primary efficacy measures across pivotal trials included ACR20-based response and disease-activity change in rheumatoid arthritis, the proportion of patients achieving ACR20 at Week 24 in psoriatic arthritis, and time to disease flare in the pJIA withdrawal study. In RA, key primary endpoints included mean change in disease activity at 6 months and non-inferiority of ACR20 at 12 months in SC-II. Secondary endpoints: Important supportive endpoints included ACR50 and ACR70 responses, DAS28 remission and disease-activity assessments, radiographic or MRI structural damage progression, HAQ-DI physical function, SF-36 quality of life, PASI skin responses in psoriatic arthritis, and ACR Pedi/ACRP response levels plus inactive disease in pJIA.
General Posology
Dose depends on formulation, indication, age, and body weight. Intravenous adult RA and PsA: 30-minute IV infusion at about 10 mg/kg, using 500 mg if body weight is under 60 kg, 750 mg if 60 to 100 kg, and 1,000 mg if over 100 kg; give at baseline, then at weeks 2 and 4, then every 4 weeks. Subcutaneous adult RA: 125 mg weekly regardless of weight, with or without a single IV loading dose; if used, give the first 125 mg SC dose within a day of the IV infusion, then continue weekly. Subcutaneous adult PsA: 125 mg weekly without IV loading. pJIA IV: ages 6 to 17 years, 10 mg/kg if under 75 kg; if 75 kg or more, use the adult IV regimen, not exceeding 1,000 mg; give at baseline, weeks 2 and 4, then every 4 weeks. pJIA SC pre-filled syringe: ages 2 to 17 years, weekly weight-based dosing of 50 mg for 10 to less than 25 kg, 87.5 mg for 25 to less than 50 kg, and 125 mg for 50 kg or more, without an IV loading dose.
Further Dose Adjustments
Contraindicated in patients with hypersensitivity to abatacept or any excipient and in those with severe and uncontrolled infections such as sepsis or opportunistic infections.
Possible Side Effects
Very common adverse reactions were upper respiratory tract infection, including tracheitis, nasopharyngitis, and sinusitis. Frequently reported adverse reactions at 5% or more also included headache and nausea. Serious adverse reactions included serious infections such as sepsis and pneumonia. Discontinuation due to adverse reactions occurred in 3.0% of abatacept-treated patients, and discontinuation due to acute infusion-related reactions occurred in 0.3% of IV-treated patients.
Contraindications
Hypersensitivity to the active substance or any excipient, and severe and uncontrolled infections such as sepsis and opportunistic infections.
Clinical Trial Type and Population
Abatacept was evaluated in randomised, double-blind, placebo-controlled studies in adults with active rheumatoid arthritis, adults with active psoriatic arthritis, and paediatric patients with polyarticular juvenile idiopathic arthritis. Major trials were RA Studies I (n=339), II (n=638), III (n=389), IV (n=1441), V (n=431), VI (n=509), SC-I (n=1371), SC-II (n=646), and SC-III (n=351); PsA-I (n=170) and PsA-II (n=424) in adults aged 18 years and older; and pJIA IV (n=190, mean age 12.4 years) and pJIA SC (n=219 across ages 2 to 17 years, mean age 10.6 years). The document reports sample sizes and paediatric mean ages, but not the percentage of women/girls in the pivotal trials.
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source
Source:
EMA
Date of first authorisation:
21 May 2007
Source URL:
Prevalence Source: