Tremfya and Skyrizi Comparison

Tremfya®(guselkumab)	Skyrizi®(risankizumab)
Prescription Only Tremfya, an interleukin inhibitor, is indicated for the treatment of plaque psoriasis or psoriatic arthritis in adults. Patients can learn to self-administer Tremfya...	Prescription Only Skyrizi, an interleukin inhibitor, is prescribed to alleviate inflammation associated with plaque psoriasis, psoriatic arthritis, or Crohn's disease in adults. The recommended...
Administration
Subcutaneous injection. Learn more.	Subcutaneous Injection. Learn more.
Dosing
100 mg at Week 0, Week 4, and every 8 weeks thereafter. Learn more.	150 mg at Week 0, Week 4, and every 12 weeks thereafter.. Learn more.
Latin Shorthand
100 mg Week 0, 4, q8w. Learn more.	150 mg Week 0, 4 then q12w. Learn more.
Out-Of-Pocket Costs With Copay Card
$5. Learn more.	$5. Learn more.
Annual Cap
$6,000. Learn more.	$6,000. Learn more.
Assistance Expiration
End of each calendar year (subject to change or end without notice). Learn more.	Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Adverse Reactions
Most common (≥1%) adverse reactions associated with TREMFYA include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections. . Learn more.	Most common adverse reactions are: • Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. • Crohn’s Disease (>3%): o Induction: upper respiratory infections, headache, and arthralgia. o Maintenance: arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. . Learn more.
Mechanism of Actions (MoA)
Interleukin 23 Antagonist. Learn more.	N/A. Learn more.
Special Populations
Is TREMFYA safe to use during pregnancy? There are no available data on TREMFYA use in pregnant women to inform a drug associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, TREMFYA may be transmitted from the mother to the developing fetus. In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of guselkumab during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD). Neonatal deaths were observed at 6- to 30-times the MRHD. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Pregnant women should discuss the potential risks and benefits of TREMFYA with their healthcare provider. Is there a pregnancy exposure registry for TREMFYA? Yes, there is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy. Patients should be encouraged to enroll by calling 1-877-311-8972. What is the estimated background risk of major birth defects and miscarriage in the general population? In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. What animal data is available for TREMFYA use during pregnancy? In a combined embryofetal development and pre- and post-natal development study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of guselkumab up to 50 mg/kg (30 times the MRHD based on a mg/kg comparison) from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of one control monkey, three monkeys administered guselkumab at 10 mg/kg/week (6 times the MRHD based on a mg/kg comparison) and three monkeys administered guselkumab at 50 mg/kg/week (30 times the MRHD based on a mg/kg comparison). The clinical significance of these findings is unknown. No guselkumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age. What are the risks associated with guselkumab use during lactation? There is no data on the presence of guselkumab in human milk or the effects on the breastfed infant or milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TREMFYA and any potential adverse effects on the breastfed infant from TREMFYA or from the underlying maternal condition. Is TREMFYA safe and effective for use in pediatric patients? The safety and efficacy of TREMFYA in pediatric patients (less than 18 years of age) have not been established. Are there differences in safety or effectiveness of TREMFYA in geriatric patients? No overall differences in safety or effectiveness were observed between older and younger subjects who received TREMFYA. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.	Is there a pregnancy exposure registry for SKYRIZI? Yes, there is a pregnancy exposure registry for SKYRIZI that monitors outcomes in women who become pregnant while treated with the medication. Patients can enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com. What is the risk of using SKYRIZI during pregnancy? Available data on risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. However, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero-exposed infant. Additionally, there are adverse pregnancy outcomes in women with inflammatory bowel disease. What is the background risk of birth defects and miscarriage in the general population? In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Is SKYRIZI detected in human milk? There is no data on the presence of risankizumab in human milk. However, maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKYRIZI and any potential adverse effects on the breastfed infant from the medication or from the underlying maternal condition. Is SKYRIZI safe and effective in pediatric patients? The safety and efficacy of SKYRIZI in pediatric patients (less than 18 years of age) have not been established. Is there a difference in safety and efficacy of SKYRIZI between older and younger subjects? Of the subjects with plaque psoriasis or psoriatic arthritis exposed to SKYRIZI, a total of 185 subjects were 65 years or older, and 13 subjects were 75 years or older. No overall differences in safety or effectiveness were observed between older and younger subjects who received SKYRIZI. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.

Tremfya®(guselkumab)

Skyrizi®(risankizumab)

Prescription Only

Tremfya, an interleukin inhibitor, is indicated for the treatment of plaque psoriasis or psoriatic arthritis in adults. Patients can learn to self-administer Tremfya...

Prescription Only

Skyrizi, an interleukin inhibitor, is prescribed to alleviate inflammation associated with plaque psoriasis, psoriatic arthritis, or Crohn's disease in adults. The recommended...

Dosage & Administration

Administration

Subcutaneous injection. Learn more.

Subcutaneous Injection. Learn more.

Dosing

100 mg at Week 0, Week 4, and every 8 weeks thereafter. Learn more.

150 mg at Week 0, Week 4, and every 12 weeks thereafter.. Learn more.

Latin Shorthand

100 mg Week 0, 4, q8w. Learn more.

150 mg Week 0, 4 then q12w. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$5. Learn more.

Annual Cap

$6,000. Learn more.

Assistance Expiration

End of each calendar year (subject to change or end without notice). Learn more.

Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

Most common (≥1%) adverse reactions associated with TREMFYA include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections. . Learn more.

Most common adverse reactions are: • Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. • Crohn’s Disease (>3%): o Induction: upper respiratory infections, headache, and arthralgia. o Maintenance: arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. . Learn more.

Mechanism of Actions (MoA)

Interleukin 23 Antagonist. Learn more.

N/A. Learn more.

Special Populations

Is TREMFYA safe to use during pregnancy?

There are no available data on TREMFYA use in pregnant women to inform a drug associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, TREMFYA may be transmitted from the mother to the developing fetus. In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of guselkumab during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD). Neonatal deaths were observed at 6- to 30-times the MRHD. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Pregnant women should discuss the potential risks and benefits of TREMFYA with their healthcare provider.

Is there a pregnancy exposure registry for TREMFYA?

Yes, there is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy. Patients should be encouraged to enroll by calling 1-877-311-8972.

What is the estimated background risk of major birth defects and miscarriage in the general population?

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

What animal data is available for TREMFYA use during pregnancy?

In a combined embryofetal development and pre- and post-natal development study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of guselkumab up to 50 mg/kg (30 times the MRHD based on a mg/kg comparison) from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of one control monkey, three monkeys administered guselkumab at 10 mg/kg/week (6 times the MRHD based on a mg/kg comparison) and three monkeys administered guselkumab at 50 mg/kg/week (30 times the MRHD based on a mg/kg comparison). The clinical significance of these findings is unknown. No guselkumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age.

What are the risks associated with guselkumab use during lactation?

There is no data on the presence of guselkumab in human milk or the effects on the breastfed infant or milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TREMFYA and any potential adverse effects on the breastfed infant from TREMFYA or from the underlying maternal condition.

Is TREMFYA safe and effective for use in pediatric patients?

The safety and efficacy of TREMFYA in pediatric patients (less than 18 years of age) have not been established.

Are there differences in safety or effectiveness of TREMFYA in geriatric patients?

No overall differences in safety or effectiveness were observed between older and younger subjects who received TREMFYA. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.

Is there a pregnancy exposure registry for SKYRIZI?

Yes, there is a pregnancy exposure registry for SKYRIZI that monitors outcomes in women who become pregnant while treated with the medication. Patients can enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com.

What is the risk of using SKYRIZI during pregnancy?

Available data on risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. However, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero-exposed infant. Additionally, there are adverse pregnancy outcomes in women with inflammatory bowel disease.

What is the background risk of birth defects and miscarriage in the general population?

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Is SKYRIZI detected in human milk?

There is no data on the presence of risankizumab in human milk. However, maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKYRIZI and any potential adverse effects on the breastfed infant from the medication or from the underlying maternal condition.

Is SKYRIZI safe and effective in pediatric patients?

The safety and efficacy of SKYRIZI in pediatric patients (less than 18 years of age) have not been established.

Is there a difference in safety and efficacy of SKYRIZI between older and younger subjects?

Of the subjects with plaque psoriasis or psoriatic arthritis exposed to SKYRIZI, a total of 185 subjects were 65 years or older, and 13 subjects were 75 years or older. No overall differences in safety or effectiveness were observed between older and younger subjects who received SKYRIZI. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.

Tremfya® Alternatives