STEQEYMA, a proven biosimilar from Celltrion, provides patients a reliable alternative to Stelara® (ustekinumab) to treat1:
STEQEYMA is an FDA-approved biosimilar of Stelara®, with similar indications, dosing and administration, and MOA1*
Comparable efficacy and safety to Stelara®—shown to 52 weeks2,3
Patient-friendly, prefilled syringe, with similar dosing to Stelara1,4
Backed by Celltrion’s patient and practice support programs
MOA, mechanism of action.
*See full indications for STEQEYMA.
STEQEYMA and Stelara results were similar at week 122
Explore ResultsANCOVA, analysis of covariance; FDA, Food and Drug Administration; mITT, modified intention-to-treat; PASI, Psoriasis Area and Severity Index; PPS, per-protocol set; TP, treatment period.
†Analysis used ANCOVA and multiple imputation (per FDA protocol). In the case of the per-protocol set, patients received study drug at weeks 0 and 4 and had PASI data available at baseline and week 12.2
STEQEYMA is available in a user-friendly, prefilled syringe for ease of use, precision dosing, and reduced medication errors1
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Find ResourcesReferences: 1. STEQEYMA Prescribing Information. Celltrion, Inc.; 2024. 2. Papp KA, Lebwohl MG, Thaci D, et al. Efficacy and safety of candidate biosimilar CT-P43 originator ustekinumab in moderate to severe plaque psoriasis: 28-week results of a randomised, active-controlled, double blind, phase III study. BioDrugs. 2023;38(1):121-131. 3. Papp KA, Lebwohl MG, Thaci D, et al. Efficacy and safety of candidate biosimilar CT-P43 originator ustekinumab in moderate to severe plaque psoriasis: 28-week results of a randomised, active-controlled, double blind, phase III study [supplementary data submitted for publication but not yet published]. BioDrugs. 4. Stelara Prescribing information. Janssen Pharmaceutical Company; 2024.
Contraindications. STEQEYMA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA.
Infections. Ustekinumab products, including STEQEYMA, may increase the risk of infections and reactivation of latent infections, including serious bacterial, mycobacterial, fungal, and viral infections requiring hospitalization. Reported infections include pneumonia, gastroenteritis, cellulitis, sepsis, cholecystitis, anal abscess, listeria meningitis, and ophthalmic herpes zoster. Avoid starting STEQEYMA in patients with active infections until resolved, and assess risks in those with chronic or recurrent infections. Advise patients to seek medical care for signs of infection. Discontinue STEQEYMA for serious infections until treated or resolved.
Theoretical Risk for Particular Infections. Genetic IL-12/IL-23 deficiencies are linked to disseminated infections (e.g., mycobacteria, salmonella, and BCG). It is unknown whether IL-12/IL-23 blockade from ustekinumab products may cause similar susceptibility. Consider diagnostic testing, such as tissue or stool cultures, based on clinical circumstances.
Pre-treatment Evaluation for Tuberculosis (TB). Evaluate patients for TB prior to starting STEQEYMA. Avoid using STEQEYMA in patients with active tuberculosis. Treat latent TB before starting STEQEYMA and consider TB therapy for patients with unclear treatment history. Monitor for signs of active TB during and after treatment.
Malignancies. Ustekinumab products are immunosuppressants that may increase the risk of malignancy. Malignancies occurred in clinical trials, and IL-12/IL-23 inhibition increased malignancy risk in rodent models. The safety in patients with a history of malignancy is unknown. Post-marketing reports include rapid onset of multiple cutaneous squamous cell carcinomas in patients with risk factors for non-melanoma skin cancer. Monitor all patients, especially those over 60, with prolonged immunosuppressant use, or a history of PUVA treatment.
Hypersensitivity Reactions. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STEQEYMA.
Posterior Reversible Encephalopathy Syndrome (PRES). Cases of PRES have been reported in clinical trials and postmarketing, with symptoms like headache, seizures, confusion, visual disturbances, and imaging changes. Onset ranged from days to over a year after starting ustekinumab. Patients recovered after discontinuation and supportive care. Monitor for PRES symptoms, and if suspected, treat promptly and discontinue STEQEYMA.
Immunizations. Ensure patients receive all age-appropriate immunizations before starting STEQEYMA. Avoid live vaccines during treatment and for one year before and after discontinuation. Do not administer BCG vaccines during this time. Use caution with live vaccines for household contacts due to the risk of shedding and transmission. Non-live vaccines may have a reduced immune response during STEQEYMA treatment.
Noninfectious Pneumonia. Noninfectious pneumonia, including interstitial, eosinophilic, and cryptogenic organizing pneumonia, has been reported with ustekinumab, presenting as cough, dyspnea, and interstitial infiltrates after 1–3 doses. Serious cases included respiratory failure and prolonged hospitalization. Patients improved with discontinuation and corticosteroids. Discontinue STEQEYMA and treat if confirmed.
Adverse Reactions
The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were:
Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
CD induction: vomiting
CD maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
UC induction: nasopharyngitis
UC maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.
Please see full Prescribing Information.
STEQEYMA (ustekinumab-stba) is a human interleukin-12 and -23 antagonist indicated for the treatment of:
STEQEYMA (ustekinumab-stba) is a human interleukin-12 and -23 antagonist indicated for the treatment of:
Contraindications. STEQEYMA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA.
Infections. Ustekinumab products, including STEQEYMA, may increase the risk of infections and reactivation of latent infections, including serious bacterial, mycobacterial, fungal, and viral infections requiring hospitalization. Reported infections include pneumonia, gastroenteritis, cellulitis, sepsis, cholecystitis, anal abscess, listeria meningitis, and ophthalmic herpes zoster. Avoid starting STEQEYMA in patients with active infections until resolved, and assess risks in those with chronic or recurrent infections. Advise patients to seek medical care for signs of infection. Discontinue STEQEYMA for serious infections until treated or resolved.
Theoretical Risk for Particular Infections. Genetic IL-12/IL-23 deficiencies are linked to disseminated infections (e.g., mycobacteria, salmonella, and BCG). It is unknown whether IL-12/IL-23 blockade from ustekinumab products may cause similar susceptibility. Consider diagnostic testing, such as tissue or stool cultures, based on clinical circumstances.
Pre-treatment Evaluation for Tuberculosis (TB). Evaluate patients for TB prior to starting STEQEYMA. Avoid using STEQEYMA in patients with active tuberculosis. Treat latent TB before starting STEQEYMA and consider TB therapy for patients with unclear treatment history. Monitor for signs of active TB during and after treatment.
Malignancies. Ustekinumab products are immunosuppressants that may increase the risk of malignancy. Malignancies occurred in clinical trials, and IL-12/IL-23 inhibition increased malignancy risk in rodent models. The safety in patients with a history of malignancy is unknown. Post-marketing reports include rapid onset of multiple cutaneous squamous cell carcinomas in patients with risk factors for non-melanoma skin cancer. Monitor all patients, especially those over 60, with prolonged immunosuppressant use, or a history of PUVA treatment.
Hypersensitivity Reactions. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STEQEYMA.
Posterior Reversible Encephalopathy Syndrome (PRES). Cases of PRES have been reported in clinical trials and postmarketing, with symptoms like headache, seizures, confusion, visual disturbances, and imaging changes. Onset ranged from days to over a year after starting ustekinumab. Patients recovered after discontinuation and supportive care. Monitor for PRES symptoms, and if suspected, treat promptly and discontinue STEQEYMA.
Immunizations. Ensure patients receive all age-appropriate immunizations before starting STEQEYMA. Avoid live vaccines during treatment and for one year before and after discontinuation. Do not administer BCG vaccines during this time. Use caution with live vaccines for household contacts due to the risk of shedding and transmission. Non-live vaccines may have a reduced immune response during STEQEYMA treatment.
Noninfectious Pneumonia. Noninfectious pneumonia, including interstitial, eosinophilic, and cryptogenic organizing pneumonia, has been reported with ustekinumab, presenting as cough, dyspnea, and interstitial infiltrates after 1–3 doses. Serious cases included respiratory failure and prolonged hospitalization. Patients improved with discontinuation and corticosteroids. Discontinue STEQEYMA and treat if confirmed.
Adverse Reactions
The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were:
Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
CD induction: vomiting
CD maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
UC induction: nasopharyngitis
UC maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.
Please see full Prescribing Information.
STEQEYMA (ustekinumab-stba) is a human interleukin-12 and -23 antagonist indicated for the treatment of: