Stelara(ustekinumab)
Immunology· 2434 cited findings· 3 source documents
Company: Johnson & Johnson →
What the regulatory reviews say
Stelara (ustekinumab) is an approved drug, developed by Janssen Biotech, Inc., for the treatment of moderate to severe Crohn’s disease. Clinical Response at Week 6 in Induction Study 3001 showed efficacy rates of 21.5%, 34.3%, and 33.7%. In Induction Study 3002, Clinical Response at Week 6 was observed at 28.7%, 51.7%, and 55.5%. Clinical Remission at Week 44 in Maintenance Study 3003 was 35.9%, 48.8%, and 53.1%. Loss of clinical response in Maintenance Study 3003 was 38.9%, 36.4%, and 28.9%.
Safety findings include 5 malignancies reported in ustekinumab-treated patients, compared to 0 in the placebo group. Nonmelanoma skin cancers were reported in 1.5% of Stelara-treated psoriasis patients, 0.2% in CD patients, and 0.5% in UC patients. Four patients experienced malignancy (other than NMSC) in ustekinumab-treated UC patients. The drug received an Approval regulatory action recommendation.
Key figures — cited to the source page
| Clinical Response at Week 6 (Induction Study 3001) | 34.3 % | Johnson & Johnson — Stelara FDA Review (BLA761044, ORIG 1, 2, p.113 |
| Clinical Response at Week 6 (Induction Study 3002) | 55.5 % | Johnson & Johnson — Stelara FDA Review (BLA761044, ORIG 1, 2, p.114 |
| Clinical Remission at Week 44 (Maintenance Study 3003) | 53.1 % | Johnson & Johnson — Stelara FDA Review (BLA761044, ORIG 1, 2, p.116 |
| Malignancies reported in ustekinumab-treated patients | 5 | JANSSEN BIOTECH — Stelara FDA Review (NDA/BLA 761044, 2021), p.83 |
| Malignancies reported in placebo group | 0 | JANSSEN BIOTECH — Stelara FDA Review (NDA/BLA 761044, 2021), p.83 |
| Nonmelanoma skin cancers in Stelara-treated psoriasis patients | 1.5 % | JANSSEN BIOTECH — Stelara FDA Review (NDA/BLA 761044, 2021), p.83 |
| Recommended Indication | Moderate to severe Crohn’s disease | Johnson & Johnson — Stelara FDA Review (BLA761044, ORIG 1, 2, p.2 |
| Approval status | approved | JANSSEN BIOTECH — Stelara FDA Review (NDA/BLA 761044, 2021), p.80 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.