- The Janssen Pharmaceutical Companies, a unit of Johnson & Johnson JNJ, announced efficacy and safety data for Stelara (ustekinumab) in Crohn's disease (CD) and ulcerative colitis (UC), including data from the SEAVUE study, a head-to-head study of biologic therapies.
- Data were presented at the Clinical Science Late-Breaking Abstract Plenary session.
- The results showed that Stelara failed to meet the primary endpoint of statistical superiority versus AbbVie Inc's ABBV Humira (adalimumab).
- At the 52-week mark, 64.9% of Stelara patients had hit clinical remission, compared with 61% of patients taking Humira, a numerical difference but not a statistically significant one.
- Digging deeper into the data, Stelara demonstrated high rates of clinical remission, corticosteroid-free remission, clinical response, and endoscopic response through one year in biologic-naïve patients, but none were statistically significant.
- Around 61% of patients on the J&J drug hit corticosteroid-free remission versus 57.4% of Humira patients.
- Around 6% more patients on Stelara achieved clinical response than those on Humira, and self-reported symptom remission was about 1% higher in the Stelara arm.
- Meanwhile, Humira helped around 3% more patients hit clinical remission by week 16. It also fared slightly better than Stelara at helping certain patients achieve endoscopic remission.
- A safety difference in Stelara's favor was observed. Specifically, 6.3% of Stelara patients and 11.3% of Humira patients stopped treatment because of side effects.
- Price Action: JNJ shares are down 0.56% at $170 during the premarket session on the last check Monday.
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