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J&J’s Stelara Succeeds in Phase III Ulcerative Colitis Study


Johnson & Johnson JNJ announced new data from a phase III study, evaluating its drug Stelara in adults with moderate-to-severe ulcerative colitis (“UC”). The eight-week induction data from the pivotal phase III UNIFI study showed that a single intravenous (IV) dose of the medicine induces clinical remission and response in UC patients who had failed prior therapy.

Please note that Stelara is not yet marketed for the UC indication. Stelara is presently marketed for the treatment of moderate-to-severe plaque psoriasis, active psoriatic arthritis and Crohn's disease.

The data from UNIFI showed that after eight weeks of treatment, clinical remission was achieved in 15.6% of UC patients who received the 130 mg dose of Stelara and 15.5% of patients receiving the 6 mg/kg dosing compared to 5.3% for those receiving placebo. The secondary endpoints included the proportion of patients in clinical response, endoscopic healing, as well as improvement in health-related quality of life.

These measures were also significantly higher at week 8 in the Stelara treatment arm compared to placebo arm. Meanwhile, adverse events proportion was similar in both the Stelara and placebo arms. However, one death was reported in the 6mg/kg dose group in a patient with no known history of cirrhosis or portal hypertension.

Ulcerative colitis is a complicated immune disease in which the patients suffer from persistent diarrhea, abdominal pain, blood in stool, loss of appetite, weight loss and fatigue. More than half of the UC patients fail to achieve remission with currently available conventional or biologic therapies. The successful induction data from the UNIFI study highlights the potential of Stelara for UC patients in the future.

The stock has dipped 0.3% this year so far against an increase of 7.1% recorded by the industry.

Stelara sales rose 33% to $2.4 billion in the first half of 2018. Stelara is gaining market share particularly driven by strong uptake in the new indication for Crohn's disease for which approval was received both in the United States and the EU in 2016.

Other marketed UC treatments include Pfizer’s PFE JAK inhibitor, Xeljanz, AbbVie’s ABBV Humira and Shire’s SHPG Lialda.

J&J currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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