Ustekinumab Gains FDA Approval as Ulcerative Colitis Treatment


Fourth indication expansion for the 2009 drug.


The FDA has granted the approval of an indication expansion for Johnson & Johnson’s ustekinumab (Stelara) for the treatment of adults with moderately to severely active ulcerative colitis. 

Ustekinuamb is a human interleukin-12 and -23 antagonist originally approved in 2009 for the management of moderate to severe plaque psoriasis in adult patients. From there, the FDA approved three more indication expansions, including the uses to treat adolescent patients with moderate to severe plaque psoriasis, adults with active psoriatic arthritis, and adults with moderately to severely active Crohn’s disease. 

“Because of the individual nature of ulcerative colitis, what works for one patient may not work for another. That is why it is so critical that our ulcerative colitis patients have many different treatment options available to them,” said Caren Heller, MD, Chief Scientific Officer at the Crohn’s & Colitis Foundation in a statement. “The approval of STELARA is extremely important for patients living with moderate to severe ulcerative colitis. STELARA gives patients another option to, hopefully, induce remission and help manage their disease.”

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The most recent approval stems from the study results UNIFI-two phase 3, randomized, double-blind, placebo-controlled, parallel group, multi-centers studies evaluating the safety and efficacy of ustekinumab induction and maintenance therapy. In the induction arm, according to a release, patients received a single dose of ustekinumab IV at 6 mg/kg; during the maintenance arm, eligible patients (those achieving clinical remission by week eight) received 90 mg subcutaneous injections every eight weeks for 44 weeks (or roughly one year post treatment start). 

In the induction arm, 19% of patients achieved clinical remission by week eight, whereas 58% experienced some form of a clinical response by week eight. 

In the maintenance arm, 45% of patients were in remission without the use of corticosteroids after one year. 

Ustekinumab is contraindicated in patients with clinically significant hypersensitivity to the active ingredient or any of its excipients.

Warnings and precautions issued with ustekinumab include Infections (particularly for theoretical mycobacteria, salmonella, and Bacillus Galmette-Guei). Tuberculosis, malignancies, hypersensitivity reactions (anaphylaxis or other), reversibly posterior leukoencephalopathy syndrome, and noninfectious pneumonia. 

Adverse events reported with the use of ustekinumab include nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. 


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