Stelara Shows Real-world Efficacy in Ulcerative Colitis
Real-world data from a multicenter study revealed that Stelara helped patients with ulcerative colitis achieve steroid-free remission, according to research published in Alimentary Pharmacology & Therapeutics.
Aurelien Amiot, from Henri Mondor University Hospital in France, and colleagues wrote that because of relatively high rates of loss of response to anti-TNF and other biologic therapies for UC, there is a growing demand for medications with alternative mechanisms of action. Although studies have shown Stelara (ustekinumb, Janssen) to be effective, real-world data are lacking.
“Real-world studies allow bridging of some data gaps by describing patient experiences that are lacking in clinical trials that tend to exclude certain groups of patients,” they wrote. “Real-world experience series bring important data on the effectiveness and safety of new therapeutic options.”
Researchers assessed the short-term effectiveness and safety of ustekinumab in a retrospective study of 103 patients with UC. Of the patient population, 70% had been previously exposed to at least two anti-TNF agents and 85% had been exposed to Entyvio (vedolizumab, Takeda). The primary outcome was steroid-free remission (defined as a partial Mayo score 2) at weeks 12 to 16 without a rectal bleeding subscore of one or more.
Between weeks 12 and 16, researchers recorded steroid-free clinical remission and clinical remission rates of 35% and 39.8%, respectively. They also found that 19.4% of patients reported the absence of rectal bleeding with normal stool frequency.
In their analysis, Amiot and colleagues determined that a partial Mayo score of at least 6 at inclusion and a history of exposure to both anti-TNF and vedolizumab were negatively associated with steroid-free remission.
In their safety analysis, researchers found that adverse events occurred in 7.8% of patients, while serious adverse events occurred in 3.9% of patients. Two patients had to discontinue the drug before their week 12 to 16 visit and underwent surgery.
“This first large multicenter, real-world study of ustekinumab has shown that it is effective in inducing steroid-free clinical remission in one-third of patients with refractory UC with a good safety profile,” Amiot and colleagues wrote. “Clinical severity and history of both exposure to anti-TNF and vedolizumab therapies are associated with a lower probability of steroid-free clinical remission.” – by Alex Young
Disclosure: Amiot reports receiving consulting fees from AbbVie, Biocodex, Gilead, Hospira, Janssen, Pfizer, Takeda and Tillots, as well as lecture fees and accommodations from AbbVie, Biocodex, Ferring, Hospira, Janssen, MSD, Pfizer, Takeda and Tillots. Please see the full study for all other authors’ relevant financial disclosures.