Physician Views: Sizing up Stelara’s potential role in ulcerative colitis

Phase III clinical data presented last week at the American College of Gastroenterology (ACG) meeting confirm that Johnson & Johnson’s Stelara is an effective treatment for ulcerative colitis. This will have come as little surprise to many experts in the field given Stelara’s current labelling, among other indications, for the treatment of Crohn’s disease.

Where Stelara will potentially fit into the treatment paradigm remains less clear though it’s not unreasonable to expect some use in the first-line setting, suggests one key opinion leader.

To get a better idea, we are snap-polling gastroenterologists in the US and EU3 (France, Germany and UK) markets with the following questions…

Q. Results from the 961-patient UNIFI study show that 15.6 percent of moderate-to-severe ulcerative colitis patients who received a single 130mg dose of Stelara (ustekinumab) and 15.5 percent of those given a single dose of Stelara (ustekinumab) based on weight achieved clinical remission at week eight, compared with 5.3 percent in the placebo group. 

Key secondary endpoints were also met; 26.3 percent of patients receiving fixed dose Stelara and 27 percent given a weight-based dose experienced endoscopic healing at week eight, versus 13.8 percent for placebo. In the two respective Stelara groups, 51.3 percent and 61.8 percent of patients achieved clinical response, compared with 31.3 percent for placebo, while results for mucosal healing were 20.3 percent, 18.4 percent and 8.9 percent, respectively.

Using a five-point scale (1=not compelling/5 = extremely compelling) how compelling are these data?

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Q. Through week 8, adverse events (AEs), serious AEs and infections (including serious infections) were reported in similar proportions across the Stelara (ustekinumab) and placebo treatment groups. No malignancies, opportunistic infections or tuberculosis were reported through week 8. One death from an esophageal varices hemorrhage was reported for a patient with no known history of cirrhosis or portal hypertension in the ~6mg/kg dose group prior to week 8, believed to be unrelated to the study medication.

Using a five-point scale (1=not compelling/5 = extremely compelling) how compelling are these data?

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Q. Using a five-point scale (1= no adoption / very fast adoption) and assuming Stelara (ustekinumab) is approved for the treatment of moderate-to-severe ulcerative colitis, how quickly would you adopt it into the treatment paradigm?

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Q. About 50 percent of participants in the UNIFI study are considered biologic refractory, and 17 percent have a history of inadequate response or intolerance to an anti-TNF and/or Entyvio (vedolizumab).

If approved for the treatment of moderate-to-severe ulcerative colitis, in what line of therapy would you most frequently expect to prescribe Stelara (ustekinumab)?

First-line (before anti-TNF therapy)

Second-line (after anti-TNF therapy but before Entyvio)

Third-line (after Entyvio)

Fourth-line (after Xeljanz)

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Q. Xeljanz (tofacitinib) was also approved for the treatment of moderate-to-severe ulcerative colitis earlier this year. In five years’ time which scenario do you think will most accurately reflect you prescribing habits?

I will prescribe Xeljanz much more frequently than Stelara

I will prescribe Xeljanz slightly more frequently than Stelara

I will prescribe similar amounts of Xeljanz and Stelara

I will prescribe Stelara slightly more frequently than Xeljanz

I will prescribe Stelara much more frequently than Xeljanz

I will prescribe neither

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here

As always, FirstWord would very much like to receive your feedback and suggestions.

Note: FirstWord Physician Views are a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties in major markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

Disclaimer: FirstWord follows market research best practices in conducting its Physician Views polls.  However, Physician Views results should be considered directional and clients should use their market research resources for statistical analysis and conclusions required with very high confidence levels.

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