Physician Views snap poll: Gauging US gastroenterologist response to FDA black box labelling for Pfizer's Xeljanz in ulcerative colitis

The FDA recently approved new warnings about an increased risk of blood clots and death associated with the 10 mg twice-daily dose of Pfizer's Xeljanz (tofacitinib), which is used in patients with ulcerative colitis. The agency also said it would limit use of the JAK inhibitor in ulcerative colitis to certain patients who are not treated effectively or who experience severe side effects with certain other medicines.

This follows similar restrictions in use recommended by the European Medicines Agency (EMA) in May (see Physician Views Poll Results: Xeljanz down but far from out as safety concerns squeeze use in UC).

In response to the FDA's labelling changes, we are snap-polling US gastroenterologists with the following questions to ascertain what impact they may have on the use of Xeljanz for the treatment of ulcerative colitis…

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Q. What is your overall clinical assessment - of efficacy and safety - of Xeljanz (tofacitinib) 10 mg twice-daily for the treatment of ulcerative colitis?

1 - Very negative

2 - Negative

3 - Neutral

4 - Positive

5 - Very positive

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Q. Approximately what percentage of UC patients under your care do you currently treat with the 10 mg twice-daily dose of Xeljanz?

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Q. The FDA has approved new warnings about an increased risk of blood clots and death with the 10 mg twice-daily dose of Xeljanz.

In addition, the approved use of Xeljanz for UC will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines. While the increased risks of blood clots and of death were seen in patients taking this dose for rheumatoid arthritis, these risks may also apply to those taking tofacitinib for UC

What impact, if any, will these labelling changes have on reducing your future utilisation of the 10 mg twice-daily dose of Xeljanz as a treatment for UC in patients already receiving the drug?

No impact

Slight impact

Moderate impact

Significant impact

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Q. And what impact, if any, will these labelling changes have on reducing your future utilisation of the 10 mg twice-daily dose of Xeljanz as a potential treatment for UC in patients previously untreated with the drug?

No impact

Slight impact

Moderate impact

Significant impact

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Q. If you plan to reduce you future utilisation of the 10 mg twice-daily dose of Xeljanz for the treatment of UC, please state which other product you would expect to prescribe most frequently as an alternative.

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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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