Dr Loftus reviews his poster presentation on health-related quality of life among patients with Crohn disease treated with ustekinumab or adalimumab in the SEAVUE trial.

Edward Loftus, MD, is a professor of medicine at the Mayo Clinic in Rochester, Minnesota.

TRANSCRIPT:

I’m Ed Loftus, I'm a professor of medicine at Mayo Clinic in Rochester, Minnesota. I wanted to talk to you today about one of the posters that was presented at the ACG meeting.

This is the poster on health-related quality of life with ustekinumab versus adalimumab for induction and maintenance therapy of moderate-to-severe Crohn's disease, or also known as the SEAVUE trial. This poster specifically looked at different parameters of the inflammatory bowel disease questionnaire.

As you know, this is a disease-specific quality of life instrument that has been around now for almost 30 years. This is a validated instrument and is often used in clinical trials as an adjunct to the usual clinical outcomes.

Recall that the SEAVUE trial was a randomized treat-straight-through trial of the standard dose of ustekinumab versus adalimumab for patients with bio-naive Crohn's disease, so there was no dose escalation of this, since the standard FDA-approved dose in the US for both drugs, and was a double-blind, double-dummy.

The primary endpoint was at week 52. As you recall, the primary endpoint was not met. In other words, the clinical remission rates at week 52 were high in both groups. It was over 60%, but they were not statistically significantly different. With the IBDQ, this was administered at baseline and also at week 52.

Recall that the IBDQ is 32 questions. It's broken up into 4 domains and that includes bowel symptoms, emotional function, systemic symptoms, and social function. For each of those 4 domains, at the end of the study, there was essentially no statistically significant difference between the scores in those 4 domains and same with the total IBDQ score.

Numerically, the ustekinumab score was slightly higher for the total and for each of those 4 domains, but not statistically significantly different. As an example, for the total score, it had risen 50 points in the ustekinumab treated patients and 43 points in the adalimumab treated patients.

Now, a clinically meaningful difference is about 16 points. This was well within that range. Overall, if you define IBDQ response as a 16-point increase, that was met in 66% of ustekinumab patients and 63% of the adalimumab patients.

Then, if you look at IBDQ remission, which is defined as an IBDQ score greater than 170, it was met in 53% of ustekinumab patients and almost 52% of the adalimumab-treated patients.

The good news is that both drugs were effective for bio-naive Crohn's patients, and the quality of life improved in both groups. That would be expected given the clinical endpoint responses. It's good news for patients and for providers that we have 2 great first-line biologic options in patients with Crohn's disease. Thanks.