Efficacy and Safety of Ustekinumab for CD

Transcript

David Hudesman, MD: One thing that we have is some longer-term data for ustekinumab since it's been around longer. Maia, why don't you comment on durability of that therapy.

Maia Kayal, MD: We have some great data. So, the initial IM UNITI trial of course showed us that ustekinumab was safe and effective through 3 years. The IM-UNITI open long-term extension trials gave us that data through 5 years. And it was great because it showed us that patients who were in clinical response and had clinical remission maintained that through 5 years and there were no new safety signals during that period; essentially, the adverse events rates per 100 patient years were similar in the placebo arm and the ustekinumab active arm. It was great, it maintained that safety and efficacy over that long-term period of 5 years, which was really nice. Something nice from the long-term extension trial data we saw was that there was no increased risk of immunogenicity. This is what I do in my practice; I don't put them on a concomitant immunomodulator because that risk of immune just is so low. It was nice reassuring data that showed the durability of the drug through 5 years.

Millie Long, MD, MPH: And I'll say amazing safety data. It's been out as long as it has across indications, whether it's psoriatic arthritis, psoriasis, or IBD, obviously the dosing's a little bit different. We haven't seen malignancy signals or serious infection risk associated with it. It's something that I have a lot of confidence in the durability and the safety. We also have through the PIANO pregnancy registry data during pregnancy, so that can become important. A lot of the patients we see are young women who are considering pregnancies and that's reassuring to have that out there.

David Hudesman, MD: One thing that we have is some longer-term data for ustekinumab since it's been around longer. Maia, why don't you comment on durability of that therapy.

Maia Kayal, MD: We have some great data. So, the initial IM UNITI trial of course showed us that ustekinumab was safe and effective through 3 years. The IM-UNITI open long-term extension trials gave us that data through 5 years. And it was great because it showed us that patients who were in clinical response and had clinical remission maintained that through 5 years and there were no new safety signals during that period; essentially, the adverse events rates per 100 patient years were similar in the placebo arm and the ustekinumab active arm. It was great, it maintained that safety and efficacy over that long-term period of 5 years, which was really nice. Something nice from the long-term extension trial data we saw was that there was no increased risk of immunogenicity. This is what I do in my practice; I don't put them on a concomitant immunomodulator because that risk of immune just is so low. It was nice reassuring data that showed the durability of the drug through 5 years.

Millie Long, MD, MPH: And I'll say amazing safety data. It's been out as long as it has across indications, whether it's psoriatic arthritis, psoriasis, or IBD, obviously the dosing's a little bit different. We haven't seen malignancy signals or serious infection risk associated with it. It's something that I have a lot of confidence in the durability and the safety. We also have through the PIANO pregnancy registry data during pregnancy, so that can become important. A lot of the patients we see are young women who are considering pregnancies and that's reassuring to have that out there.

Transcript edited for clarity.