Anthony M. Turkiewicz, MD: Hillary, I’ll let you address the safety and efficacy profile from the results of those trials.
Hillary E. Norton, MD: Guselkumab did demonstrate joint efficacy in both the bio-naїve and bio-experienced populations in terms of the ACR20 [American College of Rheumatology 20% improvement]. And we saw robust ACR20 scores in DISCOVER-2, which was the bio-naїve population, so ACR20 scores of 20%, which is strong for joint scores and even higher out at 52 weeks. I believe we were getting above 70% at 52 weeks. Skin efficacy, in terms of investigator global assessment, was 0 or 1; those are high skin scores. I’ll let Steve speak to that, but there was very high skin clearance and, as John mentioned, improvement in self-assessment of sacroiliitis in terms of the BASDAI [Bath Ankylosing Spondylitis Disease Activity Index]. That was an interesting way to do this. Patients did have documented sacroiliitis either by history or by an x-ray at the time of enrollment in the trial. This was a self-assessment. This is a different way of doing this, and we can talk more about that.
Also, we saw improvement in the patient-reported outcomes as measured by the HAQ-DI [Health Assessment Questionnaire—Disability Index], FACIT [Functional Assessment of Chronic Illness Therapy] fatigue, and SF-36 [Short Form–36]. This was the first time the FACIT fatigue was included in a label. This is significant for our patients because fatigue is quite a concern. We saw improvement in dactylitis, and we saw improvement in enthesitis, so we’re really covering all the bases except for, as John mentioned, a NAPSI [Nail Psoriasis Severity Index] score.
When we look at safety, that is where this really shines. When all of us first saw these safety data we were impressed. When we look at serious adverse events, there were more in the placebo group than there were in the treatment group. That speaks to the immune dysfunction or dysregulation in untreated disease or undertreated disease compared with well-treated disease. We always have to take the disease state into account. But there are very similar infection rates in the placebo group compared with the treatment group. All of this is painting a picture of efficacy in terms of both joint and skin, as well as the other PsA [psoriatic arthritis] domains, with a really strong safety profile.
Anthony M. Turkiewicz, MD: Thank you, Hillary.
John Tesser, MD: Anthony, can I just add 1 thing?
Anthony M. Turkiewicz, MD: Please, John.
John Tesser, MD: At the meeting there’s an abstract and a presentation from the MAXIMISE trial, which is the secukinumab trial, which is a prespecified prospective trial looking at spondylitis and psoriatic arthritis population. Just to let everybody know that now we have some controlled data allowing us to understand how these agents work in the spondylitis patients with PsA.
Anthony M. Turkiewicz, MD: Exactly. By no means is this the only stab looking at it. I’d say perhaps this is the first. In subsequent trials it has set the stage for future looks into this. There’s not 1 perfect way of doing this. But as you were saying, in this meeting and in subsequent meetings we’ll see more data.
Transcript Edited for Clarity