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Hermine Brunner, MD, MSc, MBA, discusses secukinumab treatment in patients with enthesitis-related arthritis and juvenile psoriatic arthritis.
Rheumatology Network interviewed Hermine Brunner, MD, MSc, MBA, to discuss her ACR presentation entitled, “Secukinumab Treatment in Children and Adolescents with Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis: Efficacy and Safety Results from a Phase 3 Study.” Brunner is Professor of Pediatrics at the University of Cincinnati. She directs the Division of Rheumatology at Cincinnati Children's Hospital. She explains the key findings of her study, the clinical significance, and what she is most looking forward to at the ACR Convergence.
Below is a preview of our conversation:
Hermine Brunner, MD, MSc, MBA: Secukinumab is a monoclonal antibody that targets interleukin (IL)-a, which is 1 of the inflammatory cytokines that are involved in the signaling of psoriasis, psoriatic arthritis, and spondyloarthritis. Secukinumab has been found effective for the treatment of adults with psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. These are all adult forms of arthritis whose pediatric counterparts are enthesitis-related arthritis and psoriatic arthritis. Now, because Secukinumab was successful in adults, we were interested in testing the medication in children because there's a dire need of having access to better medication for these children. Enthesitis-related arthritis and juvenile psoriatic arthritis are the 2 categories of juvenile idiopathic arthritis (JIA) that have the poorest long-term prognosis and reflecting an ongoing medical need to have access to better medication. Secukinumab was a very good candidate for that, given the known biology of the disease, and it’s successes when you see adults with similar diseases.
Rheumatology Network: Can you tell me a bit about the study design?
HB: The study was a randomized withdrawal design. And that's a design that has been used quite commonly in pediatrics and pediatric rheumatology. So, in this study, design, all children have active disease and therefore they want to try a new medication or have failed other medications. They have very high disease activity from the get-go. So, all patients got secukinumab in the beginning for 3 months, and for 3 months, we looked at only those who, who had responded to secukinumab. They were then randomized to either continuous secukinumab or placebo during the phase 2 of the study at that time. Almost over 85% of the children had markedly reduced disease activity. So, they were much better. And then they got into the double blinded part of the study. And, let's say, it was a child that was randomized to placebo, they experienced a disease flare more likely than the others. And when a child in this study design had a flare, they only get a little bit worse. So, they're never as bad as in the beginning, they only found a little bit of worsening of the disease. And in this study design, as soon as they had a flare, they were started on the active track again. That study design allows us to minimize placebo exposures in vulnerable populations. And as a parent of a child, you wouldn't want to have your kid being in a study and having a 50/50 chance to get no medication.
RN: Absolutely. What were the key findings of this study?
Well, we found that upon starting secukinumab, children, in the vast majority, had a rapid and sustained response to therapy. By 1 week, we already saw improvement in some, and by 3 months over 32% of the children were in inactive disease status, meaning they had no signs and symptoms of the disease anymore. Mind you, when they were enrolled in the study, on average, they had very high disease activity. And by week 12, the scores had markedly decreased to around 4 which is a low-to-moderate disease activity, so the children already felt much better.