Linda Stein Gold, MD: Phase 4 Data on Risankizumab for Moderate Plaque Psoriasis

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In this interview with Dr. Gold, she describes her team’s recent findings from a phase 4 head-to-head study on risankizumab for psoriasis patients.

In this interview with HCPLive, Linda Stein Gold, MD, spoke about her team’s latest findings from a phase 4, head-to-head trial in which risankizumab outperformed apremilast as a systemic therapy for adults with moderate psoriasis by several measures.1

Gold is known for her work as director of research and as head of the Division of Dermatology at the Henry Ford Health System.

“You know, when we think about our psoriasis patients, we've studied them in with multiple different treatment modalities, and risankizumab has been studied in moderate-to-severe psoriasis patients, and it's been shown to be very effective,” she said. “We actually studied it with an active control of other biologic agents, including TNF inhibitors, IL-1223, as well as IL-17 inhibitors, and it's been shown to be safe and actually superior to other biologic agents.”

She adds that apremilast, on the other hand, is an oral medication that's been FDA-approved for psoriasis and all treatments and has been studied in moderate-to-severe disease and even mild-to-moderate disease. The drug is often a first line of treatment when patients want to go beyond topical therapy, Gold adds.

“Especially for our moderate patients, it's a very commonly used medication,” she said. “So the question came up, you know, if we look at that moderate population, how does a highly effective biologic agent like risankizumab compare to a very frequently-prescribed medication, which has also been shown to be effective and safe like apremilast?”

Gold then went into a description of some of the major findings from her team’s research, noting that the drug achieved each of its primary and secondary endpoints.

“What we found was the drugs perform the way we expected them to perform,” she explained. “We know that risankizumab is a highly effective biologic agent. And we saw that when we looked at those really high benchmarks. Really asking drugs to perform in a way that gets those patients under control, using measurements that we didn't use in the past, before the past several years. Looking at it and seeing 90% improvement in their PASI score, we saw that risankizumab actually performed very, very well in this moderate population, and did actually outperform apremilast in getting those patients to a 90% improvement.”

Gold also noted that risankizumab outperformed by getting these patients to almost clear at Week 16.

“So this was a highly effective drug, it actually got those moderate patients to a very effective clinical endpoint in a rapid manner,” she said. “You know, in 16 weeks, we're sitting seeing patients getting to clear and almost clear, and apremilast is performing the way we expected it to based on its prior trials, but didn't perform quite as well as what we saw with risankizumab.”

She noted that, regarding patient satisfaction scores, risankizumab also appeared to outperform apremilast.

“When we ask patients about the effectiveness of the medication we saw with a biologic agent, it was around 80% versus about 47% with apremilast when we asked about convenience,” Gold said. “Also people didn't mind getting an injection and we saw, for convenience, they said about 85% of the time they were happy with the risankizumab, and about 69% of the time with the apremilast.”

Gold also touched upon the therapy’s safety profile in her discussion of the team’s results.

“Yeah, both of these drugs are actually very safe medications,” she explained. “And as a medical dermatologist, I'm very comfortable using both of these medications. We did find a higher incidence of adverse events that occurred with the apremilast group versus the risankizumab group. About 61% versus about 42% of the people who discontinued in the first 16 weeks due to something and adverse events related to drug was actually higher again in the apremilast group. About 7% versus no patients in the first 16 weeks who discontinued due to an adverse event due to the risankizumab.”

Later, Gold spoke broadly about the different therapies currently available for patients with different types of psoriasis.

“I think that for those moderate patients who are systemic eligible, I think it's important to provide them with the safest, most effective medication that's right for them,” she explained. “...I'm very optimistic. I think that psoriasis is one of the most challenging conditions that we treat. And with great research and development, this has become a disease state that we actually enjoy treating.”

Gold noted that she finds it wonderful for not only patients but also for physicians to see patients reaching higher efficacy levels than they have ever reached before.

The quotes contained in this interview description were edited for clarity.

References

  1. AbbVie. Skyrizi™ (risankizumab) Achieved Superiority Versus Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate to Severe Plaque Psoriasis in Phase 4 Head-to-Head Study [press release]. Published July 26, 2023. Accessed July 26, 2023. Available from: https://news.abbvie.com/news/press-releases/skyrizi-risankizumab-achieved-superiority-versus-apremilast-for-co-primary-endpoints-among-adult-patients-with-moderate-plaque-psoriasis-in-phase-4-head-to-head-study.htm.
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