Clinical trials in PsA slowly leading rheumatologists toward personalized medicine
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While the rheumatology community often finds itself behind other specialties in head-to-head trials of drugs or drug classes, new data may help clinicians in decision-making, according to a presenter at ACR 2020.
“We are incredibly fortunate to be able to have so many treatment options for our patients,” Arthur Kavanaugh, MD, director of the Center for Innovative Therapy at the University of California, San Diego, said in his presentation. “The challenge for clinicians is how to use them.”
A broad spectrum of therapeutic options, from TNF inhibitors, interleukin-12/23 and IL-17 inhibitors, JAK inhibitors and phosphodiesterase type 4 inhibitors, to NSAIDS and DMARDs are under investigation, largely with the goal of meeting that challenge.
The optimal way to fully understand the clinical utility of these drugs in individual patients and patient populations is to conduct head-to-head trials, according to Kavanaugh. “In rheumatology, we are catching up [to other specialties] in head-to-head trials,” he said. “There have not been as many historically.”
In the SEAM-PsA trial, investigators compared the TNF inhibitor etanercept (Enbrel, Amgen) with methotrexate or the combination of the two drugs. Kavanaugh noted that there was “not a tremendous difference” between the approaches in terms of ACR20 response at 24 weeks. He noted that methotrexate performed well in peripheral joint domains.
As for the combination, while skin response improved to some degree, the two drugs together did not perform as well as Kavanaugh expected. “I would expect there to be some synergy,” he said.
Turning to the SPIRIT-H2H study, researchers compared the IL-17 inhibitor ixekizumab (Taltz, Lilly) with adalimumab (Humira, Abbvie) as assessed by the “unique outcome” of PASI100 score and ACR50 response, according to Kavanaugh.
Ixekizumab demonstrated superiority that was driven by skin response. “IL-17 [drugs are] better for skin psoriasis,” Kavanaugh said.
In the EXCEED study, researchers compared the IL-17 inhibitor secukinumab (Cosentyx, Novartis) with adalimumab in patients with an incomplete response to a previous DMARD. While secukinumab was “definitely better” in terms of skin response, as expected, the drug showed “no lagging” across domains such as enthesitis or functional status, according to Kavanaugh.
“These data are intriguing,” he said. “But what we want is a follow up to determine which patient would have done better on which therapy.”
The EQUATOR study showed “not bad” skin responses and “not unreasonable” PASI75 response for the JAK inhibitor filgotinib (Jyseleca, Gilead). “Seeing data on peripheral arthritis and the skin raises questions about where to sequence drugs and possibly for combination therapy,” Kavanaugh said.
To that point, Kavanaugh offered some practical advice for clinicians helping patients choose the therapy that will meet their needs. “You have to look at what domains are most important to the patient,” he said.
Looking to the future, Kavanaugh suggested that the timing of intervention should be the next frontier of study, along with the sequencing of drugs and drug classes in PsA. “Regarding treat-to-target, we have to learn these agents a little better for personalized medicine,” he said. “We still have to learn how we provide the right drug for the right patient.”
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Kavanaugh A. Psoriatic Arthritis Clinical Trials Update. Presented at: ACR Convergence 2020; November 5-9, 2020 (virtual meeting).
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