New ‘Level Up’ Data on Upadacitinib (Rinvoq) for Atopic Dermatitis, with Christopher Bunick, MD, PhD

At the 44th Annual Fall Clinical Dermatology Conference, an interview was conducted by the HCPLive editorial team regarding the latest phase 3b/4 clinical trial findings from the ‘Level Up study regarding upadacitinib (Rinvoq) treatment of atopic dermatitis.

During his interview, trial investigator Christopher Bunick, MD, PhD, Yale School of Medicine associate professor, spoke about his team’s main conclusions regarding the success observed by patients with the skin disease treated with upadacitinib.

“So this was divided into 2 periods,” Bunick explained. “We have Period 1 of Level Up, where patients were randomized to either dupilumab per label or upadacitinib, 15 milligrams daily. Then at Week 16, the primary endpoint was read for Period 1 and patients that were receiving dupilumab, if they had greater than EASI-75 response, they completed the trial. If they had less than EASI-75, they were then switched to upadacitinib, 15 milligrams with no washout period.

They continued to complete an additional 16 weeks in the trial, Bunick explained, for investigators to evaluate the effect of switching from dupilumab to upadacitinib. “

“Those that were less than EASI-75 response then went on to get upadacitinib, 30 milligrams, in Period 2,” Bunick said. “Now the caveat in all of that is that at Week 4 and at Week 8, in Period 1, there were opportunities to increase. Patients from upadacitinib 15 milligrams to 30 milligrams, depending on whether they hit EASI-50 at Week 4 or EASI-75 at Week 8, or had less itch response than expected.”

Bunick then highlighted what the data demonstrated for upadacitinib among patients treated in the study.

“Two different time points were looked at: Week 20 and Week 32,” Bunick said. “What we know is that for the patients that did not achieve EASI-75 with dupilumab, almost 80% of those patients achieved EASI-75 by Week 32 on upadacitinib, and it was almost 70% at Week 20 so just 4 weeks after switching from dupilumab to upadacitinib 15 milligrams. Around 70% of patients were achieving that EASI-75 benchmark, and then up to 80% by Week 32.”

Then, Bunick highlighted other notable elements of the findings, specifically related to the stringent composite endpoint of EASI-90 and itch severity 0/1.

“Now if we go out to the stringent composite endpoint of EASI-90 and itch 0/1, we found that 1 in 4 patients that did not achieve EASI-75 with dupilumab hit that stringent endpoint by Week 32,” Bunick explained. “Think about that. When you're switching from dupilumab to upadacitinib 15 milligrams, and you're trying to hit that stringent endpoint of EASI-90 and itch 0/1, 1 in 4 of your patients that didn't respond to dupilumab are going to achieve the most stringent endpoint ever analyzed in a trial on atopic dermatitis in dermatology. That is an incredibly high success rate.”

To find out more about this subject and upadacitinib’s latest trial data, view the full interview segment posted above. For additional information, view our latest conference coverage available here.

The quotes implemented in this interview summary were edited for clarity.