- Blauvelt A. Efficacy and safety of switching from dupilumab to upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension trial. D1T01.3B, EADV Congress 2021, 29 Sept–2 Oct.
The open-label extension OLE study (NCT04195698) evaluated the long-term safety and efficacy of switching from dupilumab to upadacitinib in patients with moderate-to-severe AD1. The initial Heads Up trial (NCT03738397) was a 24-week, head-to-head, phase 3b investigation that demonstrated superiority of upadacitinib over dupilumab not only in the primary but also in all ranked secondary endpoints.
After week 24, patients who had been in the upadacitinib 30 mg arm continued their treatment in the extension trial, while subjects in the former dupilumab 300 mg group were switched to 30 mg upadacitinib up to week 52. Prof. Andrew Blauvelt (Oregon Medical Research Center, OR, USA) presented results from the current interim analysis of OLE at week 40.
Of a total of 484 participants in OLE, 245 switched from dupilumab to upadacitinib, the others were continuously treated with upadacitinib. Baseline data included a mean age of around 36 years and about 44% were women. In Heads Up, the mean Eczema Area and Severity Index (EASI) score and body surface area (BSA) were around 30% and 46%, respectively, while in OLE the matching values were about 3% and 6% as patients had already received therapy.
Focussing on the OLE interim results, Prof. Blauvelt stated that those who switched over to upadacitinib showed a very clear improvement. The rate of switched participants with EASI 100 increased from 16% in Heads Up to 42.4% in OLE, EASI 90 from 66.4% to 87.7%, and EASI 75 from 85.7% to 96.6%, respectively. Furthermore, itch improvement ≥4 on the Worst Pruritus-Numerical Rating Scale also ameliorated markedly.
Treatment-emergent adverse events were assessed through week 40. “We see that the rate of adverse events remained fairly stable over time; they are a little higher in patients who stayed on continuous upadacitinib,” Prof. Blauvelt said. However, he also reported 1 death from tuberculosis in the upadacitinib group. “Looking at the side effects of interest for a JAK inhibitor, you see a fairly consistent profile with what we are used to with upadacitinib and other JAK inhibitors,” he further elaborated.
“We are showing here that switching from dupilumab and upadacitinib results in significant improvements and efficacy and higher levels of efficacy than we would see with dupilumab alone,” Prof. Blauvelt summarised.