Patients with hidradenitis suppurativa sustain clearance up to 40 weeks with upadacitinib
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Key takeaways:
- 38.3% of the upadacitinib group achieved the primary endpoint compared with 23.8% of the placebo group.
- Upadacitinib sustained clearance in patients up to 40 weeks.
NEW ORLEANS — Phase 2 clinical trial results confirmed the benefit of upadacitinib, a selective Janus kinase 1 inhibitor, in the treatment of hidradenitis suppurativa, according to a presentation here.
“While it’s too early to compare to other studies, this study confirms that Janus kinase 1 [JAK1] inhibition is now a validated therapeutic approach in hidradenitis suppurativa,” Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School and CEO and president of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, told Healio.
In a phase 2, multicenter, randomized, placebo-controlled, double-blind study, adults with moderate to severe hidradenitis suppurativa (HS) were randomly assigned 2:1 to receive 30 mg of upadacitinib (Rinvoq, AbbVie) or placebo once daily. After 12 weeks, patients on placebo were switched to upadacitinib 15 mg through week 48.
The primary endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR), defined as a reduction of at least 50% in inflammatory nodule count without an increase in abscess or draining fistula count.
Results, which were presented at the American Academy of Dermatology Annual Meeting, showed that 38.3% (n = 47) of upadacitinib-treated patients achieved the primary endpoint compared with 23.8% (n = 21) of the placebo group at week 12.
Also, 36.4% (n = 33) of the upadacitinib group achieved the key secondary endpoint of a greater than or equal to 30% reduction and 1 unit reduction in Patient Global Assessment of Skin Pain compared with 33.3% (n = 12) of the placebo group.
HiSCR response was maintained with upadacitinib 30 mg through week 40.
The study reported one adverse event of worsening HS which led to discontinuation. Overall, the drug was well tolerated with one malignancy reported and no major adverse cardiovascular events or venous thromboembolisms.
“This study demonstrated that upadacitinib reduced the nodules and abscesses that affect patients with HS and paves the way to the development of new and much needed treatment options for patients,” Kimball said. “Future studies will help clarify how to use these agents, some of which are already approved for other uses, including dermatologic diseases in the U.S.”
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Kimball AB, et al. Efficacy and safety of upadacitinib in moderate to severe hidradenitis suppurativa: A phase 2, randomized, placebo-controlled study. Presented at: American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans.
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