New data support efficacy, safety of povorcitinib for hidradenitis suppurativa
Key takeaways:
- The newly presented data is from the two STOP-HS trials, both of which met their primary endpoints.
- Povorcitinib was considered well tolerated with no new safety signals.
Newly released data from the phase 3 STOP-HS clinical trial program reveal positive results in hidradenitis suppurativa from povorcitinib treatment, Incyte announced in a press release.
Povorcitinib (INCB45707, Incyte) is a Janus kinase-1 inhibitor that is currently being investigated in phase 3 trials for the treatment of HS, vitiligo and prurigo nodularis.
The newly released data from the phase 3 STOP-HS program, which includes STOP-HS1 and STOP-HS2, show that povorcitinib is potentially safe and effective for the treatment of moderate to severe HS.
“HS is a chronic, oftentimes devastating disease with a limited number of approved therapies,” Jennifer Hsiao, MD, associate professor of dermatology at Keck School of Medicine at the University of Southern California, one of the investigators in the STOP-HS2 trial and a member of Healio Dermatology's Peer Perspective Board, told Healio. “The potential addition of a new therapeutic option with a new mechanism of action for patients with HS is exciting, especially as povorcitinib is the first oral medication to have positive phase 3 results for moderate to severe HS.”
According to the release, the double-blind studies met their primary endpoints, defined as a proportion of patients achieving HS Clinical Response 50 (HiSCR50), in both dose regimens — 45 mg and 75 mg.
Each study enrolled approximately 600 adults , all of which were randomly assigned to receive povorcitinib 45 mg, povorcitinib 75 mg or placebo for 12 weeks.
In STOP-HS1, 40.2% of patients treated with 45 mg povorcitinib and 40.6% of patients treated with 75 mg achieved HiSCR50 vs. 29.7% of placebo-treated patients (P = .024 and P = .022) by week 12.
In STOP-HS2, 42.3% of both the 45 mg and 75 mg groups achieved HiSCR50 compared with 28.6% in the placebo group (P = .004 and P = .003).
A higher proportion of a subgroup of biologic-experienced patients treated with povorcitinib also experienced better outcomes than those treated with placebo in each trial.
In STOP-HS1, 34.2% of the 45 mg group and 37.8% of the 75 mg group achieved HiSCR50, compared to 21.9% of those treated with placebo (P = .0096 and P = .037)
In STOP-HS2, 45% of the 45 mg group and 40% of the 75 mg group achieved HiSCR50 vs. 19.5% in the placebo group (P = .001 and P = .005).
According to the release, more patients treated with povorcitinib also achieved HiSCR75, a reduction in flares and a 3-point or higher decrease in their Skin Pain Numeric Rating Scale scores, compared to patients treated with placebo.
“A major challenge in the current treatment landscape for HS is the heterogenous response to available therapies and the ensuing biologic cycling or swapping,” Hsiao told Healio. “Thus, it was exciting to see that povorcitinib demonstrated an even greater differential in efficacy as compared to placebo among patients who had previously been exposed to biologic therapy.”
Both doses were well tolerated with no new safety signals being observed, according to the release. Povorcitinib maintained a safety profile consistent with previous data.
Incyte reports that these data will be used to support the planned regulatory submission of povorcitinib for the treatment of HS worldwide and will be entered into consideration for upcoming scientific meeting presentation.
Editor’s note: This story has been updated with developments.
For more information:
Jennifer Hsaio, MD, can be reached at jennifer.hsiao@med.usc.edu.