Povorcitinib outperforms placebo as treatment for hidradenitis suppurativa
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Key takeaways:
- A higher proportion of povorcitinib- vs. placebo-treated patients achieved an HS Clinical Response.
- Adverse events were similar between povorcitinib and placebo groups.
Patients with hidradenitis suppurativa treated with povorcitinib achieved better outcomes than those treated with placebo, according to a study.
“Povorcitinib is an oral, small-molecule, selective [Janus kinase (JAK)] 1 inhibitor,” Joslyn S. Kirby, MD, MS, MEd, of Penn State Health Milton S. Hersey Medical Center, and colleagues wrote. “Two proof-of-concept phase 2 studies demonstrated that povorcitinib was associated with improved outcomes and was generally well tolerated in patients with moderate to severe [hidradenitis suppurativa (HS)].”
To further assess the efficacy and safety of povorcitinib in patients with HS, the researchers conducted a multicenter, parallel-group, placebo-controlled, phase 2 study.
Two hundred and nine patients with HS were randomly assigned to receive three doses of povorcitinib at either 15 mg (n = 52), 45 mg (n = 52) or 75 mg (n = 53) or placebo (n = 52) over 16 weeks. Nine patients discontinued the study due to adverse events, leaving 83.3% of patients completing the study.
By week 16, patients treated with povorcitinib saw a significant decrease in their abscess and inflammatory nodule count from baseline compared with placebo-treated patients. The least squares mean changes from baseline were –5.2 in the 15 mg group (P = .0277), –6.9 in the 45 mg group (P = .0006) and –6.3 in the 75 mg group (P = .0021) compared with –2.5 in the placebo group.
At week 16, HS Clinical Response was achieved by 48.1% of the 15 mg group (P = .0445), 44.2% of the 45 mg group, 45.3% of the 75 mg group vs. 28.8% of the placebo group.
The rates of treatment-emergent adverse events between the povorcitinib and placebo groups were comparable (60% vs. 65.4%, respectively), with 21.3% and 23.1% of those events being treatment-related adverse events, respectively.
Five serious adverse events, including fall and rib fracture, herniated disc, pulmonary embolism and pneumonia, occurred in three povorcitinib-treated patients, and four serious adverse events, including cholecystitis, atrial fibrillation and limb abscess and bacterial infection, occurred in three placebo-treated patients.
“Povorcitinib demonstrated rapid clinical efficacy for HS, with no evidence of increased risk of [adverse events] across doses evaluated,” the authors wrote. “These promising results support further evaluation of the efficacy and safety of povorcitinib in the ongoing phase 3 registrational studies of patients with moderate to severe HS.”
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