Siliq demonstrated skin clearance and improved quality of life in adult patients with moderate to severe plaque psoriasis with no new safety signals emerging throughout 5 years of treatment in a phase 2, open-label extension study.
“A number of patients achieved clear or almost clear skin within the first 2 weeks of treatment, with further improvements occurring through week 12,” Mark G. Lebwohl, MD, professor and system chair in the department of dermatology of Icahn School of Medicine at Mount Sinai, and colleagues wrote. “Maintenance of efficacy was observed through week 264 when patients had been off treatment for 6 weeks.”
In the parent study of the open-label extension, patients were equally randomly assigned to Siliq (brodalumab, Bausch Health Americas) 140 mg, 210 mg or 280 mg or placebo for 12 weeks. Overall, 181 patients who completed the phase 2 continued in the extension; most patients were men (64.6%), and the mean age at baseline was 43.1 years.
At the baseline visit of the extension study, 148 patients who had received brodalumab in the parent study restarted treatment with brodalumab after a hiatus of at least 6 weeks, and 33 patients who received placebo in the parent study began treatment with brodalumab. All patients received brodalumab 210 mg at baseline and at weeks 1, 2 and then every 2 weeks thereafter. Data were included to week 264 in the study.
For patients weighing up to 100 kg, a protocol amendment was enacted at week 59 allowing 118 patients (65.2%) to switch to brodalumab 140 mg every 2 weeks. At week 123, 30 patients (16.6%) with an inadequate response defined as static physician’s global assessment (sPGA) score of 2 for at least 4 weeks or a single sPGA score of at least 3 during treatment with brodalumab 140 mg every 2 weeks were allowed to increase their dose to 210 mg every 2 weeks.
By week 264, patients had not received study treatment for at least 6 weeks. Of 181 patients who entered the extension, 55 patients discontinued mostly due to consent withdrawal (10.5%) and adverse events (8.8%).
Most patients (63%) had an sPGA score of 1 or less at week 2 (95% CI, 55.3-70.2) and 90.3% at week 12 (95% CI, 84.9-94.2), with 77.3% of patients maintaining this response through week 240 (95% CI, 69.1-84.3).
The proportion of patients with an sPGA score of 1 or less was 87.3% at week 12 (95% CI, 81.5-91.8), which remained in more than 50% of patients through week 240 and was 36.5% in patients at week 264 (95% CI, 29.5-43.9).
Researchers noted modest decreases in treatment response when patients were switched to a lower dose of brodalumab 140 mg as well as a return to pre-dose reduction responses after reintroducing the increased dose in those exhibiting inadequate response, according to the study.
Results were similar for Psoriasis Area and Severity Index (PASI) 75, PASI 90 and PASI 100 with a mean percent improvement in PASI of 95.4% (95% CI, 93.9-96.9). Improvement remained at approximately 90% or higher through week 240.
As for the Dermatology Life Quality Index (DLQI), at baseline, 28.3% of patients had DLQI 0/1, which increased to 83.9% of patients by week 12.
“These data add evidence that supports brodalumab as an efficacious and well-tolerated biologic therapy for the long-term treatment of moderate to severe plaque psoriasis, a lifelong disease,” Lebwohl and colleagues wrote. – by Abigail Sutton
Disclosures: The study was sponsored by Amgen/AstraZeneca. Lebwohl reports he is a consultant for Allergan, Aqua, Arcutis, Boehringer Ingelheim, Leo, Menlo, and Promius. Please see the full study for all other authors’ financial disclosures.