Long-term data show that treatment of plaque psoriasis with brodalumab is safe and effective, according to a study published in the Journal of the American Academy of Dermatology. Brodalumab is an interleukin-17 monoclonal antibody.
Investigators sought to evaluate the efficacy and safety of brodalumab up to 120 weeks. The randomized, double-blind, placebo-controlled, and active comparator-controlled phase 3 trial included patients aged 18-75 years who were diagnosed with moderate to severe plaque psoriasis (ClinicalTrials.gov Identifier: NCT01708603).
Participants were randomly assigned to receive brodalumab (140 mg or 210 mg every 2 weeks), ustekinumab, or placebo during the 12-week induction phase. A maintenance phase through week 52 followed, during which patients who received brodalumab were randomly assigned to receive brodalumab 140 mg every 2, 4, or 8 weeks, or 210 mg every 2 weeks.
Patients who received ustekinumab continued that treatment, and patients who received placebo were switched to brodalumab 210 every 2 weeks. Efficacy, as measured by skin clearance, was monitored through week 120 by the static physician’s global assessment (sPGA) and psoriasis area and severity index (PASI). Safety was assessed by monitoring treatment-emergent adverse events.
In patients who received continuous brodalumab 210 mg every 2 weeks, skin clearance was maintained from week 52 through week 120. At week 52, patients who received ustekinumab who switched to brodalumab 210 mg every 2 weeks experienced an increased sPGA score of 0 or 1 and PASI 100 response rates that were 43.4% at week 52, increased to 60.7% by week 56, and remained stable through week 120.
Patients who received continuous brodalumab 210 mg every 2 weeks achieved PASI 100 response rate of 64.8% at week 52, which was maintained through week 120. Similar rates of serious adverse events (SAEs) were observed across all treatment groups.
The overall exposure-adjusted rate of treatment-emergent AEs in all patients who received any dose of brodalumab in the long-term extension was 306.9 per 100 patient-years from the beginning to the end of the study. Similar AEs were seen in all treatment groups.
These findings suggest that brodalumab may be well-suited for long-term treatment of moderate-to-severe plaque psoriasis in patients who received prior systemic therapy. Most patients who received brodalumab 210 mg every 2 weeks following treatment with ustekinumab achieved complete skin clearance after 120 weeks.
Several authors acknowledge affiliations with the pharmaceutical industry. Please see reference for a full list of disclosures.
Puig L, Lebwohl M, Bachelez H, Sobell J, Jacobson AA. Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator–controlled phase 3 AMAGINE-2 trial [published online June 5, 2019]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2019.05.095