Brodalumab substantially improves symptoms in psoriatic arthritis, reports Study
Brodalumab is associated with rapid and significant improvements in signs and symptoms of PsA versus placebo. It also seems to be well tolerated, with a safety profile consistent with other interleukin-17 inhibitors, reported a recent study published in the Annals of the Rheumatic Diseases.
Current treatment guidelines for Psoriatic arthritis recommend biologic disease-modifying antirheumatic drugs (DMARDs) as a treatment option on the inadequate response following treatment with non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and conventional synthetic DMARDs. Despite the advent of therapeutics, an unmet need remains in PsA as a significant proportion of patients either do not respond or eventually lose response to currently available therapies.
However, Brodalumab 210mg is currently approved for the treatment of moderate-to-severe plaque psoriasis in the USA, EU, Canada, and certain Asian countries and for PsA currently only in Japan. The safety profile of brodalumab in PsA was consistent with the safety profile established in the psoriasis clinical trial program, and the clinical responses were sustained.
Therefore, to further evaluate the efficacy and safety of brodalumab in PsA, two double-blind, randomized, phase III trials, AMVISION-1 (NCT02029495) and AMVISION-2 (NCT02024646), was conducted. The primary objective of both trials was to compare the efficacy of brodalumab with placebo in patients with PsA. Both trials were placebo-controlled through week 24. Data at week 16 from individual trials and week 24 from a pooled analysis were observed, describes Philip J Mease and colleagues from the Rheumatology Research, Swedish Medical Center, Seattle, Washington, USA.
The authors studied a total of 962 adult patients with active PsA and inadequate response to, or intolerance to, conventional treatment who were randomized to receive subcutaneous brodalumab 140mg or 210mg or placebo at weeks 0, 1, and every 2 weeks up to 24 weeks. About 30% of patients had prior use of biologics. The primary endpoint for both studies was the American College of Rheumatology 20 (ACR20) response at week 16.
The following key observations were extracted-
- More patients achieved ACR20 at week 16 in both brodalumab treatment groups (45.8% and 47.9% for 140mg and 210mg, respectively) versus placebo (20.9%).
- Significantly higher proportions of patients receiving brodalumab achieved ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis versus placebo.
- Adverse event rates were similar across treatments at week 16 (54.4%, 51.6% and 54.5% for placebo, brodalumab 140mg and 210mg, respectively).
Hence, the authors concluded that "Brodalumab was associated with rapid and significant improvements in signs and symptoms of PsA versus placebo. Brodalumab was well tolerated, with a safety profile consistent with other interleukin-17 inhibitors."