Interleukin-17 receptor A inhibitor brodalumab is safe and effective for the long-term treatment of plaque psoriasis, according to study research published in the Journal of Dermatology.
A total of 129 patients with plaque psoriasis with/without psoriatic arthritis were recruited into an open-label extension study performed at 54 sites throughout Japan. Patients in this study had previously completed a 64-week treatment period with brodalumab 140 mg or 210 mg every 2 weeks.
The researchers sought to identify long-term safety and efficacy outcomes with a reduced 140-mg dose of brodalumab administered on day 1 and once every 4 weeks afterward, followed by either dose maintenance or a switch to a minimum dose of 140 mg every 8 weeks to a maximum 210-mg dose every 2 weeks. Following drug approval, all patients switched to 210 mg every 2 weeks.
In all, 82.9% (n=107) of patients completed ≥108 weeks of the extension study and were included in this analysis. Throughout the follow-up period, low scores were observed for the Psoriasis Area and Severity Index (weeks 28 and 108: 1.00 and 0.20, respectively) and Dermatology Life Quality Index (weeks 28 and 108: 1.00 and 0.00, respectively). Improvements observed in the Psoriasis Scalp Severity Index, Nail Psoriasis Severity Index, and American College of Rheumatology 20, 50, and 70 were also maintained during the 180 weeks.
The investigators found no new safety signals with brodalumab throughout the open-extension study. Nasopharyngitis (n=29), influenza (n=9), and oral candidiasis (n=9) were the most commonly reported treatment-related adverse events (TRAEs). The serious TRAEs included appendicitis (n=1), brain abscess (n=1), bacterial meningitis (n=1), colon cancer (n=1), immunoglobulin A nephropathy (n=1), and tubulointerstitial nephritis (n=1).
Limitations of the study include the single-arm design and the lack of baseline assessment of the Patient Health Questionnaire 8 for depression.
The investigators concluded that “the severity of psoriasis and health-related quality of life were well controlled throughout the study period with brodalumab.”
Disclosure: This clinical trial was supported by Kyowa Kirin. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Yamaguchi Y, Takatsu N, Ootaki K, Nakagawa H. Long-term safety of brodalumab in Japanese patients with plaque psoriasis: An open-label extension study [published online April 10, 2020]. J Dermatol. doi: 10.1111/1346-8138.15343