Bimekizumab safe, effective in moderate-to-severe plaque psoriasis
The high clinical response levels achieved with bimekizumab over 48 weeks persist up to week 96 in patients with moderate-to-severe plaque psoriasis, results of the BE RADIANT phase IIIb trial have shown. In addition, those on secukinumab who switched to bimekizumab have achieved similar responses at 96 weeks.
“Bimekizumab was well-tolerated with longer-term exposure and in patients who switched from secukinumab without washout or induction,” the researchers said. “Overall, safety data were consistent with the known safety profile.”
This randomized controlled trial consisted of a 48-week double-blinded period, in which patients received bimekizumab (320 mg every 4 or 8 weeks) or secukinumab (300 mg weekly to week 4, then every 4 weeks), and an open-label extension (OLE). In the OLE, all patients were treated with bimekizumab from week 48.
More patients on bimekizumab than on secukinumab (74.8 percent vs 52.8 percent) achieved complete skin clearance (Psoriasis Area and Severity Index [PASI] 100; modified nonresponder imputation) at week 48. [J Am Acad Dermatol 2023;89:486-495]
PASI 100 responses were sustained at week 96 in continuous bimekizumab patients (70.8 percent). Moreover, patients who switched from secukinumab to bimekizumab also achieved high clinical response at week 96 (76.6 percent).
Adverse events (AE) that commonly occurred among patients were nasopharyngitis, oral candidiasis, and urinary tract infection. Rates of AE in continuous bimekizumab patients in the OLE generally decreased or remained consistent relative to 1-year data. [N Engl J Med 2021;385:142-152]
Additionally, AEs in secukinumab patients who switched to bimekizumab were similar to those observed with bimekizumab through 1 year, indicating no further safety risk when switching within the interleukin (IL)-17 inhibitor class.
The IL-17 pathway is responsible for host defense against fungal infections at mucosal surfaces. The more complete blockage of IL-17-mediated immune pathways via dual IL-17A/F inhibition with bimekizumab has previously resulted in higher rates of oral candidiasis. [N Engl J Med 2021;385:142-152]
Although treatment with bimekizumab contributes to an increased rate of Candida infections relative to other IL-17 inhibitors, serious AEs rarely occur. [JAMA Dermatol 2022;158:735-744; J Am Acad Dermatol 2016;75:83-98.e84; Dermatol Ther (Heidelb) 2020;10:133-150; Br J Dermatol 2017;177:1537-1551]
“These data indicate that longer-term bimekizumab treatment and switching from another anti-IL-17 biologic to bimekizumab are generally well-tolerated and efficacious treatment options for patients with moderate-to-severe plaque psoriasis,” the researchers said.
Notably, prior research has found the association of psoriasis with several comorbidities such as obesity, diabetes, and hyperuricaemia, which can affect hepatic function. [J Eur Acad Dermatol Venereol 2020;34:533-541]
“Psoriasis can significantly impact patients’ quality of life and mental well-being,” the researchers said. “[W]hen assessing efficacy, considering both patient-reported and clinical outcomes is important.” [PLoS One 2012;7e52935; Expert Rev Pharmacoecon Outcomes Res 2014;14:559-568; Am J Clin Dermatol 2005;6:383-392; Dermatol Ther (Heidelb) 2021;11:1551-1569]
The current study was limited by the lack of racial diversity and overlap with the COVID-19 pandemic.