New long-term complete skin clearance data for bimekizumab in moderate to severe plaque psoriasis presented at the 2022 AAD annual meeting.- UCB

The platform presentation details new analysis of pooled data from five bimekizumab Phase III/IIIb clinical trials , which showed that over 80 percent of patients who achieved complete skin clearance (PASI100) at week 16 and entered the open-label extension (OLE) studies maintained this response through two years follow up, and no new safety signals were identified.

Among the poster presentations, new data from the OLE period of the Phase IIIb BE RADIANT study showed that clinical responses (PASI100 and absolute PASI, PASI less than 2) achieved at week 48 were maintained through week 96 with continuous treatment with bimekizumab and improved for patients who switched from secukinumab to bimekizumab on entry to the OLE. Patients who were PASI90 non-responders with secukinumab at week 48 achieved improved clinical responses (PASI90 and PASI100) after switching to bimekizumab in the OLE. Among patients who were PASI90 responders with secukinumab at week 48, PASI90 response was maintained and PASI100 response increased following switch to bimekizumab in the OLE.

Phase III/IIIb studies: two-year pooled data for bimekizumab in patients with moderate to severe plaque psoriasis:Data were pooled from the BE VIVID, BE READY, and BE SURE Phase III trials, the Phase IIIb BE RADIANT trial and OLE (48 weeks), and the first year of the BE BRIGHT OLE study . Analysis evaluated PASI100 maintenance through two years (OLE 48 weeks) among PASI100 week 16 responders who entered the respective OLE studies and received continuous bimekizumab maintenance dosing from week 16 (320 mg every four weeks [Q4W/Q4W/Q4W] or Q4W/Q8W/Q8W). At week 16, 62.4 percent of bimekizumab-treated patients (n=850) achieved PASI100. Of those who entered the OLEs, 85.1 percent (Q4W/Q4W/Q4W; n=316) and 83.8 percent (Q4W/Q8W/Q8W; n=267) maintained PASI100 at year two (OLE week 48).

The exposure-adjusted incidence rates (EAIRs) of overall and serious treatment emergent adverse events (TEAEs) were 192.7 and 5.9. The most common TEAEs were nasopharyngitis (EAIR of 18.4), oral candidiasis (13.0) and upper respiratory tract infections (7.8). Almost all cases of oral candidiasis (98.1 percent) were mild or moderate.

BE RADIANT open-label extension study in patients with moderate to severe plaque psoriasis: efficacy and safety data through 96 weeks: Complete skin clearance (PASI100) levels observed with bimekizumab in the BE RADIANT study were maintained in the OLE through week 96 (74.8 percent and 70.6 percent at weeks 48 and 96, respectively) and improved for patients who switched from secukinumab to bimekizumab on entry to the OLE period (52.8 percent and 76.1 percent at weeks 48 and 96, respectively). The absolute PASI response (PASI less than 2) was also maintained through week 96 (94.3 percent and 93.4 percent at weeks 48 and 96, respectively) and improved for patients who switched from secukinumab to bimekizumab on entry to the OLE period (83.9 percent and 94.6 percent at weeks 48 and 96, respectively).

During the OLE, the most common adverse events with bimekizumab were nasopharyngitis (11.8/100 patient-years), oral candidiasis (7.8/100 patient-years), and urinary tract infection (4.5/100 patient-years). Adverse events were comparable between patients continuing bimekizumab or switching from secukinumab to bimekizumab. The incidence of serious adverse events was low. These analyses included 336 patients treated with bimekizumab, and 318 patients treated with secukinumab who completed the BE RADIANT double-blinded period and entered the OLE.

BE RADIANT open-label extension study in patients with moderate to severe plaque psoriasis: responder analysis in patients switching from secukinumab to bimekizumab : At week 48, 53/318 patients (16.7 percent) treated with secukinumab had not achieved PASI90. After switching to bimekizumab in the OLE, responses improved. At week 96, 79.2 percent of this group achieved PASI90 and 50.9 percent achieved PASI100. At week 48, 256/318 patients (80.5 percent) treated with secukinumab had achieved PASI90. After switching to bimekizumab in the OLE, 95.2 percent of this group maintained this response at week 96 and the PASI100 response increased from 65.2 percent at week 48 to 79.9 percent at week 96. No clinically relevant differences in safety outcomes for patients who switched from secukinumab to bimekizumab were observed from weeks 48-96.

Modified non-responder imputation analyses :About the BE READY, BE VIVID and BE SURE studies and the BE BRIGHT open-label extension study: The efficacy and safety of bimekizumab in the treatment of adults with moderate to severe plaque psoriasis were evaluated in three Phase III studies, versus placebo and ustekinumab (BE VIVID), versus placebo (BE READY) and versus adalimumab (BE SURE). Patients who completed one of these three Phase III studies were eligible to enroll in the BE BRIGHT open-label extension study.