High Bimekizumab Response Levels Maintained at 3 Years in Psoriasis

Among patients with moderate to severe plaque psoriasis, high response levels at week 16 were sustained in most patients through 3 years of bimekizumab therapy, according to study findings published in British Journal of Dermatology.

Researchers assessed pooled data from the BE VIVID, BE READY, BE SURE, and BE BRIGHT OLE trials through year 3. The trials were conducted in 13 countries from Europe, North America, Asia, and Australia and included adults with moderate to severe plaque psoriasis.

Participants were randomly assigned to receive bimekizumab 320 mg every 4 weeks (Q4W) at baseline in the feeder study. They had to meet the efficacy response at week 16, continually received bimekizumab 320 mg Q4W or every 8 weeks (Q8W) throughout the maintenance period, and were enrolled in BE BRIGHT OLE.

Efficacy outcomes were based on 3 years of bimekizumab therapy as the maintenance of Psoriasis Area and Severity Index (PASI) scores of 90, 100, or 2 or less, and a BSA score of 1% or less in participants who had the efficacy response of interest at week 16.

A total of 865 (87.5%) participants who received bimekizumab 320 mg Q4W in the initial period of the feeder studies achieved PASI 90 at week 16, of whom 693 continued receiving bimekizumab in the maintenance period and entered OLE, and 186 of whom received bimekizumab Q4W or Q8W. Among the week 16 PASI 90 responders, 96.5% and 93.0% had a sustained PASI 90 response at years 1 and 3 of bimekizumab treatment, respectively.

Among week 16 PASI 90 responders who entered OLE, 72.5% had achieved PASI 100 at week 16. In week 16 PASI 90 responders, 73.4% achieved PASI 100 at 3 years.

A PASI 100 response at week 16 was achieved by 620 (62.7%) participants treated with bimekizumab Q4W in the initial period of the feeder studies, of whom 503 continued to receive bimekizumab in the maintenance period and entered OLE, 147 of whom received bimekizumab Q4W or Q8W. For all week 16 PASI 100 responders, 89.3% and 80.8% had a sustained PASI 100 response at 1 and 3 years of bimekizumab treatment, respectively. For participants who had continuous bimekizumab Q8W maintenance dosing (Q4W/Q8W), 93.6% and 82.0% maintained PASI 100 at 1 and 3 years, respectively.

Among the 330 week 16 PASI 100 responders, 92.0% and 89.0% had a Dermatology Life Quality Index score of 0 or 1 at 1 and 3 years, respectively. A PASI score of 2 or less continued through year 3 in 94.0% of all patients who received bimekizumab and 97.2% of those who received continuous bimekizumab Q8W maintenance dosing (Q4W/Q8W).

Body surface area of 1% or less was maintained at 3 years in 90.3% of all patients treated with bimekizumab and 94.3% of those who received continuous bimekizumab Q8W maintenance dosing (Q4W/Q8W).

Limitations of the study include the use of a responder analysis, which does not account for participants with an early partial response or nonresponders who later become full responders. Also, analysis of long-term maintenance of response does not include participants who discontinued treatment before week 16.

“The data reported here indicate that long-term treatment with bimekizumab is efficacious, with additional important benefits on health-related quality of life, in patients with moderate to severe plaque psoriasis,” conclude the investigators.

Disclosure: These studies were sponsored by UCB Pharma. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.