Jeffrey Stark, MD: Latest Bimekizumab Data for Treatment of Psoriatic Arthritis, Psoriasis

Rheumatology Network interviewed Jeffrey Stark, MD, to discuss the latest bimekizumab data presented at the 2022 American Academy of Dermatology (AAD) conference. Stark is the Head of Immunology Medical Affairs at UCB.

Stark explains, “The highlight of the data presented on bimekizumab at the recent AAD meeting was a late breaking oral presentation that combined data from 5 phase 3b clinical trials in plaque psoriasis. Looking at those patients over a long period of time, now being followed through 2 years in open label extension, we saw that patients who achieve completely clear skin, a Psoriasis Area and Severity Index (PASI) 100 score, in the placebo-controlled portion of the trial maintained that completely clear skin in 8 out of 10 cases over a 2-year period of follow up. We've been very excited about the robust clinical responses seen in the placebo-controlled portions of these trials, but very excited to see now over a 2-year period that those results are lasting for a significant majority of the patients who are enrolled in those open label extensions.”

New information on the BE ACTIVE study, previously covered on Rheumatology Network, was also presented at this year’s AAD meeting.

“The BE ACTIVE study relates back to data that spans more than 1 disease state and are of interest to more than 1 therapeutic community. We recognize that psoriatic arthritis is a disease state that's of intrinsic interest to both the rheumatology and the dermatology communities,” Stark added. “BE ACTIVE was a randomized, double blind, placebo-controlled, dose-ranging phase 2b study in patients with psoriatic arthritis. We had the opportunity to share both short-term and long-term results from that study. Among the short-term results, we looked at joint responses at week 12. According to typical thresholds of the American College of Rheumatology improvement criteria, those with ACR20, ACR50, and ACR70 responses were 62%, 37%, and 22%, respectively. But we now have the opportunity to share data from the 3-year period of follow up into the open label extension period of this study. We saw in that 3-year follow up that those responses were well-maintained by those patients who benefited in the earlier portions of the study. When we looked at those according to a non-responder imputation, we saw a maintenance of more than 70% over 3 years. When looked at by an observed case methodology, that rose to around 90%. But either way, very exciting stability of clinical response in those patients who achieved a good clinical response earlier studies.”

We briefly touched on certolizumab pegol, a treatment for adults with moderate-to-severe plaque psoriasis, data presented at the conference. Studies evaluated this treatment’s effects on anxiety, depression, and fatigue in this patient population.

“In the [first] study, we sought to investigate the overall impact of certolizumab pegol, over a 3-year period on depression and anxiety, as assessed by the Hospital Anxiety and Depression Scale (HADS),” Stark explains. “We looked at patients who had depression or anxiety at baseline according to that score. When it comes to anxiety, we had 13.3% of patients who had a HADS anxiety score of 13 or more, representing a clear diagnosis of anxiety of those patients. By the end of the study, which was at week 144, we saw that 31.3% of them had dropped to a HADS anxiety score of 7 or less, meaning no clinically active anxiety. That was a positive change for us to see. The pattern was quite similar regarding depression. Patients who experienced significant depression, that is those who had a HADS depression score of 13 or higher, was 9.7% of patients at baseline. By the end of the study, 55.9% of them had dropped below a threshold of 7, meaning that they had no active clinically significant depression at that point in time after this period of receiving certolizumab pegol.”

Focusing on fatigue, Stark states, “The CIMPACT trial was also a study of certolizumab pegol in patients with moderate-to-severe plaque psoriasis. This study is a great reminder that psoriasis is much more than a skin disease. It truly is a state of systemic inflammation and affects people accordingly. Fatigue is a very common symptom that people with psoriasis experience.”

“In the CIMPACT study, we had the opportunity to look at both the short- and long-term effect of certolizumab pegol on fatigue in patients with plaque psoriasis using the Fatigue Assessment Scale (FASca) score. What was seen in that study, over a period of 3 years of follow up, was that treatment with certolizumab was associated with numerical decreases in the FASca score, reflecting an improvement in fatigue over that period. So again, it’s exciting data for Cimzia, or certolizumab pegol, as a medication, but certainly a great reminder that fatigue is something we should be concerned about in our patients and strive to help them with as well.”

“We’ve had a great opportunity to talk about some of the latest data presented for bimekizumab in the areas of plaque psoriasis, as well as psoriatic arthritis,” Stark concludes. “What may be interesting to your readers is to also be aware that ongoing phase 3 programs are underway for bimekizumab in other disease states. Those include axial spondyloarthritis, encompassing both ankylosing spondylitis and non-radiographic axial spondyloarthritis, and in another disease states in dermatology. We're excited about those ongoing programs and look forward to the opportunity at future scientific meetings to share those data as well as they become available.”