Bimekizumab shows long-term efficacy, tolerability in psoriatic arthritis
Click Here to Manage Email Alerts
PHILADELPHIA — Interleukin-17 inhibition with bimekizumab yields strong joint and skin effects up to week 52 in patients with active psoriatic arthritis, according to data presented at ACR Convergence 2022.
“Bimekizumab has demonstrated efficacy and safety up to week 24 in the pivotal phase 3 BE OPTIMAL study and was well-tolerated up to 52 weeks in the phase 2b study in patients with active psoriatic arthritis,” Christopher Ritchlin, MD, of the University of Rochester Medical Center, told attendees. “The objective of the study was to assess the long-term efficacy and safety of subcutaneous bimekizumab in biologic DMARD-naïve patients with active PsA up to week 52.”
Patients met PsA Classification Criteria for at least 6 months. The analysis included 852 patients and used ACR50 as the primary endpoint.
Treatment regimens included subcutaneous bimekizumab (Bimzelx, UCB) 160 mg every 4 weeks (n = 431), adalimumab 40 mg every 2 weeks (n = 140) or placebo (n = 281). After week 16, patients in the placebo arm could be switched to bimekizumab at 160 mg every 4 weeks through week 52.
According to the researchers, week 52 results demonstrated that 53% of patients in the placebo arm who switched to bimekizumab achieved ACR50 response, compared with 54.5% of patients in the original bimekizumab arm who reached this endpoint, and 50% of those in the adalimumab arm.
“Note the rapid rise in response in the bimekizumab group that had previously been on placebo through week 16,” Ritchlin said.
Meanwhile, 65% of patients in the placebo/bimekizumab switch arm achieved complete skin clearance, as assessed by the Psoriasis Area and Severity Index (PASI) 100 parameter, compared with 60.8% of those in the bimekizumab arm and 48.5% of those in the adalimumab arm.
“Again, note the rapid rise from the placebo phase through active therapy,” Ritchlin said.
Rates for achieving minimal disease activity were 53.7% for placebo/bimekizumab, 55% for bimekizumab and 52.9% for adalimumab.
Regarding radiographic progression, Ritchlin noted that 87.3% of patients in the placebo/bimekizumab arm did not progress through week 52, compared with 89.3% in the bimekizumab arm and 94.1% for adalimumab.
Safety data demonstrated that nasopharyngitis, upper respiratory infections and urinary tract infections were most commonly reported adverse events, according to the researchers. Oral candidiasis was observed in about 5% of patients in the bimekizumab arm, which Ritchlin noted was “significantly higher” than what was reported for adalimumab. However, he noted that this outcome was not unexpected.
“I should point out that no patients had systemic candida infection,” he said.
“The phase 3 BE OPTIMAL study demonstrated long-term efficacy and tolerability of IL-17A and F inhibition with bimekizumab treatment in DMARD-naïve patients with PsA,” Ritchlin added. “Bimekizumab-treated patients with PsA demonstrated efficacy across both skin and joint outcomes, which were sustained from week 16 to week 52.”
Collapse
Ritchlin C. Abstract L02. Presented at: ACR Convergence 2022; Nov. 11-14, 2022; Philadelphia (hybrid meeting).
Read more about
Click Here to Manage Email Alerts