Phase 2b study results show durable responses rates and symptom improvement in patients with psoriatic arthritis.
An investigational treatment, bimekizumab (UCB), showed promising response rates and symptom improvement in patients with psoriatic arthritis (PsA), according to long-term data presented at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting.
Bimekizumab is a novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-7A and IL-17F, 2 key cytokines driving inflammatory processes, according to a UCB press release.
The phase 2b BE-ACTIVE study evaluated the dose response, long-term efficacy, and safety of bimekizumab in 206 adults with PsA over a 48-week treatment period. Patients were grouped based on 5 dose regimens, receiving either a placebo or bimekizumab every 4 weeks by subcutaneous injection for 12 weeks. After week 12, patients receiving placebo or bimekizumab 16 mg either received bimekizumab 160 mg or 320 mg, while all other patients continued on their previous dose.
Overall, the study showed that 46% of patients with PsA who received bimekizumab experienced at least 50% improvement in PsA signs and symptoms (ACR50) compared with 7% with placebo at week 12. These results were maintained to week 48 across doses.
At week 48, ACR20/50/70 response rates were 70%/55%/43% for the 160-mg dose, 73%/57%/46% for the 160-mg dose with a loading dose, and 76%/63%/39% for the 320-mg dose, respectively. Psoriasis Area and Severity Index (PASI90) response rates at week 48 were 70% for the 160-mg dose with and without a loading dose and 85% for the 320-mg dose, according to the study.
The number of patients who achieved minimal disease activity continued to increase from week 12 (29% to 46%) to week 24 (37% to 60%) across dose ranges and response rates were maintained through week 48 across the same dosage ranges.
By the end of the study, 4.4% patients reported serious adverse events at all doses, with nasopharyngitis being the most frequently reported adverse event at 12.1%.
“The results observed with bimekizumab are impressive, as they demonstrate the potential long-term maintenance of deep response in rigorous skin and joint outcomes,” Christopher T. Ritchlin, MD, MPH, University of Rochester Medical Center, said in a statement. “The results from BE ACTIVE support the substantial value of neutralizing IL-17F in addition to IL-7A in the treatment of psoriatic arthritis.”
Bimekizumab is also being evaluated for other diseases, including psoriasis and ankylosing spondylitis, according to the release.
Bimekizumab Showed Sustained Improvements in Both Joint and Skin Outcomes for Psoriatic Arthritis Patients [news release]. UCB’s website. https://bit.ly/2AFIrPy. Accessed October 24, 2018.