Positive results for bimekizumab are good news for this a difficult-to-treat patient group.
In Australia, TNF inhibitors (TNFi) have been on the PBS since 2004 and they are the most used of the biologic DMARDs in all our autoimmune inflammatory arthritis.
What are our medication options when our patients with psoriatic arthritis have an inadequate response to TNFi?
The PBS provides us a lot of choice and we are lucky to have two IL-17 inhibitors, an IL-23 inhibitor, an IL12/23 inhibitor, two JAK inhibitors and multiple other TNFi.
Well, there is going to be a new contender.
Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits both IL-17F and IL-17A. Safety and efficacy has been established in many trials in psoriasis and it has also been shown to be effective in psoriatic arthritis (PsA).
The BE COMPLETE RCT looks at BKZ in those with PsA who were inadequate responders or intolerant to one to two anti-TNFs.
Patients who had tried other specialised DMARDs were excluded. A history of inflammatory bowel disease (IBD) was allowed but those with active IBD were excluded.
A total of 388/400 (97.0%) patients completed 16 weeks with 263 on BKZ and 25 on placebo (PBO). Baseline characteristics were comparable between groups.
The results were impressive. All primary and secondary endpoints were met at week 16, including:
- ACR50 43.4% vs 6.8%
- PASI90 68.8% vs 6.8%
- PASI100 58.5% vs 4.5%
- MDA 44.2% vs 6%
- Composite of ACR50 + PASI100 33.5% vs 1.1%
- Nail psoriasis resolution 45.9% vs 14.5%
Nasopharyngitis was more common in the treated group, 3.7% vs 0.8% in the PBO group. There were 12 fungal infections (none systemic) in the treatment group vs 0 in the placebo group. There were not any cases of new IBD or suicidal ideation.
Bimekizumab seems very effective without any unexpected safety signals.
1599. Bimekizumab Treatment in Patients with Active Psoriatic Arthritis and Inadequate Response to Tumor Necrosis Factor Inhibitors: 16-Week Efficacy and Safety from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
