The dual targeting agent hits the mark for both psoriatic arthritis and axial spondyloarthritis.
Recently published 52-week open-label extensions of the bimekizumab phase III studies in psoriatic arthritis and axial spondyloarthritis show continued efficacy and safety of the drug.
This follows the FDA’s approval of bimekizumab for plaque psoriasis last Wednesday. Bimekizumab was approved for psoriatic arthritis and axial spondyloarthritis by the European Medicines Agency in June of this year, and was listed on the PBS for chronic plaque psoriasis at the beginning of this month.
The BE OPTIMAL study investigated the IL-17A/17F inhibitor in psoriatic arthritis, with earlier studies having found additional benefit of dual neutralisation over IL-17A inhibition alone on skin clearance in psoriasis.
“BE OPTIMAL demonstrated long-term efficacy of BKZ up to Week 52 in patients with active PsA who were bDMARD-naïve across a range of PsA domains, including joints, skin, enthesitis, dactylitis and nails, as well as the inhibition of structural progression,” wrote the authors in the Annals of the Rheumatic Diseases.
These clinically relevant improvements were accompanied by improvements in patient-reported outcomes, said the authors, including physical function, pain and fatigue. Meanwhile, the patient drop-out rate was low and no new safety signals were observed.
“Improvements seen with BKZ in the BE OPTIMAL study indicate a long-term, sustained depth of response,” concluded the authors.
The multicentre BE OPTIMAL trial included over 800 patients randomised 3:2:1 to BKZ treatment, placebo control or adalimumab active reference. The primary end point was ACR50 at week 16.
The percentage of patients achieving ACR50 at week 16 was sustained, with around half the patients in the BKZ and adalimumab treatment groups achieving ACR50 at week 52.
Improvements in skin among patients with ≥3% body surface area affected by psoriasis at baseline and responder rates for very low disease activity were also sustained to week 52, while the percentage of patients achieving minimal disease activity increased from week 16 to 52.
Almost 80% of BKZ patients experienced at least one treatment-emergent adverse event over the 52 weeks, a similar proportion to that experienced by adalimumab patients.
The most common adverse events for BKZ were nasopharyngitis, upper respiratory tract infection and urinary tract infection. There was an increased risk of fungal infections among BKZ-treated patients compared with the adalimumab group, mostly oral candidiasis.
Four major adverse cardiovascular events were reported in the BKZ group, representing 0.6% of patients, and all four patients had a history of cardiovascular disease. There were also seven reported malignancies. There were no major adverse cardiovascular events or malignancies in the adalimumab group.
Meanwhile, the results of the 52-week BE MOBILE open-label extension studies investigating efficacy and safety of BKZ for axSpA patients also demonstrated sustained efficacy from 16 weeks, with similar rates and type of adverse events.
“Dual inhibition of IL-17A and IL-17F with subcutaneous BKZ 160 mg Q4W led to clinically meaningful improvements in a range of efficacy outcomes, across the full disease spectrum of axSpA to Week 52,” wrote the authors in the Annals of the Rheumatic Diseases.
“In line with the sustained reductions in ASDAS [Ankylosing Spondylitis Disease Activity Score], BKZ resulted in improvements in measures of patient symptoms such as pain, morning stiffness, fatigue and physical function to Week 52.”
The BE MOBILE 1 study involved around 250 patients with non-radiographic axSpA, randomised 1:1 to BKZ or placebo. The BE MOBILE 2 study included around 330 patients with radiographic axSpA randomised 2:1 to BKZ or placebo.
The primary end point of ASAS40 at week 16 was achieved in both BE MOBILE studies, with around 60% of BKZ patients in the studies achieving ASAS40 response at week 52.
Disease activity, which was high or very high in almost all patients at baseline, improved in the BKZ groups, with the majority of patients achieving ASDAS low disease activity. There was also improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score in both studies. Other improvements included peripheral manifestations of axSpA, enthesitis and peripheral arthritis.
Around 75% of patients experienced at least one treatment-emergent adverse event, the most common being nasopharyngitis, upper respiratory tract infection and oral candidiasis. There were no major adverse cardiovascular events, and the two reported malignancies were assessed as not related to the study drug.
Pointing out that both PsA and axSpA are chronic, long-term diseases, the authors of both papers highlighted the importance of assessing the long-term efficacy and safety of treatment. Open-label extension studies assessing long-term safety and efficacy over three years for PsA and axSpA are currently underway.
BE OPTIMAL (PsA):
Annals of the Rheumatic Diseases 2023, online 12 October
BE MOBILE (axSpA):
