Lutikizumab
(ABT-981) is an anti-interleukin-1α/β (anti-IL-1α/β) dual variable domain immunoglobulin. I’ve
once discussed bispecific antibodies with
Prof. Burmester as I have concerns about the fact that each part is as strong
as the other and this might not reflect the need of each compound. Prof.
Burmester had a more practical approach as you don’t have to apply for two
different drugs in studies and later in looking for approval by agencies such
as the FDA or EMA. I remain skeptic.
There
has been a study by R.M. Fleischman and colleagues [1]: “A Phase II Trial of
Lutikizumab, an Anti-Interleukin-1α/β Dual Variable Domain Immunoglobulin, in
Knee Osteoarthritis Patients With Synovitis.” The authors found only a limited
improvement in the WOMAC pain score and a lack of synovitis improvement with
lutikizumab. The concluded further that “together with published results from
trials of other IL-1 inhibitors, suggest that IL-1 inhibition is not an
effective analgesic/antiinflammatory therapy in most patients with knee OA and
associated synovitis.”
M.
Kloppenburg and colleagues published a study [2]: “Phase IIa,
placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1α and
anti-interleukin-1β dual variable domain immunoglobulin, in patients with
erosive hand osteoarthritis.” The had chosen as primary endpoint a “change in
Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain subdomain score
from baseline to 16 weeks. At baseline and week 26, subjects had bilateral hand
radiographs and MRI of the hand with the greatest number of baseline tender
and/or swollen joints.” The authors concluded: “Despite adequate blockade of IL-1,
lutikizumab did not improve pain or imaging outcomes in erosive HOA [erosive
hand osteoarthritis] compared with placebo.”
I said: I remain skeptic. I don’t see a niche for
lutikizumab in the treatment of osteoarthritis. Bye bye!
Links:
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