Friday, June 28, 2019

Lutikizumab in Osteoarthritis


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!


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