A phase 2 trial of lutikizumab, an anti–interleukin 1α/β dual variable domain immunoglobulin, in knee osteoarthritis patients with synovitis
Arthritis & Rheumatology Jan 23, 2019
Fleischmann R, et al. – Researchers explored the efficacy and safety of anti-interleukin (IL)-1α/β dual variable domain immunoglobulin lutikizumab (ABT-981) in 347 patients with Kellgren-Lawrence grade 2–3 knee osteoarthritis (OA) and synovitis, determined by MRI or ultrasound. Eligible study participants were randomized to receive lutikizumab 25 mg, 100 mg, 200 mg, or placebo subcutaneously biweekly for 50 weeks. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain index at week 16 and change from baseline in MRI synovitis at week 26 comprised the coprimary endpoints. Researchers observed an initial improvement in WOMAC pain at week 16 with lutikizumab 100 mg only. They noticed no significant variations between symptoms at baseline in MRI synovitis at week 26 and structure-related endpoints at weeks 26 and 52 for lutikizumab and placebo. They also noted frequent injection site reactions, neutropenia, and discontinuations due to neutropenia with lutikizumab vs placebo. A rise in neutrophil and high-sensitivity C-reactive protein reductions were observed with lutikizumab 100 mg. Overall, they found IL-1 inhibition, a non-effective analgesic/anti-inflammatory treatment.
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