TY - JOUR T1 - 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 JF - Annals of the Rheumatic Diseases JO - Ann Rheum Dis SP - 413 LP - 420 DO - 10.1136/annrheumdis-2018-213336 VL - 78 IS - 3 AU - Margreet Kloppenburg AU - Charles Peterfy AU - Ida K Haugen AU - Féline Kroon AU - Su Chen AU - Li Wang AU - Wei Liu AU - Gwen Levy AU - Roy M Fleischmann AU - Francis Berenbaum AU - Désirée van der Heijde AU - Prashant Bansal AU - Ruth Wittoek AU - Sheng Feng AU - Yuni Fang AU - Mary Saltarelli AU - Jeroen K Medema AU - Marc C Levesque Y1 - 2019/03/01 UR - http://ard.bmj.com/content/78/3/413.abstract N2 - Objective To assess the efficacy, safety, pharmacokinetics and pharmacodynamics of the anti-interleukin (IL)-1α/β dual variable domain immunoglobulin lutikizumab (ABT-981) in erosive hand osteoarthritis (HOA).Methods Patients with ≥1 erosive and ≥3 tender and/or swollen hand joints were randomised to placebo or lutikizumab 200 mg subcutaneously every 2 weeks for 24 weeks. The primary endpoint was 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. Continuous endpoints were assessed using analysis of covariance models, with treatment and country as main factors and baseline measurements as covariates.Results Of 132 randomised subjects, 1 received no study drug and 110 completed the study (placebo, 61/67 (91%); lutikizumab, 49/64 (77%)). AUSCAN pain was not different among subjects treated with lutikizumab versus placebo at week 16 (least squares mean difference, 1.5 (95% CI –1.9 to 5.0)). Other clinical and imaging endpoints were not different between lutikizumab and placebo. Lutikizumab significantly decreased serum high-sensitivity C reactive protein levels, IL-1α and IL-1β levels, and blood neutrophils. Lutikizumab pharmacokinetics were consistent with phase I studies and not affected by antidrug antibodies. Injection site reactions and neutropaenia were more common in the lutikizumab group; discontinuations because of adverse events occurred more frequently with lutikizumab (4/64) versus placebo (1/67).Conclusion Despite adequate blockade of IL-1, lutikizumab did not improve pain or imaging outcomes in erosive HOA compared with placebo. ER -