The anti-interleukin-1 (IL-1) antibody lutikizumab may not improve pain or inflammation in patients with knee osteoarthritis (OA) and concomitant synovitis, according to the results of a phase 2 study published in Arthritis & Rheumatology.
Researchers conducted a double-blind placebo-controlled randomized study of 350 patients with knee OA and associated synovitis. Study participants received either placebo or lutikizumab 25 mg, 100 mg, or 200 mg given subcutaneously every 2 weeks for a total of 50 weeks. The co-primary outcomes measured were change in pain score from the initiation of therapy to 16 weeks using the Western Ontario and McMaster Universities Osteoarthritis pain index (WOMAC) and changes in magnetic resonance imaging (MRI)-evaluated synovitis from the start of treatment to 26 weeks.
After statistical analysis, the investigators found that pain scores were bettered significantly vs placebo in patients in the lutikizumab 100-mg group (P =.050) but not in patients in the 25-mg (P =.834) and 200-mg (P =.415) groups. In addition, MRI-assessed changes in synovitis did not differ between the groups.
Regarding safety, neutropenia, allergic reactions, and therapy discontinuation due to adverse effects occurred more often with lutikizumab vs placebo.
“The results of this study suggest that IL-1 inhibition is not an effective disease-modifying therapy in patients with knee OA,” the researchers wrote.
“Whether subgroups of [patients with knee OA] might have symptomatic benefit from IL-1 inhibition remains an open question,” they concluded.
Fleischmann RM, Bliddal H, Blanco FJ, et al. A phase 2 trial of lutikizumab, an anti-interleukin 1 alpha/beta dual variable domain immunoglobulin, in knee osteoarthritis patients with synovitis [published online January 17, 2019]. Arthritis Rheumatol. doi:10.1002/art.40840